Mitigation of Major Hip Injury Due to Fall in an At-Risk, Older Adult Population With a Wearable Smart Belt
Phase: NA
Conditions: Hip Injuries, Fractures, Hip, Fall Injury, Fall Risk, Osteoporosis, Osteoporosis Risk
Sponsor: ActiveProtective Technologies, Inc



 
 
 
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Study Title: Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult Population with a 
Wearable Smart Belt 
 
Short Title: Smart Belt Fall Injury Mitigation Study 
 
Reference ID/Protocol#: COP-0001 
Single Identification Number: Pro00061055 (Advarra Protocol ID) 
Version: 2.0 
 
Date: April 18, 2022 (Original version dated January 28, 2022) 
 
Study Product: Tango® Belt 
 
Study Type: Multi-center, comparative, non-significant risk study with retrospective controls 
 
IDE Reference Number: N/A 
 
Study Sponsor:    Active Protective Technologies, Inc 
 
 
  580 Virginia Dr, Suite 230 
 
 
  Fort Washington, PA 19034 
 
Sponsor Contact:  Wamis Singhatat, CEO 
 
 
    580 Virginia Dr; Suite 230 
 
 
    Fort Washington, PA 19034 
 
 
 
  
 
    Rebecca J Tarbert, Director of Clinical Programs 
 
 
    580 Virginia Dr; Suite 230 
 
 
    Fort Washington, PA 19034 
 
Protocol Approval on behalf of Active Protective Technologies, Inc by:   
     Wamis Singhatat, CEO Active Protective Technologies, Inc 
     580 Virginia Dr; Suite 230 
                   Fort Washington, PA 19034 
 
 
Date: ___________________________  
Signature: ___________________________________ 
 
The information contained herein is provided to you in confidence and should not be disclosed to others, 
without written authorization from Active Protective Technologies, Inc, except to the extent necessary to 
obtain informed consent from those persons to whom the device will be administered. Privacy and 
confidentiality of information about each subject shall be preserved in the reports and any publication of 
the clinical investigation data. Lists of subject’s names and identifying information should, wherever 
possible, be maintained separately from Case Report Forms. All data shall be secured against 
unauthorized access. 

 
 
 
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List of Abbreviations and Definitions of Terms 
 
ADE  
Adverse device effect  
AE  
Adverse event  
APT 
Active Protective Technologies, Inc 
BIMS 
Brief Interview for Mental Status  
CIB  
Clinical Investigators Brochure  
CIP 
Clinical Investigation Plan (Protocol)  
CRA  
Clinical Research Associate  
CRF  
Case Record Form  
EC  
Ethics Committee  
EMR 
Electronic Medical Record 
FDA  
Food and Drug Administration  
FES-I  
Falls Efficacy Scale - International 
GCP  
Good Clinical Practice  
ICF 
Informed Consent Form 
IRB  
Institutional Review Board  
ISO  
International Organization for Standardization  
LAR  
Legally Authorized Representative 
MDS 
Minimum Data Set 
QC  
Quality Control  
SADE  Serious Adverse Device Effect  
SAE  
Serious adverse event  
SOC 
Standard of care 
STEADI Stopping Elderly Accidents, Deaths, & Injuries 
POA 
Person Of Authority 
UADE  Unanticipated Adverse Device Effect 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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Protocol Synopsis 
Reference ID/Protocol Number: COP-0001 
Title: 
Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult Population with a 
Wearable Smart belt  
Sponsor: 
Active Protective Technologies, Inc 
Regulatory Status:  Non-significant risk pivotal study of medical device 
Objectives:  
Primary Objective: To assess the performance of the Tango® Belt to mitigate fall-related 
major hip injuries in an at-risk of fall adult population as compared to the standard of 
care (SOC) only. 
Secondary Objectives: To assess the performance of the Tango Belt to mitigate falls 
resulting in: (1) hip fractures, (2) emergency department visits or (3) hospitalizations. 
Study Design: Multi-center, comparative, non-significant risk adaptive study with retrospective 
controls. 
After providing informed consent and being screened for eligibility, intervention 
subjects will be prescribed and provided an appropriately sized Tango Belt. The subject 
must demonstrate a minimum of 64% adherence to the use of the Tango Belt within 14 
days of initiation to fully enroll in the study. Upon demonstration of at least minimum 
adherence, the subject will be provided the Tango Belt to wear continuously for at least 
6 months, except during bathing, device charging, and as deemed by clinical staff.  
The study will investigate the safety and effectiveness of the Tango Belt with the 
primary and secondary endpoints being taken every 3 months and at the end of the 
study run time from the electronic medical record. Additionally, ancillary endpoints on 
adverse events and device performance will be gathered.  
Study Population: 
Subjects must be older adults (≥65 years of age) who are at risk for fall with 
major hip-related injury as determined by the SOC for fall-risk management. 
Number of Patients: 
Estimated up to 417 in the treatment group and up to 1688 in the control group.  
Final sample size to be determined from retrospective control data. 
Study Duration: 
Estimated enrollment time 
 
3 months 
 
Estimated in-study run time 
 
6 months 
 
Estimated total duration 
 
12 months after 1st subject enrolled 
 

 
 
 
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Eligibility Criteria 
 
     Inclusion Criteria (ALL of the following criteria): 
 
1. Age 65 years or older; 
2. Have experienced a fall-related fracture after age 50 
-OR- 
Have experienced one or more falls in the 12-months prior to consent and have a diagnosis of 
osteoporosis, osteopenia, or prescribed osteoporosis medication. 
3. Independently or with staff or caregiver assistance, able to transfer between surfaces (e.g., to or 
from a bed, chair, wheelchair, toilet, standing position) or walk or move between locations (use 
of an assistive device such as a walker is acceptable); 
4. Have a waist circumference between 29 – 50 inches (63.5 – 127 cm); 
5. Able to comply with required study procedures and follow-up schedule as determined by the 
Study Investigator;  
6. Are under the care of the Investigational organization; 
7. Provides consent or their legally authorized representative provides consent on subject’s behalf 
 
Exclusion Criteria (ANY of the following criteria): 
 
1. Age 64 years or less; 
2. Participation in a different clinical investigation that can conflict with this clinical study as 
determined by the Study Investigator and approved by the Sponsor; 
3. Total dependence on staff or caregiver assistance to be able to transfer between surfaces (e.g. 
to or from a bed, chair, wheelchair, toilet, standing position) and walk and move between 
locations; 
4. Use of other devices or interventions outside of SOC for fall risk management during study 
participation without Sponsor approval; 
5. Unable to comply with required study procedures and follow-up schedule as determined by the 
Study Investigator; 
6. Does not provide consent, or legally authorized representative does not provide consent 
 
Investigational Device Tango® Belt 
 
Route of Administration The Tango Belt is a device intended to be worn around the waist and is 
designed to: 
− 
Recognize serious hip-impacting falls in progress 
− 
Deploy an airbag upon detection of a serious hip-impacting fall in 
progress to protect the hip region from potential major injury 
− 
Communicate fall and impact alerts to designated persons 
 

 
 
 
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Schedule of Visits 
The study is composed of the following study intervals: 
 
 
 
Baseline 
Enrollment, screening, and provision of Tango Belt 
 
 
 
14-day   
Run-in for adherence screening 
 
 
 
90-days  
EMR screening for endpoints 
 
 
 
180-days 
EMR screening for endpoints and completion of participation 
 
 

 
 
 
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Table of Contents                 
  
 
Title Page  
 
 
 
 
 
 
 
 
 
1 
 
List of Abbreviations and Definition of Terms 
 
 
 
 
 
2 
 
Protocol Summary/Protocol Synopsis 
 
 
 
 
 
 
3 
1. Key Roles 
 
 
 
 
 
 
 
 
 
 
1.1 
Key roles listed  
 
 
 
 
 
 
 
8 
1.2 
Principal Investigator Signature   
 
 
 
 
 
9 
2. Introduction 
2.1. 
Background information  
 
 
 
 
 
 
12 
2.2. 
Scientific Rationale 
 
 
 
 
 
 
 
12   
2.3. 
Prior Investigations and Market Experience 
 
 
 
 
13 
2.4. 
Demonstration of the Safety and Effectiveness of study product  
 
14 
2.5. 
Potential Known Risks and Benefits 
 
 
 
 
 
14 
3. Purpose/Intended Use  
 
 
 
 
 
 
 
14 
4. Study Design, Duration, Objectives and Endpoints 
4.1. 
Study Design 
 
 
 
 
 
 
 
 
15 
4.2. 
Duration 
 
 
 
 
 
 
 
 
15 
4.3. 
Objectives 
 
 
 
 
 
 
 
 
16 
4.4. 
Endpoints 
 
 
 
 
 
 
 
 
16 
5. Selection of Subjects 
5.1. 
Inclusion Criteria 
 
 
 
 
 
 
 
16 
5.2. 
Exclusion Criteria 
 
 
 
 
 
 
 
17 
5.3. 
Strategies for Recruitment and Retention 
 
 
 
 
17 
5.4. 
Participant Withdrawal/Discontinuation or Termination  
 
 
19 
5.5. 
Premature Termination, Suspension, or Extension of Study 
 
 
19 
6. Study Agent/Product 
6.1. 
Device  
 
 
 
 
 
 
 
 
21 
6.2. 
Acquisition 
 
 
 
 
 
 
 
 
21 
6.3. 
Appearance and Labeling 
 
 
 
 
 
 
22 
6.4. 
Product Storage and Stability 
 
 
 
 
 
 
22 
6.5. 
Preparation 
 
 
 
 
 
 
 
 
22 
6.6. 
Device accountability procedures 
 
 
 
 
 
23 
7. Study Procedures and Schedule 
7.1. 
Investigator Training 
 
 
 
 
 
 
 
23 
7.2. 
Laboratory Procedures/Evaluations 
 
 
 
 
 
24 
7.3. 
Study Schedule by visit type 
 
 
 
 
 
 
24 
8. Assessment of Safety 
8.1. 
Definition of Adverse Event (AE) 
 
 
 
 
 
26 
8.2. 
Definition of Serious Adverse Event (SAE) 
 
 
 
 
24 
8.3. 
Classification of AE 
 
 
 
 
 
 
 
27 
8.3.1. 
Severity of event  
 
 
 
 
 
 
27 
8.3.2. 
Relationship to Study Agent/Product 
 
 
 
 
27 
8.3.3.     Adverse Event Report procedures  
 
 
 
 
28 

 
 
 
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8.4. 
Safety Oversight 
 
 
 
 
 
 
 
29 
9. Clinical Monitoring Procedures  
 
 
 
 
 
 
29 
10. Statistical Considerations 
10.1. 
Statistical Sample Size Determination and Analytical Plans 
 
 
30 
10.2. 
Analysis Datasets 
 
 
 
 
 
 
 
32 
10.3. 
Description of Statistical Methods 
 
 
 
 
 
32 
10.4. 
Measures to minimize Bias 
 
 
 
 
 
 
32 
11. Access and Verification of Source Data  
 
 
 
 
 
33 
12. Quality Assurance and Quality Control  
 
 
 
 
 
33 
13. Ethics/Protection of Human Subjects 
 
 
 
 
 
 
 
13.1. 
Ethical Standard 
 
 
 
 
 
 
 
34 
13.2. 
IRB 
 
 
 
 
 
 
 
 
 
34 
13.3. 
ICF Process 
 
 
 
 
 
 
 
 
35 
13.3.1. 
Consent and other informational documents Provided to Participants 
13.3.2. 
Consent Procedures and Documentation 
13.4. 
Participant and Data Confidentiality 
 
 
 
 
 
36 
14. Data Handling and Record Retention 
14.1. 
Data collection and Management Responsibilities 
 
 
 
37 
14.2. 
Study Record Retention  
 
 
 
 
 
 
39 
14.3. 
Protocol Deviations 
 
 
 
 
 
 
 
39 
14.4. 
Publication and Data Sharing Policy 
 
 
 
 
 
39 
15. Investigator Reports 
 
 
 
 
 
 
 
 
40 
16. Termination of Study and Study Site Participation 
 
 
 
 
41 
17. Regulatory Considerations 
 
 
 
 
 
 
 
41 
18. Appendices 
18.1. 
Consent form  
 
 
 
 
 
 
 
42 
18.2. 
Study Questionnaires 
 
 
 
 
 
 
 
54 
18.3. 
Literary References 
 
 
 
 
 
 
 
56 
 
 
Version Information 
 
Revision 
Date 
Description 
1.0 
 28 Jan 2022 
Original Protocol 
2.0 
18Apr2022 
Protocol with simplification of adjudication process noted in 
sections 7.3 and 8.3 iii 
 
 
 
 

 
 
 
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1. 
Key Roles 
1.1  
KEY ROLES  
Sponsor 
Active Protective Technologies, Inc 
580 Virginia Ave 
Suite 230 
Fort Washington, PA 19034 
 
Sponsor Contact 
Rebecca J Tarbert PT, DPT 
Director of Clinical Programs 
Active Protective Technologies, Inc 
580 Virginia Dr 
Suite 230  
Fort Washington, PA 19034 USA 
+1 267 242 6125 
rebecca@activeprotective.com 
 
Medical Monitor 
Richard G. Stefanacci DO, MGH, MBA, AGSF, CMD 
100 Maxis Dr 
Malvern, PA 19355 
+1 610 386 2000 
Richard.stefanacci@jefferson.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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1.2 
Investigator Signature 
 
Study Title: Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult Population with a 
Wearable Smart belt 
 
Reference ID/Protocol#: COP-0001 
Version # & Date: 2.0, April 18, 2022 
 
I have read, understood and agree to:  
 
− 
Ensure that the study is conducted in accordance with this signed agreement, the 
investigational plan and applicable national regulations.  
− 
Ensure that informed consent is obtained prior to entering patients into the study and only 
after required Ethics Committee approvals are obtained;  
− 
Ensure that the requirements for obtaining informed consent are met  
− 
Conduct the trial in accordance with this protocol, including applicable local/state laws and 
regulations  
− 
Adhere to the publication policy of Active Protective Technologies, Inc as stated in the 
Clinical Trial Agreement, for data collected during this trial  
− 
Ensure that all associates, colleagues, and employees assisting in the conduct of the trial 
are informed of their obligations in meeting the above commitments 
− 
Supervise investigational device use and not supply the device to any person not 
authorized to receive it;  
− 
Be accountable for devices under investigation;  
− 
Return to the sponsor any remaining supply of the device upon termination of the 
investigation or my part of the investigation;  
− 
Maintain accurate, complete and current records relating to my participation in the 
investigation;  
− 
Permit inspections by Ethics Committee and national health and/or regulatory agencies;  
− 
Submit complete, accurate and timely reports of:  
o unanticipated adverse events,  
o withdrawal of Ethics Committee approval,  
o deviation from the investigational plan,  
o inability to obtain informed consent, and  
o study progress and completion;  
− 
Comply with any requirements imposed by the reviewing Ethics Committee;  
− 
Discuss the investigational plan and study progress with a representative of Active 
Protective Technologies, Inc. and to permit the representative to inspect all records 
pertinent to the study;  
− 
Obtain written permission from Active Protective Technologies, Inc before publishing or 
presenting information associated with this study;  
− 
Not disclose confidential information regarding this study unless disclosure is required by 
national or other regulations;  

 
 
 
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− 
Inform clinical staff and other persons who have a “need to know” information to 
facilitate the study, that clinical study information is privileged and confidential;  
− 
Not concurrently participate with the clinical evaluation of another wearable hip protection 
product during my period of involvement in this study. 
 
I will ensure that the IRB review complies with governmental requirements and will be 
responsible for the initial and continuing review and approval of the clinical investigation. I also 
agree to promptly report to the IRB all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others. Additionally, I will not make any changes 
in the research without sponsor and IRB approval of an amended protocol, except where 
necessary to eliminate apparent immediate hazards to human subjects. I agree to comply with 
all other requirements of this study in accordance with the protocol, ICH/GCP guidelines, 
applicable local and federal regulations, and to accept respective revisions conducted by the 
sponsor and by regulatory authorities. 
 
 
Principal Investigator (printed):_____________________________________________________ 
 
Principal Investigator signature: ____________________________________________________ 
 
Date: ______________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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2. 
Introduction   
2.1 
Background information 
Every year in the United States there are approximately 3 million fall-related emergency 
room visits for geriatric adults.  Of the 3 million emergency room visits, approximately 
300,000 of those lead to hospital admissions due to hip fracturesi.  This coincides with 
the Centers for Disease Control (CDC) analysis that 1 out of 4 adults over the age of 65 
(i.e., geriatric) will fall each year and those falls may occur more than once in a yearii.  As 
a result of these high numbers, falls are the leading cause of injury-related deaths 
among the geriatric US population and cost over $50 billion in total medical costsiii. 
The standard of care (SOC) in the US for managing the fall risk of geriatric patients is the 
CDC’s Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which 
implements the America and British Geriatric Societies'’ Clinical Practice Guidelines for 
fall risk management. The STEADI algorithm consists of tools and resources for 
healthcare providers for fall risk screening, assessment, and interventioniv,v.  Screening 
and assessment includes identifying fall history and modifiable factors related to fall and 
fall injury risk (e.g. fear of falling, gait, strength, balance, medications, comorbidities, 
etc.); then interventions to reduce the fall and fall injury risk are applied based upon 
assessment findings, and can include physical therapy, medication adjustments, patient 
education, bed and chair alarms, bed rails, etc. vi Healthcare providers have also used 
passive hip protectors as an intervention to mitigate hip fracture for those identified 
with a fall risk.  It has been shown that passive hip protectors are able to reduce hip 
fractures by over 80% when worn during the fallvii,viii.  However, the clinical utility of 
passive hip protectors has been questioned, as compliance of wearing the hip 
protectors has proven to be low due to a variety of factors, most commonly related to 
comfort and difficulty taking them on and off .ix,x 
Despite the broad adoption and utilization of the STEADI algorithm as the SOC for fall 
risk management, the number of older adults experiencing falls and fall related injuries 
has increased or remained unchanged since 2012xi.  Furthermore, per the CDC, fall 
death rates in the U.S. have increased 30% from 2007 to 2026 among older adults.  
Lastly, multiple large clinical trials have recently shown that the aforementioned SOC for 
fall risk management was ultimately unsuccessful in reducing the rate of falls with 
injury. xii, xiii As such, there is a significant unmet need for new interventions for 
geriatric individuals who are at high risk of fall, as the existing SOC is not effective at 
reducing the overall rate of fall injuries.   
 
2.2 
Scientific Rationale   
As a solution to the need for fall injury mitigation, Active Protective Technologies, Inc. 
(“APT”) has developed the Tango® Belt, a wearable device primarily designed to protect 
geriatric individuals against major hip injuries due to a serious hip-impacting fall.  Hip 
injuries are considered major if they are life-threatening, result in hospitalization or 

 
 
 
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emergency care, require medical intervention, or result in disability or permanent 
damage. A fall that results in major hip injury is described herein as a serious hip-
impacting fall.  The Tango Belt uses motion sensors and proprietary algorithms to 
determine if the wearer is experiencing a serious hip-impacting fall in progress and 
automatically deploys an automotive-grade cold-gas airbag around the hips to attenuate 
ground impact forces on the body.  A longitudinal observational study by Yang et. al. 
analyzed recordings from thousands of real-world falls captured on closed-circuit video 
monitoring within the nursing home setting and determined that the vast majority of 
major hip injuries resulted from falls from standing height and ground-force impact to 
the lateral or posterolateral aspect of the hip. xiv  Lastly, as referenced above, a 
randomized clinical trial of over 1200 subjects within nursing homes demonstrated that 
passive hip pads were able to reduce the incidence of hip fracture by over 80% when 
worn during the fall.  These studies provide an evidence-based approach to mitigating 
fall-related major hip injuries via attenuation of ground impact forces and utilizing a 
belt-based form factor specifically designed to overcome common barriers to wear 
compliance.  
 
2.3 
Prior Investigations and Market Experience 
The Tango Belt was previously marketed as a personal safety product and has been used 
in senior care facilities (including Skilled Nursing Facilities, Assisted Living Facilities, and 
Continuing Care Retirement Communities) and in-home environments.  Following 
extensive laboratory testing, a pre-production version of the Tango Belt was initially 
introduced into multiple senior care facilities in a series of pilots beginning in 2017.  The 
production version was then introduced into senior care facilities and in-home 
environments beginning in 2019. To date, the Tango Belt has been worn for over 80,000 
hours of cumulative wear by over 100 older adults within home and senior care settings 
since its introduction as a personal safety product.   
Real-world evidence from this previous use provides insight into the belt’s potential to 
mitigate the injury risk associated with hip-impacting falls.  Published case series 
demonstrated that the belt appropriately detected falls in-progress and could 
discriminate between non-serious and serious hip-impacting falls.  In addition, the belt 
successfully delivered automated fall notifications to designated caregivers when a fall 
occurred. xv  Most notably, unpublished data of real-world evidence demonstrates the 
Tango Belt was able to reduce the overall rate of falls with major injury by 60% over 6 
months in a pilot conducted in a large skilled nursing facility.  Further, the ability of the 
airbag technology to mitigate fall-related injury in a serious hip-impacting fall without 
causing harm to the wearer has been demonstrated.  Lastly, the belt has shown strong 
adherence to wear, with a previously published case series demonstrating that it could 

 
 
 
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be worn comfortably for prolonged durations with wear times exceeding 12 hours and 
with belt removal needed only for charging or for bathing. xvi  
These initial case series demonstrate the utility of the Tango Belt in higher-fall-risk 
patients and warrant further investigation in a controlled study to specifically establish 
the safety and effectiveness of the Tango Belt for the mitigation of falls with major hip-
related injury in an at-risk, older adult population. 
 
 
2.4 
Demonstration of the Safety and Effectiveness of study product 
Laboratory performance testing of the serious hip-impacting fall-in-progress detection 
algorithm was conducted using APT’s staged true-fall library and demonstrated 
sensitivity of 82%. This testing includes inertial data sensor recording, prototype sensor 
and airbag-disabled belt assemblies, and pre-production sensor and airbag-disables belt 
assemblies. Further, with respect to specificity, there were 10 false positives (i.e., false 
alarms) over 66,000 wear-hours.  Laboratory testing includes extensive design 
verification testing to confirm safety and functionality of the hardware and software, 
including impact attenuation on crash test dummies, environment conditioning, out-of-
position deployment, FCC certification, electromagnetic emissions and immunity, belt 
and companion app usability, etc.  In conjunction with the real-world evidence noted 
above, testing performed to date has demonstrated that the Tango Belt is safe and 
performs as intended. 
 
2.5 
Potential Known Risks and Benefits 
Risks to subjects in this study include, but are not limited to, the following: use error or 
ineffective intervention leading to impact-related injury, adverse tissue reactions and 
interference with other electrical equipment/devices.  
Presently, there are no known adverse events associated with the Tango Belt itself that 
have arisen throughout the pre-clinical testing and real-world usage. 
Potential benefits of the Tango Belt include mitigating major hip injuries due to falls and 
reducing emergency department visits and hospitalizations due to falls, thereby 
enabling safer mobility in older adults at risk of falls and fall injuries. 
 
3. 
Purpose/Intended Use 
Purpose: 
The current comparative clinical study is intended to establish the safety and effectiveness of 
the Tango Belt as an adjunctive intervention to the standard-of-care (SOC) to mitigate major hip 
injuries due to falls in an older adult population at-risk for fall injury. 

 
 
 
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Intended Use: 
The Tango Belt is intended to be worn around the waist by geriatric individuals (65+ years of 
age) at risk for fall injury in order to mitigate major hip injuries related to falls.  The Tango Belt 
uses built-in sensors and algorithms to detect falls and impacts.  The device can send an alert to 
the designated caregiver/healthcare providers upon detection of a fall or impact.  When an in-
progress serious hip-impacting fall is detected, an airbag will deploy to physically protect the hip 
region from potential major injury.  The Tango Belt is for prescription use only. 
 
4. 
Study Design, Duration, Objectives and Endpoints 
 
4.1 
Study Design 
This is a multi-center, comparative, adaptive, non-significant risk clinical trial conducted 
in the United States to assess the safety and efficacy of the Tango Belt within senior care 
settings. Effectiveness of the Tango Belt will be determined by analysis of evidence for 
the Tango Belt as an adjunctive intervention to the standard-of-care (SOC) to mitigate 
major hip injuries from falls in an older adult population at-risk for fall injury as the 
primary endpoint. Performance of the Tango Belt to mitigate fall injuries that result in 
hip fracture, emergency room visits, and hospitalizations will be secondary endpoints. 
The performance of the device is determined by the comparison of the proportion of 
fall-related major hip injuries in the intervention group as compared to the proportion 
of fall-related major hip injuries in a retrospective control group utilizing only SOC. SOC 
utilization will be verified for each clinical site enrolled. An adaptive trial design will be 
utilized to allow an initial efficacy target to be evaluated at 6 months; if the initial target 
is not met, then a second cohort of sites and subjects will be enrolled for an additional 6 
months to allow a lower efficacy target to be evaluated. 
Safety of the device will be determined by analysis of adverse events as an ancillary 
endpoint.  
 
4.2 
Duration (per site) 
Estimated enrollment time 
 
3 months 
Estimated in-study run time 
 
6 months 
Estimated total duration 
 
12 months after 1st patient enrolled 
 
 
 
 
 

 
 
 
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4.3 
Objectives 
Primary Objective: To assess the performance of the Tango Belt to mitigate fall-related 
major hip injuries in an at-risk of fall adult population as compared SOC only. 
Secondary Objective: To assess the performance of the Tango Belt to mitigate falls 
resulting in: (1) hip fractures, (2) emergency department visits or (3) hospitalizations. 
 
 
4.4  
Endpoints 
Primary Endpoint: The primary outcome measure will be the proportion of major hip 
injuries due to fall in the subjects receiving SOC as compared to subjects receiving SOC 
plus the Tango Belt.   
Secondary Endpoints: Secondary outcome measures include the proportion of each of 
the following: 
− 
Hip fractures due to fall in the subjects receiving SOC as compared to subjects 
receiving SOC plus the Tango Belt.   
− 
Emergency Department visits due to fall in the subjects receiving SOC as 
compared to subjects receiving SOC plus the Tango Belt.   
− 
Hospitalizations due to fall in the subjects receiving SOC as compared to 
subjects receiving SOC plus the Tango Belt.   
Ancillary Endpoints: Ancillary endpoints will include: 
− 
Adverse events 
− 
Major injuries due to fall 
− 
Fall occurrence 
− 
Device wear adherence 
− 
Device fall alerts 
− 
Device discrimination of serious hip-impacting vs. non-serious hip and non-hip 
impacting falls 
− 
Airbag deployment 
− 
FES-I short version  
 
5. 
Selection of Subjects 
 
5.1  
Inclusion Criteria:  All subjects are required to meet ALL of the following inclusion 
criteria to be considered eligible for participation in this study: 
 
1. 
Age 65 years or older; 

 
 
 
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2. 
Have experienced a fall-related fracture after age 50 
-OR- 
Have experienced one or more falls in the 12-months prior to consent and 
have a diagnosis of osteoporosis, osteopenia, or prescribed osteoporosis 
medication. 
3. 
Independently or with staff or caregiver assistance, able to transfer between 
surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing position) or 
walk or move between locations (use of an assistive device such as a walker is 
acceptable); 
4. 
Have a waist circumference between 29 – 50 inches (63.5 – 127 cm); 
5. 
Able to comply with required study procedures and follow-up schedule as 
determined by the Study Investigator;  
6. 
Are under the care of the Investigational organization; 
7. 
Provides consent or their legally authorized representative provides consent on 
subject’s behalf 
 
5.2  
Exclusion Criteria: Subjects will be excluded from participating in this study if they 
meet ANY of the following exclusion criteria: 
 
1. 
Age 64 years or less; 
2. 
Participation in a different clinical investigation that can conflict with this clinical 
study as determined by the Study Investigator and approved by the Sponsor; 
3. 
Total dependence on staff or caregiver assistance to be able to transfer 
between surfaces (e.g., to or from a bed, chair, wheelchair, toilet, standing 
position) and walk and move between locations; 
4. 
Use of other devices or interventions outside of SOC for fall risk management 
during study participation without Sponsor approval; 
5. 
Unable to comply with required study procedures and follow-up schedule as 
determined by the Study Investigator; 
6. 
Does not provide consent, or legally authorized representative does not provide 
consent 
 
5.3  
Strategies for Recruitment and Retention 
Control group: The investigator or designee will retrospectively review the site's EMR 
database to determine their long-term care patient population's initial eligibility for 
meeting the study inclusion criteria. The subjects in the clinical site census at the time 
frame 6 months prior to the IRB approval date will be screened for eligibility for study 
inclusion. Subjects eligible for the control group must meet the requirements of the 
inclusion and exclusion criteria except for the waist circumference and need for consent. 
Eligible subjects’ electronic health records will be mined for the baseline, midpoint, and 

 
 
 
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final study metrics. If there is an insufficient number of eligible subjects to meet the 
control group target (defined as 4 times the expected number of intervention group 
subjects to be enrolled from the site) at 6 months prior to the intervention group start 
date, the EMR database screen will extend retrospectively in 6 month increments until 
the control group target is reached.  
 
Intervention group: The investigator or designee will review the site's EMR database to 
determine their current long-term care patient population’s initial eligibility for meeting 
all study inclusion and exclusion criteria, except for waist circumference, informed 
consent, and ability to comply. Subjects meeting initial eligibility will then have their 
waist circumference obtained, and those that meet inclusion criteria will then be 
offered the opportunity to participate in the study through the informed consent 
process utilizing IRB approved subject facing recruitment materials including a video 
introduction of the device, a flyer on the device and research study and verbal 
explanation of the study with access to study site investigator for addressing questions 
and/or concerns. If the subject agrees to be a participant in the study, the subject will be 
given a written informed consent to read, sign and date (Appendix 1 - Informed 
Consent). If the subject has a Legally Authorized Representative (LAR) or Person of 
Authority (POA) in place, the POA will receive notification regarding the eligibility for the 
subject to participate in the study with the IRB approved subject facing recruitment 
materials including video introduction of the device, a flyer on the device and research 
study and verbal explanation of the study with access to study site investigator for 
addressing questions and/or concerns with the written informed consent. The POA may 
offer consent verbally over the phone to the investigator/ designee with notation on the 
Informed Consent Form and subsequent receival of copy of the ICF via USPS or email. 
The ICF can also be signed electronically with a provided eSignature option to the POA. 
All subjects or POAs will be given the opportunity to discuss the technology, risks, 
potential benefits, alternative therapies, and the study requirements with the 
investigator prior to signing the informed consent. Subjects or their POAs that provide 
written or electronic consent will be preliminarily enrolled into the intervention group. 
Upon preliminary enrollment, utilization of the Tango Belt will be prescribed by the 
site's physician and written into the subjects’ plan of care at the care residence. A Tango 
Belt of appropriate size based upon waist measurement will be provided to the subject 
by the investigator or designee. The subject will be assigned to the Tango Belt ID located 
in the APT cloud electronically via Tango Belt companion app for data tracking. The 
Tango Belt size will be adjusted for most comfortable and appropriate fit using the sizing 
strap located in the left side zipper pocket of the Tango Belt. The Tango Belt will be 
prescribed to be worn up to 24 hours/ day with removal for bathing activities, dressing 
as needed, twice a week at minimum for charging and upon subject request. Baseline 
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assessed for cognition level via the BIMS if this has not already been taken as part of the 
EMR. Assessment of balance confidence using the short version of the FES-I if they are 
cognitively capable of completing the survey with a BIMS Score of 13-15.  (Appendix 2 –
Study Questionnaire)  
Enrolled subjects in the intervention group will then proceed through a run-in period of 
14 days to assess adherence to utilization of the Tango Belt. At 14 days, if the subject is 
demonstrating adherence to use of the device of at least 64% as viewed by the 
investigator or designee in the Tango Belt companion app dashboard as “Compliance” 
(defined as wearing the device for at least 1 hour per day for at least 9 of 14 days), they 
will be fully enrolled into the study and proceed through the study duration.  Subjects 
who do not meet the run-in period requirement will be withdrawn from the study.  
Screen Failures in this study would include study candidates that: 
 
• 
Do not meet inclusion criteria 
• 
Meet any exclusion criteria 
• 
Do not fit within the range of Tango Belt sizing available 
• 
Do not comply with the minimum device utilization of 64% within the run-in 
period 
To account for the relatively high morbidity and mortality of the target study 
population, we will assume a 20% in-study attrition rate, and thus will aim to over-
recruit by this amount beyond the target sample size statistically required for the 
intervention group. 
Lastly, after 6 months of in-study participation, intervention subjects may be given the 
option to continue wear of the Tango Belt in order to collect longer-term safety and 
efficacy data.  In an effort to minimize potential for bias, this option will not be revealed 
to intervention subjects prior to study enrollment. 
 
5.4  
Participant Withdrawal/Discontinuation or Termination 
All subjects will be followed for 6 months following enrollment in the study to ensure 
study inclusion and exclusion criteria continue to be met; any subject who no longer 
meets the study criteria during this timeframe will be withdrawn.  Intervention subjects 
will be advised that they may voluntarily withdraw from the study at any time without 
jeopardy to any future medical care and will be instructed to notify the investigator or 
designee immediately should they wish to do so.  If any intervention subject wishes to 
withdraw from the study, the reason(s) for discontinuation will be recorded in the 
subject's chart and on the appropriate Case Report Form (CRF). Intervention subjects 

 
 
 
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may choose to withdraw for any reason and are not obligated to reveal their reason(s) 
for withdrawal.  
Any screen failure, withdrawal/discontinuation or termination of a subject from the 
study will be accompanied by the date, the reasoning specific to the removal from study 
and data captured prior to removal will be recorded on the CRF.  
If a significant symptom or adverse event is associated with discontinuation, this will be 
recorded in the CRF and patients who are withdrawn due to adverse events will be 
followed until resolution or stabilization of the adverse event. 
If an intervention subject is demonstrating adherence to utilization of the device under 
64% during the initial 14-day run-in period, they will be withdrawn from the study. 
It is also recognized that the investigator, at his or her discretion, may withdraw a 
subject from this trial to pursue other treatment modalities, if the subject no longer 
meets the study inclusion and exclusion criteria, or if the subject cannot continue in the 
trial for any medical reason(s). The sponsor is to be notified in a timely manner if the 
subject is to be withdrawn and a Study Termination Form will be completed. 
 
5.5  
Premature Termination, Suspension, or Extension of Study 
It is agreed that either the investigator and/or APT may terminate this study at any time, 
provided written notice is submitted at a reasonable time in advance of intended 
termination. The study may be extended to obtain expanded efficacy and safety 
information as per the adaptive trial design and/or to obtain long-term safety 
information. Also, a decision on the part of the IRB/EC to suspend or discontinue testing, 
evaluation, or development of the product may lead to discontinuation/termination of a 
study subject’s participation.  
A study conducted at a single study site in a multicenter study may also warrant 
termination under the following conditions:  
- 
Failure of the Investigator to enroll patients into the study at an acceptable rate  
- 
Failure of the Investigator to comply with pertinent regulations of appropriate 
regulatory authorities  
- 
Insufficient adherence to protocol requirements  
- 
Submission of knowingly false information from the research facility to the sponsor, 
study monitor, or appropriate regulatory authority 
 
6.  
Study Agent/Product 
 

 
 
 
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6.1 
Device 
The Tango Belt (the “Device”) is a wearable belt designed to enable safer mobility of 
geriatric individuals (≥ 65 years of age) at risk for fall injury by mitigating major hip 
injuries due to falls. The Tango Belt is a patient-contacting electronic device made out of 
medical grade plastics and biocompatible fabrics.  It is worn around the waist at the iliac 
crest, secured by a buckle.  It comes in 5 sizes, XS, S, M, L, and XL, to accommodate 
wearers with a waist circumference between 29-50 inches (covering the 5th-95th 
percentile of older adults in the US); each belt is further adjustable to prevent sliding 
past the hips or elevating out of position.  
The Tango Belt contains a fall-in-progress detection algorithm which can detect a 
serious hip-impacting fall-in-progress using built-in sensors and deploy an automotive-
grade cold-gas airbag to protect the hips from ground impact forces. When connected 
to Wi-Fi, the Tango Belt can send automated fall and impact alerts to caregivers and 
Healthcare Providers (HCPs) while recording motion and event data, which can then be 
analyzed for usage-based metrics viewable via a companion mobile app and/or desktop 
app. The Tango Belt can also send manually activated alerts for help, triggered by 
pressing a button on the belt buckle, when connected to Wi-Fi. Alerts are sent in the 
form of SMS texts and emails to alert recipients designated in the mobile or desktop 
Companion App. The Tango Belt can also detect non-serious hip-impacting or non-hip 
impacting falls in which the wearer may have incurred a minor injury (i.e., not a major 
hip injury) and/or may be unable to get up.  
Additionally, the belt can be periodically surface disinfected using a germicidal wipe.  
Further, the belt contains a non-replaceable lithium-ion battery, which requires 
recharging via the included specially designed AC adapter every several days depending 
on wear duration.  An optional Safety Latch can be installed by care staff on any belt to 
prevent inadvertent unbuckling.  Lastly, if airbag deployment occurs, the Tango Belt 
cannot be reused. 
The Tango Belt’s Companion App (available in mobile and desktop versions) enables the 
following added functionality: 1) connecting the belt to Wi-Fi (mobile version only), 2) 
inputting contact information for alert recipients, 3) viewing dashboard metrics (e.g. 
Compliance and Daily Wear), 4) taking or administering the FES-I survey, and 5) 
managing a fleet of multiple belts within a facility setting. 
 
6.2 
Acquisition 
The sponsor will provide the Tango Belts in numbers allocated to the sizes appropriate 
for enrolled subjects in the intervention group. The Tango Belts will be delivered to the 
clinical sites with chargers, instructional materials, and cleaning materials during the 
time of EMR screening in preparation for enrollment. Extra Tango Belts will be provided 

 
 
 
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to all clinical sites in sizes allocated for replacement in the case of device malfunction or 
airbag deployment.  
 
 
6.3 
Appearance and Labeling 
The main component of the Tango Belt is the belt itself, which is shipped and stored in a 
custom foam-padded cardboard box also containing the Tango Belt Product Guide and 
Tango Belt charger.  Each Tango Belt, including its individual box, is clearly labeled with 
its size and unique Serial Number (aka “ID number”), which is number located on the 
inside of the right zipper pouch and is uniquely tied to its lot manufacturing record and 
any digital data stored in the APT cloud.  Physical labeling on the belt also includes 
graphical symbols to aid proper donning, warnings, and contact information.  Further, 
the Product Guide includes instructions for use, warnings, cautions, and useful tips for 
operation.  The Support page of the Tango Belt website also includes instructional 
videos covering the operation of the belt and companion app, as well as useful tips and 
cautions. 
 
 
6.4 
Product Storage and Stability 
Tango Belt is designed to be shelf-stable for at least 12 months, in package, in climate-
controlled storage. The Tango Belt should not be exposed to temperatures outside the 
range of -4° to 122° F (-20° to 50° C).   If stored unused for a long period of time the belt 
should be recharged prior to use. For purposes of this clinical trial, no other special 
storage instructions apply.  Product usage life of the Tango Belt is 3 years from the date 
of first use.   
 
 
6.5 
Preparation 
The Tango Belt must be properly sized to the waist of each intervention subject.  
Determination of proper belt size and further adjustment of the built-in sizing strap is 
described in the Product Guide and online training videos.  Prior to use, the Tango Belt 
should be charged using the included charger; charging time requires approximately 3 
hours when the battery is fully depleted.   
Additionally, the Tango Belt Companion App (running on a compatible mobile device) 
must be used to complete the following preparation steps prior to first use: 
− 
Each belt must be connected to the site’s Wi-Fi network using the Guided Setup  

 
 
 
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− 
A new “Wearer” should be created for each intervention and given a wearer 
name consistent with the subject naming scheme for the study 
− 
Lastly, the sized belt should be ASSIGNED to the newly created Wearer via its 
unique Serial Number located on the belt and package labeling 
Upon completion of the steps above, the Tango Belt can then be provided to the 
intervention subject to begin their 6-month study participation (subject to successful 
completion of their 14-day run-in period). 
 
6.6 
Device accountability procedures 
An electronic data capture (EDC) platform will be custom-developed for this study and 
utilized by investigators or designees at each site for the purposes of electronically 
collecting and managing CRF data throughout the study.  For each intervention subject, 
the investigator or designee will enter into the EDC platform the Tango Belt ID number 
along with a unique subject identifier obtained from APT to enable matching of EDC 
data with data stored in APT’s cloud.  
Labels will be provided for marking room numbers on the external aspect of the Tango 
Belt for easy identification of subject assigned device. 
Inventory tracker sheets will be provided for quick reference of care team members and 
study investigators on-site for device allocation.  
Lastly, metal rolling carts will be provided to each site to allow for secure storage and 
charging of belts provided for this study. 
 
7. 
Study Procedures and Schedule 
 
7.1 
Investigator Training 
All investigators involved in the clinical study will attend to the following training: 
− 
Good Clinical Practices (GCP) and Research Ethics Training by an approved 
provider. Attendance certificates will be held at the clinical study sites 
− 
Electronic Documentation System for recording of all data required on the CRF per 
this protocol 
− 
Use and care of the Tango Belt 
− 
Use of the Tango Belt mobile and desktop apps as appropriate 
 
 
 

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7.2 
Evaluations and Scheduled Data Collection Flow Chart 
Evaluation 
Visit 1 
Screening/ 
Baseline Visit 
(+/- 14 days) 
Visit 2 
14-day Run-In
(+/- 2 days)
Visit 3 
90-Days
(+/- 10 days) 
End of Study 
180-days
(+/- 30 days) 
Unscheduled 
Visit / 
Render Informed 
Consent 
X 
Demographic 
information 
X 
Medical / Fall history 
X 
BIMS 
X 
Fall mitigation plan 
of care 
X 
X 
X 
X 
FES-I (short version) 
X 
X 
X 
X 
Inclusion/Exclusion 
criteria review 
X 
X 
X 
X 
Tango Belt 
adherence 
X 
X 
X 
X 
Adverse Events 
(including Fall event 
information) 
X 
X 
X 
Device deficiencies 
X 
X 
X 
7.3   Study Visit Descriptions
Visit 1 Baseline: 
•
Informed Consent will include the provision of the Informed Consent Form (ICF) with
overview of the clinical study proposed and informational materials that may include:  video
description, flyer and discussion of the Tango Belt technology. Informed consent will be
obtained in person by qualified clinical study site personnel delegated to this task by the site
investigator and before any study related procedures and/or assessments can be
performed.  If the subject has a legally authorized representative (LAR) documented as a
person of authority (POA), that person identified in the EMR will be contacted with the same
information and presented with the ICF. If there is telephonic agreement of study consent,
this will be noted by the CRA on the ICF with date, time and indication of LAR, with tow (2)

 
 
 
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copies sent via email or USPS to the LAR for final signature. An email including the ICF with 
explanation of the clinical study and inclusion of the noted information can also be shared 
with a LAR for electronic signature for subject informed consent. Contact information for 
the clinical site study investigator will be provided to the subject/LAR to offer 
communication in regard to any questions or concerns for consenting to participation in the 
clinical study. The subject will be provided the Short version of the FES-I if they have the 
cognitive capability to do so. BIMS score of 13-15 indicates ability to take the Short version 
of the FES-I.  
• 
The subject will be assigned a Tango Belt of the correct size based on measuring their waist 
size and the belt will be introduced to the subject with specific fitting applied using the 
sizing strap for best comfort. The Tango Belt assignment will be performed using the Tango 
Belt Companion App to allow for data tracking for this subject. An order for wearing of the 
Tango Belt will be applied to the medical chart and the care team will be notified of the 
patient’s inclusion in the study with attention for wear adherence and charging cycle. 
• 
The baseline metrics of medical and fall history, fall mitigation plan, and mobility level will 
be taken directly from the MDS and/or EMR within the electronic documentation system 
utilized at the clinical study site.  
 
Visit 2 Run-in period (14 days +/- 2): 
• 
Metrics of the compliance to wear of the Tango Belt by the subject defined as at 
minimum 64% (at least 1 hour a day for 9 days out of 14) will be provided by sponsor to 
the CRA. If the subject is not utilizing the device for at least the minimum amount of 
time, they will be determined to be a screen failure and withdrawn.  
 
Visit 3 Midterm (90 days +/- 10): 
• 
Metrics of changes in fall mitigation plan, mobility level and fall events including falls, 
falls with major injury, adverse events (whether not pertaining to the Tango Belt), 
emergency department visits, and hospital admissions will be taken by the site -
investigator or designee research assistant directly from the MDS and/or EMR within 
the electronic documentation system utilized at the clinical study site. 
• 
Metrics of Tango belt wear days and wear hours/day will be provided to the site 
investigator or designee research assistant from the sponsor or obtained from the 
Tango Belt Companion App.  
• 
Metrics of device deficiencies, device discrimination between types of falls, airbag 
deployments, and alerting will be provided to the site investigator or designee research 
assistant by sponsor from the Tango Belt cloud. 
 
 
 
End of Study (180 days +/- 30): 
• 
Metrics of changes in fall mitigation plan, mobility level and fall events including falls, 
falls with major injury, adverse events (whether or not pertaining to the Tango Belt), 
emergency department visits, and hospital admissions will be taken by the site -

 
 
 
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investigator or designee research assistant directly from the MDS and/or EMR within 
the electronic documentation system utilized at the clinical study site. 
• 
Metrics of Tango belt wear days and wear hours/day will be provided to the site 
investigator or designee research assistant by sponsor or obtained from the Tango Belt 
Companion App.  
• 
Metrics of device deficiencies, device discrimination between types of falls, airbag 
deployments, and alerting will be provided to the site investigator or designee research 
assistant by sponsor from the Tango Belt cloud. 
• 
Tango Belt will be collected by the sponsor for return to Active Protective Technologies, 
Inc.  
 
 
 
Unscheduled Visit (AE, hospitalization, change in status in medical care plan): 
• 
Metrics of changes in fall mitigation plan, mobility level and fall events including falls, 
falls with major injury, adverse events (whether or not pertaining to the Tango Belt), 
emergency department visits, and hospital admissions will be taken by the site 
investigator or designee research assistant directly from the MDS and/or EMR within 
the electronic documentation system utilized at the clinical study site. 
• 
Metrics of Tango belt wear days and wear hours/day will be provided to the site 
investigator or designee by sponsor or obtained from the Tango Belt Companion App.  
• 
Metrics of device deficiencies, device discrimination between types of falls, airbag 
deployments, and alerting will be provided to the site Investigator or designee research 
assistant by sponsor from the Tango Belt cloud 
 
Major Hip Injury Adjudication: for 90-day and 180-day adverse event reporting of Fall with 
Major Injury: 
• 
In the event of an identified Fall with Major Injury, the determination of Fall with Major 
Hip Injury will be independently assessed by a qualified medical expert in the field of 
geriatric medicine after receiving blinded data regarding the injury.  
 
8. 
Assessment of Safety 
8.1  
Definition of Adverse Event (AE) 
An Adverse Event (AE) is defined as:  
Any untoward medical occurrences in a patient or subject receiving an investigational 
medical device and does not necessarily have to have a causal relationship with the 
device under investigation. An AE can therefore be any unfavorable and unintended sign 
(including abnormal laboratory finding), symptom, or disease temporally associated 
with the use of a medical device whether or not considered related to the medical 

 
 
 
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device. Any fall event is considered an AE for this study.  
 
8.2   
Definition of Serious Adverse Event (SAE) 
A Serious Adverse Event (SAE) is defined as:  
An AE that results in any of the following outcomes:  
− 
Results in death;  
− 
Is life-threatening;  
− 
Requires in-patient hospitalization or prolongation of existing hospitalization;  
− 
Results in persistent or significant disability/incapacity 
 
8.3  
Classification of AE 
i.    
Severity of event 
Each AE must be described as follows: 
▪ 
the date of onset;  
▪ 
date of resolution;  
▪ 
severity;  
▪ 
frequency of the event (single episode, intermittent, continuous);  
▪ 
action taken (none, medical and/or surgical);  
▪ 
relationship to study device; 
▪ 
seriousness criteria must be recorded. 
Each adverse event must be recorded separately.  
AE Severity will be assessed using the following definitions:  
Mild 
 
 Aware of sign or symptom, but easily tolerated  
Moderate 
 Discomfort enough to cause interference with usual activity  
Severe  
 Incapacitating with inability to work or do usual activity  
 
ii. 
Relationship to Study Agent/Product 
The relationship to study device will be assessed by the site investigator using 
the following definitions:  
Not Related  
Evidence exists that the adverse event definitely has a cause 
other than the study device (e.g., pre-existing condition or 
underlying disease, intercurrent illness, or concomitant 
medication) and does not meet any other criteria listed.  

 
 
 
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Possibly Related  
A temporal relationship exists between the event onset and 
administration of study device. Although the adverse event 
may appear unlikely to be related to the study device, it 
cannot be ruled out with certainty, and/or the event cannot 
be readily explained by the patient’s clinical state or 
concomitant therapies.  
Probably Related 
A temporal relationship exists between the event onset and 
administration of study device and appears with some 
degree of certainty to be related based on known 
mechanism of action of the device. It cannot be readily 
explained by the patient’s clinical state or concomitant 
therapies.  
Definitely Related  Strong evidence exists that the study device caused the 
adverse event. There is a temporal relationship between 
the event onset and administration of the study device. 
There is strong mechanistic evidence that the event was 
caused by the study device. The patient’s clinical state and 
concomitant therapies have been ruled out as a cause. 
 
Adverse events related to the Tango Belt could include the following: 
− 
Discomfort, soreness, or injury due to normal wear of the belt, 
particularly in subjects who are very frail and thin and/or when the belt 
is not properly sized or fitted to the subject 
− 
Discomfort, soreness, or injury caused by airbag deployment 
 
iii. 
Adverse Event Reporting Procedures 
Apparent Device malfunctions can be troubleshooted by site staff following 
provided materials, or by contacting sponsor for support, and should be 
recorded in patient files, along with initial date of occurrence, brief description, 
did it cause adverse events, whether damage is apparent.  Malfunctions that 
impact essential performance, as defined in the Instructions for Use, should be 
recorded immediately and reported immediately to site-investigator.  The site 
investigator may seek additional support from sponsor, but records in the EDC 
when a device is replaced due to malfunction, with date of replacement and 
start of malfunction.  A device that doesn’t maintain essential performance, as 
defined in the Instructions for Use, should be replaced (e.g. fails to power on, 
deploys without a fall, solid red light, blinking blue light).  The site shall 
coordinate with the Sponsor Monitor for return and replacement, as needed. 

 
 
 
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All adverse events are to be evaluated for severity, relationship to product and 
whether they constitute an SAE, recorded in the EDC, to be reviewed by PI as 
described in section 8.4.  PI continually monitors the enrolled study subjects for 
AEs and possible SAEs in the medical record.   
PI should be notified immediately upon, Serious Adverse Event, fall event, or an 
AE that impacts utilization of the device. 
Serious Adverse Events (SAE’s) including status changes indicated in study 
subject medical records receive immediate attention of the Principal 
Investigator (PI) for consideration of device-related SAE.  Serious AE (SAE) are to 
be reported to Sponsor and the IRB within 24 hours of the site becoming aware 
of the event.  SAE notifications to the Sponsor are to be reported and 
completed via EDC. 
Upon a fall event, site investigator is to initiate a Fall report, to gather evidence 
needed for the eventual adjudication of the Adverse Event, if required.  Falls 
with Major Injury will be reviewed by the medical expert adjudicator as outlined 
in section 7.3. (Note, a Fall with Major Injury could also be considered a SAE for 
purposes of IRB reporting). 
 
8.4 
Safety Oversight 
This trial is not conducted in an emergency setting and informed consent is 
being collected, so a Data Monitoring Committee is not required under 
regulation.  The device poses non-significant risk and has been observed in a 
real-world setting (see section 2.3).   
The Medical Monitor and Principal Investigator will oversee the safety of the 
study including any AEs and SAEs reported by the clinical Investigative Sites. 
Notification of any AEs will be obtained by the Principal Investigator via 
reporting from clinical site investigators in the shared CRO EDC system. 
Adverse Events (AEs) that occur will be captured in the 90-day and 180-day visit 
reporting in the EDC for PI review. 
 
9. 
Clinical Monitoring Procedures 
Monitoring will be conducted by Sponsor and/or designee to ensure investigator and site 
personnel are in compliance with: 
 

 
 
 
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• 
The signed Clinical Trial Agreement, 
• 
This Study Protocol, 
• 
Adherence to applicable FDA regulations, 
• 
Any conditions of approval imposed by the IRB or FDA, 
• 
Ensuring the rights and well-being of the subjects are protected, 
• 
Ensuring the reported study data are accurate, complete, and verifiable from source 
documents, and 
• 
Ensuring the conduct of the study is in compliance with Good Clinical Practice. 
 
Subject CRFs will be electronically completed and reviewed for completeness and accuracy as 
well as for any evidence suggesting subject risk. Risk can be anything that can affect subject 
safety and can be many factors including but not limited to: the reporting of false or inaccurate 
data, study visits and/or study procedures not being performed as required per protocol, 
misconduct or non-compliance by subject and/or site staff, and anything that can potentially 
harm or cause discomfort to the subject. Where any discrepancies are noted, they will be 
resolved with the investigator and/or an individual designated by the investigator. When the 
data are incomplete, attempts will be made to obtain the missing data. 
 
Monitoring procedures and frequency will be conducted throughout the course of this study 
according to the Clinical Monitoring Plan. Monitoring visits will focus on the status of regulatory 
documents, adherence to the protocol, review of informed consents, adverse event reporting, 
device accountability, and a comparison of source documentation against electronic case report 
forms (eCRFs). Qualified site study personnel are expected to spend some time with the clinical  
monitor to resolve queries and review action items at each onsite monitoring visit. 
 
The investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB review, and 
regulatory inspection(s), providing direct access to source data/documents. 
 
Representatives of the sponsor may request access to all study records, including source 
documents, for inspection and copying during normal business hours.  
 
10. 
Statistical Considerations 
10.1 
Statistical Sample Size Determination and Analytical Plans 
Historical control data will be utilized from data available in the medical record. 
Specifically, the rate of falls with major injury will be obtained and analyzed in 6-month 
retrospective periods from Investigational sites participating in the prospective 
enrollment of treatment subjects, beginning with the IRB approval date and extending 
back to 2018. Due to the COVID-19 pandemic restrictions, it is possible that some 
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period. Therefore, if there is any evidence that the rate of falls resulting in major injuries 
is different for any portion of the 2018–present time frame, historical control data will 
not be utilized from the time frames with a different fall rate. The sample size for the 
control group, and therefore the allocation ratio, will be determined by the number of 
historical controls for which data is available during the selected time periods. It is 
anticipated that control data will be available to allow 2, 3, or 4 controls for each 
treatment subject. The annual rate of falls with major hip injury has been estimated 
between 6% and 10% in higher-risk populations within long-term care facilities. Since 
the fall rate is not exactly known in the study population, the fall rate observed in the 
historical control group, a nuisance parameter, will be used for sample size calculations. 
To estimate performance of the Tango Belt, data on file from real-world use of the 
Tango Belt in the nursing home setting found airbag deployment in 6 of 6 total serious 
hip-impacting falls, resulting in no major hip injuries. Therefore, we are 95% confident 
that the Tango Belt will protect 66% of falls. However, it is possible that the Tango Belt 
may prove to be even more effective with a larger sample size. Therefore, a group 
sequential design (GSD) will be utilized. The GSD will include a planned interim analysis 
at a sample size to detect an 80% protective effect of the Tango belt at 80% power at a 
planned interim analysis. If a significant difference is found between the prospective 
Tango Belt subjects and historical controls at the interim analysis, the study will be 
completed early. If not, enrollment will continue until a final sample size is reached to 
detect a 60% protective effect of the Tango belt at 80% power and a 5% total level of 
significance. Exact sample sizes for the interim and final analysis will be calculated once 
the number of historical control subjects and the rate of falls with major hip injury in the 
control group are determined. The PASS GSD module will be used to simulate the 
sample sizes and power using the Pocock alpha-spending function. The steps to 
calculate the sample size will include: 
1. 
Test the historical control time periods to determine if all the time periods can 
be used, depending on if any time periods differ in fall rate 
2. 
From the remaining historical control data, find the fall rate and the total 
sample size available for the historical control group 
3. 
Find the sample sizes for the historical controls and the prospective Tango Belt 
arm at the interim analysis.  
4. 
Find the sample size for the prospective Tango Belt arm at the final analysis; the 
total sample of historical controls will be used at this look. 
To demonstrate these calculations, we assumed subjects were followed for an average 
of 6 months, an annual fall-with-major-hip-injury rate of 8%, and sufficient historical 
control subjects to allow 1:4 allocation of subjects to treatment and control. This would 
require 176 subjects in the prospective Tango belt group and 704 subjects in the 
historical control group at the interim analysis. At the end of the study (should the 

 
 
 
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higher efficacy target not be achieved at interim analysis), 417 total subjects would be 
required in the prospective Tango belt group and 1688 subjects would be in the 
historical control group.  
 
10.2 
Analysis Datasets 
Datasets to be used in the analysis include: 
− 
EMR database of long-term care patient population at each site  
− 
In-study CRF data collected within the EDC platform for intervention subjects 
− 
Dashboard metrics (Compliance and Daily Wear) and alert data collected 
automatically by belts in the APT Cloud for intervention subjects 
− 
FES-I data collected via Companion App for intervention subjects 
 
 
10.3 
Description of Statistical Methods 
A test of proportions will be used to test the primary hypothesis that the proportion of 
subjects experiencing major hip injuries due to falls is lower in subjects receiving SOC 
plus the Tango Belt than in subjects receiving SOC alone, adjusting for propensity score. 
The hypotheses for the secondary endpoints will also be tested using propensity score 
adjusted test of proportions, and the type I error rate will be adjusted for multiple 
testing.  
The primary outcome measure in this study is the proportion of major hip injuries from 
falls reported for intervention group as compared to the control group.  
The secondary outcomes: 
1. 
The proportion of subjects experiencing fall-related hip fractures is lower in 
subjects receiving SOC plus the Tango Belt than in subjects receiving SOC alone. 
2. 
The proportion of subjects experiencing ED visits due to falls is lower in subjects 
receiving SOC plus the Tango Belt than in subjects receiving SOC alone. 
3. 
The proportion of subjects experiencing hospitalizations due to falls is lower in 
subjects receiving SOC plus the Tango Belt than in subjects receiving SOC alone. 
 
10.4 
Measures to Minimize Bias 
Bias in assessments shall be minimized through using established assessment 
procedures under experienced investigators, in addition, all screening data and ongoing 
assessments will be reviewed by an independent observer to ensure integrity. The 
clinical investigator(s) will permit trial-related monitoring, audits, EMR review and 

 
 
 
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regulatory inspection(s), providing direct access to the trial site and to source 
data/documents on request. 
 
11. 
Access and Verification of Source Data 
Unique password-protected logins will be provided to the investigator and/or designee at each 
site to access source data and databases outside of the EMR, including the EDC platform and 
Tango Belt companion app for completion of the CRFs.  Secure access to subjects’ EMR data will 
be provided to site-authorized Sponsor monitor(s) for source data verification and quality 
purposes. 
Source data verification will be performed for 100% of the subjects for enrollment criteria, 
primary endpoint, as well as adverse events. Regulations require that all data in the clinical 
investigation are captured in the patient’s medical records (i.e., source documentation). All 
information generated by patient evaluations/examinations/interviews pertinent to the study 
are to be transferred by the clinical investigator (or designee) into the EDC platform via the CRF. 
Note that the FES-I questionnaire can be completed by the intervention subjects or 
administered by the investigator (or designee) directly using the Tango Belt companion app and 
will not require additional transcription into the EDC platform.  All source documentation must 
be made available for inspection by the monitor, sponsor's staff or other authorized sponsor 
representative. 
Source documents are documents on which information regarding subjects is first recorded. 
They are used to verify the existence of the subject and to substantiate the integrity of the data 
that are collected during a clinical trial. Investigator subject files generally are the basis of source 
document information. This includes but is not limited to original subject files, operative reports, 
progress notes, clinic records, and original recordings. Any additional information relevant to 
the study should be included in source documents. In particular, any deviations from the study 
protocol or procedures should be recorded.  
Information in the subject chart must be accurately reflected on the eCRFs. An Electronic Data 
Capture (EDC) system will be utilized by study site personnel to transfer study data from source 
records/medical records onto common eCRFs. This system is a web-based, secure electronic 
software application (iMedNet). 
 
12. 
Quality Assurance and Quality Control 
This clinical trial sponsored by APT will be conducted under Standard Operating Procedures. The 
CRAs serving as a representative of APT shall follow this study closely by visiting the investigator 
and the study facility regularly and maintaining necessary telephone, electronic and/or letter 

 
 
 
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communication so that any questions and problems that may arise can be promptly resolved. 
Such monitoring will also ensure that the clinical investigation is conducted in accordance with 
this CIP, including all amendments, per FDA Good Clinical Practice Guidelines. Monitoring will 
involve frequent virtual visits by the sponsor's representative to the investigation center to 
verify good management of subjects and the clinical investigation devices, to observe 
procedures and to audit the clinical investigation for quality control purposes (to check device 
supply, presence of required documents, informed consent and for comparison of CRF with 
source data). The monitor maintains current, personal knowledge of the study through 
observation, review of the records, comparison with source documents and discussion of the 
conduct of the study with the investigator. There will also be frequent telephone contact and 
written communication between monitor and clinical investigators. 
During the periodic visits to the investigator, the monitor reviews the source documents used in 
the preparation of the CRFs to verify the accuracy and completeness of the information 
contained in those forms. All data generated during this study, and the source documents from 
which they originated, are subject to inspection by APT, Avania CRO and/ or other regulatory 
authorities. On-site audits may take place independent of and separate from routine monitoring 
or quality control functions. They may take place at various stages during the trial. The clinical 
investigator(s) will timely be informed in writing and/or by telephone that a QC audit is to take 
place and about the items for which the audit will be performed. Whenever possible, the QC 
auditor will be accompanied by the responsible monitor. The auditor may stay at the trial site as 
long as deemed necessary. The conduct of a QC audit will be confirmed by certification. 
 
13. 
Ethics/Protection of Human Subjects 
13.1 
Ethical Standard 
This study will be performed in accordance with the relevant parts of the Code of 
Federal Regulations, ICH Guidelines for Good Clinical Practice (GCP), the Belmont Report 
and any other applicable regional and/or national regulations. 
This protocol has been prepared in accordance with FDA Good Clinical Practices (GCP). 
Both the Sponsor and the clinical investigators have to conduct this clinical investigation 
with strict adherence to the above-mentioned guidelines. 
 
13.2 
Institutional Review Board (IRB) 
Each site will have a designated site investigator and potential  co-investigators within 
the same practice.  For each site, the site investigator must secure Institutional Review 
Board (IRB) approval from each hospital or medical facility where the clinical study will 
be conducted.  

 
 
 
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This approval will cover all physicians designated as co-investigators within that 
practice. A copy of such written approval must be forwarded to APT before medical 
devices can be shipped.   
An independent IRB may be used by those facilities that do not have their own IRB, but 
use of such an IRB is subject to approval by APT.   
The site must submit and, when necessary, obtain approval from the IRB for all 
subsequent protocol amendments and changes to the informed consent document. The 
PI should notify the IRB of deviations from the protocol or SAEs occurring at the site, as 
well as other adverse event reports received from the sponsor or its representatives, in 
accordance with local procedures. This documentation will be kept on file at the sponsor 
and each site.  
The site will be responsible for obtaining annual IRB approval or renewal throughout the 
duration of the study, notifying the IRB of study completion, and providing the final 
study report, as required by the IRB. This documentation will be kept on file at the 
sponsor and each site. 
APT must approve the drafted site-specific Informed Consent Form, which will be used 
for consenting subjects, prior to submitting the document to the IRB. If the IRB requires 
additional changes, these must be reviewed and approved by APT prior to resubmission 
to the IRB. A copy of the final, IRB-approved Informed Consent Form and all other IRB 
approved study documents must be submitted to APT. 
 
13.3 
ICF Process 
The ICF process is generally described in Section 5.3; further details are provided below. 
Consent Procedures and Documentation: 
Before any non-standard of care study-related activity may occur, including  recruitment 
and enrollment into the study, subject must provide written consent to participate in 
the study after the nature, scope and possible consequences of the clinical study have 
been explained in a form understandable to them.  Each prospective candidate will be 
given a full explanation of the study. If the subject has an identified POA, that individual 
will be contacted with the consent information for proxy signature.  After this essential 
information has been provided to the subject and the site investigator is assured that an 
individual candidate understands the implications of participating in this study, the 
subject will be asked to sign an informed consent form. Written informed consent must 
be obtained prior to enrollment in the study. The Informed Consent Form includes all 
the relevant elements currently required by GCP. 

 
 
 
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A notation that written informed consent has been obtained will be made on the 
subject's CRF. The original of the signed Informed Consent Form will be kept by the site 
investigator and a copy will be provided by the site investigator to the subject. If there is 
a POA for the subject, a copy of the POA documentation from source documentation 
will be obtained by the site investigator and notation of POA signature on behalf of the 
subject noted on the CRF. 
Consent on behalf of a subject by a POA may be obtained with eSignature and/or verbal 
agreement with signature obtained via paper copies mailed or eSignature. Copies of 
signed ICF will be held by the site investigator and a copy shared with the POA. 
The informed consent process should include at minimum the following: 
• 
Provide potential subjects with a complete copy of the correct version of the IRB 
informed consent document.  
o Revisions to the protocol based on new information or changes in study 
procedure may require new versions of the consent therefore it is 
important to ensure a complete copy of the correct consent be given to the 
subject for review.  
o Different sites may require different IRB approval and consent documents; 
therefore, it is important to use the proper consent version per subject if 
your site has multiple satellite sites and IRB reviews.  
• 
Allow potential subjects plenty of time to review the informed consent document.  
• 
Provide subjects ample opportunity to ask questions to the site investigator or 
appropriately trained and delegated study staff member to ensure the subject 
understands the study requirements, potential risks, and their rights as a research 
subject. 
• 
If the subject agrees to participate, have the subject and study staff obtaining the 
consent, sign and date the Informed Consent Form.  
o Please be sure to review signatures so that the date added to the signature 
is the day the subject and person obtaining consent signed the ICF.  
o IRBs may require the subject to initial and date each page to show that 
he/she read the consent. It is best practice for the person obtaining the 
consent to review the document to ensure all pages are appropriately 
initialed as applicable. 
• 
The original signed consent should be filed at the site and be made available for 
review to monitors. Document entire informed consent process in the subject’s 
medical chart. 
 
 
13.4 
Participant and Data Confidentiality 
Information about subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 

 
 
 
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(HIPAA). Every reasonable effort will be made to protect the confidentiality of the 
subjects throughout the study. Participant confidentiality is strictly held in trust by the 
participating investigators, their staff, and the sponsor(s) and their agents. Therefore, 
the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor, other authorized representatives of the sponsor, representatives of 
the IRB or regulatory bodies may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, 
clinic, or hospital) for the participants in this study. The clinical study site will permit 
access to such records. The study participant’s contact information will be securely 
stored at each clinical site for internal use during the study. In the event that a subject 
withdraws authorization to collect or use Personal Health Information, the investigator 
retains the ability to use all information collected prior to the withdrawal of 
authorization. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by local IRB and Institutional regulations. The 
study data entry and study management systems used by clinical sites will be secured 
and password protected. At the end of the study, all study databases will be de-
identified and archived at the sponsor. 
 
The information contained herein is provided to you in confidence and should not be 
disclosed to others, without written authorization from APT, except to the extent 
necessary to obtain informed consent from those persons to whom the device will be 
administered. Identities of individuals participating in clinical research will be kept as 
confidential as is possible within the law. While the information obtained in clinical 
studies may be published in scientific journals or presented at scientific meetings, the 
identity of participants will not be revealed. Representatives of the sponsor may inspect 
study records to assess the results of this research. Avania CRO, a Contract Research 
Organization and monitor of the study will conduct source document verification to 
assure the accuracy of information collected.  
Representatives of other applicable state and/or federal regulatory agencies may also 
inspect subject records. Due to the need to release information to these parties’ 
absolute confidentiality of subject records is not guaranteed. 
 
14. 
Data Handling and Record Retention 
14.1 
Data collection and Management Responsibilities 

 
 
 
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Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the site investigator. The investigator is required to maintain detailed 
source documents on all subjects who are screened and/or enrolled in the study. 
Source documents include subject records, investigator subject trial files, as well as the 
results of tests and assessments. The date the subject began and exited the trial and a 
notation as to whether the subject completed the trial or was discontinued, including 
the reason for discontinuation should be included in the subject file. 
All source documents should be completed in a neat, legible manner to ensure 
accurate interpretation of data. Dark ink is required to ensure clarity of reproduced 
copies. When making changes or corrections, cross out the original entry with a single 
line, and initial and date the change. DO NOT ERASE, OVERWRITE, OR USE CORRECTION 
FLUID OR TAPE ON THE ORIGINAL.  
The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. Case Report Forms (CRFs) are used for the collection 
and recording of data at the Investigative Center. The investigator is responsible for 
the timely completion and updating of the CRF. Data reported in the CRF derived 
from source documents should be consistent with the source documents or the 
discrepancies should be explained and captured in a progress note and maintained in 
the participant’s official study record.  
Serious Adverse Events (SAEs) are to be reported within 24 hours of knowledge of the 
event. 
Incoming data are reviewed to identify inconsistent or missing data and adverse 
events. Data issues will be addressed with the site and/or during site visits. All hard 
copy forms and data files will be secured to ensure confidentiality. Copies of the 
retrieved CRFs will be kept within the Trial Master File at the sponsor or the sponsor’s 
designee. 
Avania CRO will ensure the Final Study Report is completed within 3 calendar months 
following the locking of the clinical database and ensure that all necessary documents 
are available. Avania CRO will ensure that the Final Study Report is an accurate 
presentation of the study and will liaise with APT during its compilation and production.  
Avania CRO will send a regular and prompt monthly report to APT containing details of  
study status. Copies of all monitoring reports are also to be sent to APT. CRF’s will be 
used to record demographic, procedural and follow-up data. Adverse events, which may 
occur during this study, will be recorded on the Adverse Events form. The adverse 
events and incidence of morbidity and mortality will be reviewed with the clinical 
investigators to assess the safety of the investigational device and the surgical 
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Statistical results such as confidence intervals and descriptive statistics for intervention 
safety and primary effectiveness outcomes will be presented by site and in aggregate. 
Likewise, incidence of adverse events will be presented by site and in aggregate.  
Lastly, belt-collected data from intervention subjects will be securely maintained in 
APT’s cloud for potential future development of new product features and 
enhancements by APT personnel or development partners. 
 
14.2 
Study Record Retention 
Records will be held in the electronic trial master file with Avania CRO for the period of 
time consistent with GCP. No records will be destroyed without the written consent of 
the sponsor.  It is the responsibility of the Sponsor to inform the investigator when 
these documents no longer need to be retained. 
Records to be retained include: all study-related correspondence, documentation of 
device receipt and disposition, each subject’s case history and record of exposure to the 
device, the protocol and amendments, IRB information pertaining to reviews and 
approvals, Investigator Agreements, and dates and reasons for any protocol deviations. 
 
14.3 
Protocol Deviations 
A minor protocol deviation occurs when, with non-significant consequences, the 
activities on a study diverge from the Institutional Review Board-approved protocol or 
GCP requirements. The noncompliance may be either on the part of the participant, the 
investigator, or the study site staff.  
A major protocol deviation is a divergence from the protocol that materially (a) reduces 
the quality or completeness of the data, (b) makes the Informed Consent Form 
inaccurate, or (c) impacts a subject's safety, rights, or welfare. Examples of major 
deviations may include the following: 
• 
Inadequate or delinquent informed consent 
• 
Inclusion/exclusion criteria not met 
• 
Unreported serious adverse events or fall event 
• 
Materially inadequate record keeping 
• 
Intentional deviation from protocol, Good Clinical Practice, or regulations by 
study personnel 

 
 
 
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It is the responsibility of the site to use continuous vigilance to identify deviations and 
violations. Monitor also continually monitors for discrepancies, providing instructions 
where needed.   
Site reports within 3 working days of identification of the protocol deviation, or within 5 
working days of the scheduled protocol-required activity. All deviations must be 
addressed in study source documents and reported to the sponsor or designee. 
Corrective action at the site is initiated where a systemic or repeated deviation-type 
occurs.   
Site reports major protocol deviations immediately, and corrective action is initiated. 
Protocol deviations must be sent to the IRB per their required reporting guidelines.  The 
site PI/study staff is responsible for knowing and adhering to their IRB requirements.  
14.4 
Publication and Data Sharing Policy 
Prior to submitting for publication, presenting, using for instructional purposes, or 
otherwise disclosing the results of the study, the investigator agrees to allow APT a 
period of at least 60 days (or, for abstracts, at least 5 working days) to review the 
proposed publication or disclosure prior to its submission for publication or other 
disclosure. Publications or disclosures of study results shall not include other 
confidential information belonging to APT. If the proposed publication/disclosure risks 
APT’s ability to patent any invention related to the study, the publication or disclosure 
will be modified or delayed, at the investigator's option, a sufficient time to allow APT to 
seek patent protection of the invention. For multicenter studies, the first publication or 
disclosure shall be a complete, joint multicenter publication or disclosure. This 
statement does not give APT any editorial rights over the content of a publication or 
disclosure, other than to restrict the disclosure of APT’s confidential information. If a 
written contract for the conduct of the study which includes publication provisions 
inconsistent with this statement is executed, then that contract's publication provisions 
shall apply rather than this statement. 
 
15. 
Investigator Reports 
Study investigator(s) will provide monthly reports (verbal or written) to APT on the status of the 
study, including any concerns related to complying with study procedures, and any other matter 
which could potentially affect the successful execution and/or integrity of the study. Investigator 
reports will also include all related or non-related device malfunctions/deficiencies, any 
withdrawal of IRB approval and final IRB report (upon termination or completion of the study). 
 
 

 
 
 
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16. 
Termination of Study and Study Site Participation 
The sponsor may terminate the study at any time. The sponsor reserves the right to terminate 
the study site participation and remove appropriate study materials at any time.  Specific 
instances that may preciinvestigatortate such terminations include but are not limited to the 
following: 
- 
Failure of the Investigator to enroll patients into the study at an 
acceptable rate  
- 
Failure of the Investigator to comply with pertinent regulations of 
appropriate regulatory authorities  
- 
Insufficient adherence to protocol requirements  
- 
Insufficient adherence to GCP 
- 
Submission of knowingly false information from the research facility to 
the sponsor, study monitor, or appropriate regulatory authority 
- 
Demonstration of misconduct 
The site Investigator may also discontinue study participation with suitable written notice to 
APT.  
Refer to Section 5.5. 
 
17. 
Regulatory Considerations 
This study will be executed with the controls appropriate for non-significant risk studies as 
defined in FDA GCP guidelines. 
 
18. 
Appendices 
 
 
 
 
 
 
 

 
 
 
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18.1 
 Informed Consent Form 
 
RESEARCH SUBJECT INFORMED CONSENT FORM 
 
PROTOCOL TITLE:  
Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult  
 
 
 
Population with a Wearable Smart belt 
 
PROTOCOL ID:  
Tango® Study 
 
SPONSOR:     
 
Active Protective Technologies, Inc 
 
Facility: 
 
 
 
 
 
PRINCIPAL  
INVESTIGATOR: 
 
 
INVESTIGATOR 
CENTER &  
SATELLITE SITES: 
 
 
 
 
CO-INVESTIGTOR(S):     
 
 
CO-ADVISOR:   
 
 
 
 
STUDY COORDINATOR:    
 
 
 
STUDY-RELATED  
EMERGENCY  
PHONE NUMBER:  
 

 
 
 
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Introduction 
 
You are being asked to take part in this research study to see if using the Tango Belt, a wearable 
smart belt, is effective in mitigating major hip injuries due to a fall. This clinical investigation will 
study the use of the Tango Belt in up to 20 senior care settings as an adjunctive intervention to 
standard-of-care (SOC) to mitigate injuries related to falls in an injury older adult population at-
risk for fall injury. 
 
 This document is an Informed Consent Form and has important information about the reason 
for the study, what you will do if you choose to be in the study, and the way we would like to 
use information about you and your health. This form will give you detailed information about 
the study, so please ask your Study Doctor or someone from the Study Center Staff to explain 
any words or information that you do not clearly understand.   
 
The Tango Belt, worn around the waist, can detect a serious hip-impacting fall-in-progress using 
built-in sensors and deploy an airbag to protect the hips from impact forces. When connected to 
Wi-Fi, the Tango Belt can send automated fall and impact alerts to caregivers. The airbags in the 
Tango Belt will only deploy when sensors indicate the fall motion is one in which a serious hip 
injury may occur. The Tango Belt will be sized and fit to you for comfortable wearing around the 
waist at all times with removal for charging at least 2 times a week and removal for showering. 
The Tango Belt is intended to be worn for at least 6 months during the trial.  
 
Before you decide if you want to take part in this study, it is important for you to understand:  
• 
why the research is being done,  
• 
how your information will be used,  
• 
what the study will involve, and  
• 
the possible benefits, risks and discomforts for you when you take part. 
 
Please take your time to make your decision about taking part in this research study.  You may 
discuss your decision with your friends and family.  You can also discuss it with your health care 
team.  If you have any questions, you can ask your study doctor for more explanation. 
After you are sure that you clearly understand the risks and benefits of taking part in this study 
and if you choose to take part in the study, you will be asked to sign the Informed Consent 
Form.  You should not sign the Informed Consent Form if you have any questions that have not 
been answered.  By signing the Informed Consent Form, you are confirming that the study has 
been explained to you, and that you give your permission to be a part of the study.  You will be 
given a copy of this Patient Information Sheet and the signed and dated Informed Consent 
Form.   
 
 
 

 
 
 
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Why you are being invited to take part in a research study?  
You are being invited to participate in this clinical study because you are at risk of falls and 
major injuries from falls. Participating in this study may reduce/avoid a major hip injury due to a 
fall and need for urgent medical treatment. 
 
Who can you talk to about this research study? 
If you have questions, concerns, or complaints, or think the research has hurt you, you can talk 
to the study team, which includes a physician and a researcher, or you may call Active Protective 
Technologies, Inc at 215-399-9763.  
 
This research has been reviewed and approved by ______________Institutional Review Board 
(IRB). An IRB reviews research projects so that steps are taken to protect the rights and welfare 
of human subjects taking part in research.  You may talk to them at (   )___-______ for any of 
the following: 
 
• 
Your questions, concerns, or complaints are not being answered by the research team. 
• 
You cannot reach the research team. 
• 
You want to talk to someone besides the research team. 
• 
You have questions about your rights as a research subject. 
• 
You want to get information or provide input about this research. 
 
Why is this study being done? Why are we doing this research? 
Every year in the United States there are approximately 3 million fall-related emergency room 
visits for geriatric adults.  Of the 3 million emergency room visits, approximately 300,000 of 
those lead to hospital admissions due to hip fractures .  This coincides with the Centers for 
Disease Control (CDC) analysis that 1 out of 4 adults over the age of 65 (i.e., geriatric) will fall 
each year and those falls may occur more than once in a year .  As a result of these high 
numbers, falls are the leading cause of injury-related deaths among the geriatric population and 
cost over $50 billion in total medical costs. Despite efforts made throughout healthcare settings 
in integration of standard of care for fall injury risk, the number of older adults experiencing falls 
and fall related injuries has increased or remained unchanged since 2012.  Furthermore, fall 
death rates in the U.S. increased 30% from 2007 to 2026 for older adults.  As such, there is a 
growing need for alternative care methods for geriatric individuals who are at high risk of fall as 
the existing standard of care is not effective at reducing the overall rate of fall injuries.  As a 
solution to this problem, APT Technologies has developed the Tango Belt, a wearable belt 
designed to fill the need for protecting the hips during a serious, hip-impacting fall. 
 
The Tango Belt device has amassed over 80,000 hours of wear time on real older adult users in 
the past several years and is currently being used in senior care living and independent living 
residences throughout the US. The belt has been shown to be safe in all real-world use to date, 
and no serious or life-threatening events related to the device have been reported.  

 
 
 
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How long will I be in the study? How long will the research last?  
You will be in the study for a minimum of 6 months. This study consists of the following 4 Visits: 
• Baseline/Screening Visit (Day 1): 
• 
Introduction to the device, measurement for the correct size and provision of the 
Tango Belt with sizing adjustments provided by care team.  
• 
A 7-question survey on balance confidence may be taken if appropriate 
• 
Any needed data will be taken from your electronic health record (EHR) 
• Follow up Visit (14 days (+/- 2 days) 
• 
Data on wear compliance obtained from Tango Belt Companion App 
• 
If compliance is 64% or >, subject will continue with study enrollment 
• 
If compliance is < 64%, subject is excused from study enrollment 
• Follow Up Visits (90 days (+/- 10 days) and Unscheduled 
• 
Data obtained from the EHR 
• 
7-question balance confidence survey repeated if appropriate 
• Completion Visit (180 days (+/-30 days): 
• 
Discharge use of the device 
• 
Data obtained from the EHR 
• 
7-question balance confidence survey repeated if appropriate 
 
How many people will take part in the study?  
Between 200 to 400 people will be included in treatment part of the study. 
 
What will happen if I take part in this research study? What happens if I say yes, I want to be 
in this research?  
Study Procedures:  
This is what will happen if you take place in the study: 
 
Visit 1 - Baseline/Screening Visit (+/-14 days) – location of residence 
• A Medical and fall history (since age 50) will be collected via medical record review, 
this review will include: 
o Fall and fall injury history  
o Current fall risk factors and mitigation care plan as determined by the 
Stopping Elderly Accidents, Deaths & Injury (STEADI) algorithm 
o Current mental status as noted by most recent Brief Interview for 
Mental Status (BIMS) score 
o Current mobility level 
• A waist measurement will be done with adjusting of size for comfort; 
• A Tango Belt will be prescribed to be worn up to 24 hours/day with removal for 
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• You will be asked to complete a questionnaire if appropriate; Falls Efficacy Scale – 
International (short version) FES-I. 
 
Visit 2 Run-in period (14 days +/- 2): 
• 
Adherence to wearing of the device up to 24 hours/day with removal for charging and 
showers will be assessed for compliance to use of the device for decision of 
continuation in the study. Adherence to the compliance to wear of the Tango Belt is 
defined as at minimum 64% (at least 1 hour a day for 9 days out of 14). If the subject is 
not utilizing the device for at least the minimum amount of time, they withdrawn from 
the study at this time and the Tango Belt will be returned.  If they demonstrate 
adherence to compliance, they will continue with enrollment in the study.  
 
Visit 3 - Follow Up Visits (90-day +/- 10 day) and Unscheduled Visits – location of residence: 
Midway through the study run time, approximately 3 months: 
• Adherence to wearing of the device up to 24 hours/day with removal for charging and 
showers. 
• Your medical record will be reviewed for obtaining the updated status on the 
following: 
o Any adverse events or unexpected medical problems you may have 
experienced since baseline  
o Any fall events that you may have experienced since baseline 
o Current level of mobility 
o Any changes to your fall mitigation plan of care since baseline 
• 
Review of medical record for any changes of status; 
• 
You will be asked to  complete a current FES-I short version (if appropriate) 
• 
Your smart belt will be assessed for any device deficiencies. 
 
End of Study (180 Days +/- 30 days) – location of residence 
At the end of the study run time, approximately 6 months: 
• 
Adherence to wearing the device of the device up to 24 hours/day with removal for 
charging and showers. 
• 
Your medical record will be reviewed for obtaining the updated status on the following: 
o Any adverse events or unexpected medical problems you may have experienced 
since baseline  
o Any fall events that you may have experienced since baseline 
o Current level of mobility 
o Any changes to your fall mitigation plan of care since baseline 
• 
Review of medical record for any changes of status; 
• 
You will be asked to complete a current FES-I short version (if appropriate)  
• 
Your smart belt will be assessed for any device deficiencies.  The Tango Belt will be 
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What are my responsibilities if I take part in this research? What are my rights if I take part in 
this study? 
Your participation in the study is voluntary. You may choose either to take part or not to take part in the 
study.  If you decide to take part in this study, you may leave the study at any time.   No matter what 
decision you make, there will be no penalty to you and you will not lose any of your regular benefits.  
Leaving the study will not affect your medical care.  You can still get your medical care from our 
institution.  
 
What happens if I do not want to be in this research? What other choices do I have if I do not 
take part in this study?  
Our study team will refer you back to your Primary Care Physician to discuss alternative treatment 
options.  
Can I stop being in the study? What happens if I say yes, but I change my mind later?  
You can decide to stop at any time.  You can tell a study team member if you are thinking about 
stopping or decide to stop.    If you choose to discontinue the study at any time, the Study Evaluator will 
contact you.   
What side effects or risks can I expect from being in the study? Is there any way being in this 
study could be bad for me? 
Based on studies previously performed, the risks that could potentially occur from participation in this 
investigation are: 
• 
Discomfort and moderate, reversible bruising and/or skin irritation underneath the belt; 
• 
Soreness due to sustained wear caused by the weight of the belt; 
• 
Pinching of fingers or belly skin which may be caught in-between buckle halves when putting on 
the belt; 
• 
Falls and fall-related injuries may still occur, including injuries such as abrasion, contusion, 
concussion, whiplash, and/or fracture. 
 
What are the reproductive risks?   
This study is intended for individuals 65 years and older and thus has no reproductive risks. 
Are there benefits to taking part in the study? Will being in this study help me in any way? 
The benefits associated with the use of Tango Belt are the possible avoidance of incurring a major hip 
injury in the event of a serious hip-impacting fall while wearing the Tango Belt. The knowledge of the 
offered protection and alerting capabilities of the Tango Belt when worn may also improve the wearer’s 
confidence and encourage mobility in the senior residence setting.  

 
 
 
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What are the costs of taking part in this study? Do I have to pay for anything while I am on 
this study? 
There is no cost to you for being in the study or for receiving treatment. The use of the Tango 
Belt will be complimentary while being a participant in the study.  
How is this study funded? Is anyone receiving compensation? 
This study is funded by ActiveProtective Technologies, Inc. The sponsor will be providing all 
materials to the sites including the Tango Belts. Any time that the clinical team members 
including Principal Investigator, Site Investigators, and any Research Assistants of the clinical 
site or otherwise spend performing study activities will be reimbursed to them by Active 
Protective Technologies, Inc. 
What happens to the information we collect? Will my medical information be kept private? 
Protected Health Information is any health information or information in your medical record that can 
be used to identify you such as your name, address, telephone number, or identification numbers, or 
any other direct personal identifier.   
During the study, the Study Doctor and Study Center staff will collect and record information about you 
and your health status.  This may include your birthdate, sex, race, ethnic origins, medial history, and 
data obtained from study related visit assessments. The Tango Belt will also automatically collect data 
on usage, alerts, and motions while worn.  This information along with results from study participation 
and follow-up is considered your “Study Data”.   
Your Study Data will not be identified on any study document by name, address, telephone number, or 
identification numbers, or any other direct personal identifier.   Instead, you will be identified by an 
assigned code which will replace your Protected Health Information so that your Study Data cannot be 
easily linked to directly to you.  The Study Doctor will keep the list that matches the assigned code to 
your name. That list will not be provided to the Sponsor, and only the Study Doctor and study center 
staff will have access to the list. 
Your coded Study Data may be kept and shared by the Sponsor indefinitely or as long as required for 
business purposes related to the research study, applicable law, regulation, statute, or Sponsor’s policy.   
The Study Doctor also may share your coded Study Data with all applicable regulatory agencies in this 
country and in other countries where research studies involving Tango ® Belt are taking place. 
Information shared with these entities has the potential to be shared further and then may no longer be 
protected.   
We will do our best to make sure that the personal information in your medical record will be kept 
private.  Your data will be kept on a secure, HIPAA compliant server.  However, we cannot guarantee 
total privacy.  Your personal information may be given out if required by law.  If information from this 

 
 
 
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study is published or presented at scientific meetings, or for the Sponsor to obtain FDA approval, your 
name and other personal information will not be used.  
By signing this consent form, you grant permission for personal data and medical information 
about you obtained during this study (your Study Data) to be made available to authorized or 
approved representatives of the regulatory authorities and other government agencies. You also 
grant permission for your personal data to be made available to the Sponsor auditors, the study 
monitor, other study personnel, and ethics committees. 
  
Organizations that may look at and/or copy your medical records for research, quality 
assurance, and data analysis include: 
• 
Holy Redeemer Health System Institutional Review Board (IRB), a group of people who review the 
research study to protect your rights; 
• 
Government agencies, including the Food and Drug Administration (FDA) and the Office for Human 
Research Protections (OHRP).  These agencies may review the research to see that it is being done 
safely and correctly. 
 
You have the right to withdraw your permission to use your Study Data at any time. In that case, you 
may be asked to communicate this in writing to your Study Doctor. In this case, you will be removed 
from the study. 
 
You may decide not to give permission for collection of your Study Data in this study. In that case, you 
will not be able to participate. This is because the Study Doctor and study center staff would not be able 
to collect the information needed to evaluate the smart belt device. 
 
If you withdraw your permission after you have started in the study, the Study Doctor and study center 
staff will stop collecting your Study Data.  Although new information will no longer be collected, the 
information already collected will be kept and used as explained in this Informed Consent Form.  
Additional information will be gathered if you have a side effect related to the study.  
Can I be removed from the research without my OK? 
Yes, the study or your participation in the study may be stopped without your consent. Some reasons 
the Sponsor may stop the study or put the study on hold include: 
• 
The smart belt has been shown unlikely to work 
• 
Decisions made in the business or commercial interests of the Sponsor 
• 
Decisions made by the regulatory authorities or ethics committees 
 
Reasons the Study Doctor can stop your participation include: 

 
 
 
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• 
If you do not qualify for inclusion in the Treatment Period of the study, you are discontinued at 
that point.  
• 
 If you are unable to maintain the treatment schedule and utilize the device for the minimum of 
6 months, or 
• 
If you developed a medical condition that requires an intervention interfering with the use of 
the Tango Belt.  
 
What else do I need to know? Where can I get more information?  
The Sponsor and responsible party for reporting results of the study is ActiveProtective Technologies, 
Inc.  Results from this research study will be available after the study research study is completed.  
Should you wish to see the results, please ask your Study Doctor. You will not be identified in any report 
or publication. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law.   This Web site will not include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this website at any time.1 
We will tell you about new information or changes in the study that may affect your health or your 
willingness to continue in the study.  
You have the right to look at your medical records during this research study. To request review of your 
medical records, Contact the Study Coordinator.   
 
 
 
 

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Informed Consent 
Signatures 
I have been given a copy of all 58 pages of this form.  I have read the consent form, or it has been read 
to me.  This information was explained to me and my questions were answered. 
I have read (or someone has read to me) the information in the Informed consent in a language that I 
understand well, and the research study has been explained to me.  I have been given ample time to ask 
questions and have been told whom to contact if I have more questions.  All of my questions about the 
study and my participation in it have been answered to my satisfaction. 
I voluntarily agree to be in the research study described in the Informed Consent Form and I understand 
that a copy of the complete Informed Consent Form will be provided to me after I sign it. 
I authorize the use and disclosure of my Study Data as described in the Informed Consent Form. 
I am free to stop taking part in this study at any time for any reason and my choice to stop taking part will 
not affect my future medical care.  I agree to follow the Study Doctor's instructions and will tell the doctor 
as soon as possible if I have any changes in my health.  By signing this document, I am not giving up any 
of my legal rights. 
Name of Patient (please print) ___________________________________________________
Patient Signature_________________________________ Date_____________ Time__________

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Is a Legally Authorized Representative (LAR) signing this consent? 
 Yes   No  
Name of Patient (please print) ___________________________________________________ 
Name of Legally Authorized Representative (please print)____________________________ 
Legally Authorized Representative Signature ______________________________________ 
Date__________    Time__________ 
Was verbal consent offered by LAR pending above signature?  Yes    No      If Yes, 
Telephone number where LAR was reached: ______________________________________ 
I hereby declare that I have informed the above patient verbally and in writing about the nature, 
significance, implications, and risks of the study named above. The patient has been asked if any 
questions have arisen regarding these procedures, and these questions have been answered.  A 
signed and dated second original of this Patient Information Sheet and Informed Consent Form have 
been provided to the patient.  
Name of Person Obtaining Consent (please print) ____________________________ 
Person Obtaining Consent  
Signature____________________________________________Date______________ Time________ 
Is the Impartial Witness Statement applicable? 
Yes 
No 
If this document is read to the patient because the patient is unable to read the form, an impartial 
witness not affiliated with the research or Study Doctor must be present for the consent and sign the 
following statement.  An impartial witness is a person, who is independent of the study, who cannot be 
unfairly influenced by people involved with the study, who attends the informed consent process if the 

 
 
 
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patient cannot read, and who reads the informed consent and any other written information provided 
to the patient. 
 
I confirm that the information in this document and any other written information was accurately 
explained to, and apparently understood by, the patient. The patient freely consented to be in the 
research study. 
 
Name of Witness and Relationship (please print) _____________________________ 
 
 
Witness signature_____________________________________ Date___________     Time______ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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18.2  Study Questionnaires 
 
 
 
 
 
 
 
 
 
 

 
 
 
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18.3  Literary references 
 
i CDC Facts About Falls. (2021, August 6). Centers for Disease Control and Prevention. 
https://www.cdc.gov/falls/facts.html. 
ii Bergen G, Stevens MR, Burns ER. Falls and Fall Injuries Among Adults Aged ≥65 Years - United 
States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Sep 23;65(37):993-998. doi: 
10.15585/mmwr.mm6537a2. PMID: 27656914. 
iii Florence CS, Bergen G, Atherly A, Burns E, Stevens J, Drake C. Medical Costs of Fatal and 
Nonfatal Falls in Older Adults. J Am Geriatr Soc. 2018 Apr;66(4):693-698. doi: 10.1111/jgs.15304. 
Epub 2018 Mar 7. PMID: 29512120; PMCID: PMC6089380. 
iv Panel on Prevention of Falls in Older Persons, American Geriatrics Society and British Geriatrics 
Society. Summary of the Updated American Geriatrics Society/British Geriatrics Society clinical 
practice guideline for prevention of falls in older persons. J Am Geriatr Soc. 2011 Jan;59(1):148-
57. doi: 10.1111/j.1532-5415.2010.03234.x. PMID: 21226685. 
v CDC STEADI – Older Adult Fall Prevention, Resource Algorithm for Fall Risk Screening, 
Assessment, and Intervention. 2019. Centers for Disease Control and Prevention. 
www.cdc.gov/steadi. 
vi  Stefanacci S, Haimowitz D. Stand By Me – Preventing Falls. Geriatric Nursing, Vol 33, No 2. 134-
136(2012) doi:10.1016/j.gerinurse.2012.02.003 
vii Kannus P, Parkkari J, Niemi S, Pasanen M, Palvanen M, Järvinen M, Vuori I. Prevention of hip 
fracture in elderly people with use of a hip protector. N Engl J Med. 2000 Nov 23;343(21):1506-
13. doi: 10.1056/NEJM200011233432101. PMID: 11087879. 
viii Parker MJ, Gillespie WJ, Gillespie LD. Effectiveness of hip preotectors for preventing hip 
fractures in elderly people: systematic review. BMJ. 2006;332(7541):571-574. DOI: 
10.1136/bmj.3875324.7C 
ix Bulat T, Powell-Cope G, Rubenstein L. Perceived Barriers and Facilitators for the Use of External 
Hip Protectors. Gerontological Journal. June 2004, Vol 3, No1.  
x  Parkkari J, Heikkila J, Kannus P. Acceptability and Compliance with Wearing Energy-Shunting Hip 
Protectors: a 6-Month Prospective Follow-Up in a Finnish Nursing Home. Age and Aging 
1998;27:225-229 
xi Moreland B, Kakara R, Henry A. Trends in Nonfatal Falls and Fall-Related Injuries Among Adults 
Aged > 65 Years – United States, 2012-2018.MMWR Morb Mortal Wkly Rep. 2020 Jul 
10;69(27)875-881. Doi: 10.15585/mmwr.mm6927a5 
xii Bhasin S, Gill T, Reuben D, Latham N, Ganz D, Greene E, et al. A Randomized Trial of 
Multifactorial Strategy to Prevent Serious Fall Injuries. N Engl J Med 2020;393;129-40. 
DOI:10.1056/NEJMoa2002183 
xiii Gill T, Bhasin S, Reuben D, Latham N, Araujo K, Ganz D, et al. Effect of Multifactorial Fall Injury 
Prevention Intervention on Patient Well-Being: The STRIDE Study. JAGS. 69;173-179.2021. 
xiv Yang Y, Komisar V, Shishov N, Lo B, Korall A, Feldman F, Robinovitch S. The Effect of Fall 
Biomechanics on Risk for Hip Fracture in Older Adults: A Cohort Study of Video-Captured Falls 
in Long-Term Care. Journal of Bone and Mineral Research. Vol 35, No. 10.2020 Pp 1914-1922. 
DOI: 10.1002/jbmr.4048 
 

 
 
 
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xv Quigley P, Singhatat W, Tarbert R. Technology Innovation to Protect Hips from Fall-Related 
Fracture. 2019, Phys Med Rehabil Res. Vol 4. 104. DOI: 10.15761/PMRR.1000205 
xvi Tarbert R, Singhatat W. Skilled Nursing Resident Adherence with Wearable Technology to Offer 
Safer Mobility and Decreased Fall Injuries. 2020. Journal of Pat Safety and Risk Man. DOI: 
10.1177/2516043520979193 
 

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Statistical Analysis Plan 
For 
 
[COP-0001] Smart Belt Fall Injury Mitigation Study 
Active Protective Technologies, Inc 
 
 
Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult 
Population with a Wearable Smart Belt 
 
 
COP-0001 
Version 2.0, dated 07 DEC 2023 
 
 
 

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SIGNATURE PAGE  
The undersigned hereby jointly declare that they have reviewed the Statistical Analysis Plan and agree 
to its form and content. 
Author 
Name 
Function 
Signature 
Date 
Patrick O’Connor 
Biostatistician 
 
 
 
 
Approval by 
Name 
Function 
Signature 
Date 
 
Rebecca Tarbert 
Director, Clinical 
Operations 
 
 
Irma Alvarez  
Project Manager 
 
 
 
 
 
 
07-Dec-2023 | 11:58:32 AM EST
07-Dec-2023 | 11:55:18 AM EST
07-Dec-2023 | 9:11:15 AM PST

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TABLE OF CONTENTS 
Document History ......................................................................................................................................... 5 
1 
Abbreviations ........................................................................................................................................ 6 
2 
Summary ............................................................................................................................................... 7 
3 
Study Objectives and Endpoints ........................................................................................................... 9 
3.1 
Study Objective ............................................................................................................................. 9 
3.1.1 
Primary Objective .................................................................................................................. 9 
3.1.2 
Secondary Objective ............................................................................................................. 9 
3.2 
Study Endpoints ............................................................................................................................ 9 
3.2.1 
Primary Endpoint .................................................................................................................. 9 
3.2.2 
Secondary Endpoints ............................................................................................................ 9 
3.2.3 
Ancillary Endpoints ............................................................................................................. 10 
4 
Sample Size ......................................................................................................................................... 10 
4.1 
Interim Analyses.......................................................................................................................... 11 
4.1.1 
Sample Size Re-Estimation .................................................................................................. 11 
4.2 
Final Analyses and Reporting ...................................................................................................... 12 
5 
Analysis Populations ........................................................................................................................... 12 
5.1 
Historical Control Population ...................................................................................................... 12 
5.2 
Intervention Population .............................................................................................................. 12 
5.2.1 
Intent to Treat Population (ITT) .......................................................................................... 12 
5.2.2 
Per-Protocol Population (PP) .............................................................................................. 13 
5.2.3 
Adherence Population ........................................................................................................ 13 
5.2.4 
Safety Population ................................................................................................................ 13 
6 
General Issues for Statistical Analysis ................................................................................................. 13 
6.1 
Analysis Software ........................................................................................................................ 13 
6.2 
Disposition of Subjects and Withdrawals ................................................................................... 13 
6.2.1 
Intervention Population ...................................................................................................... 13 
6.2.2 
Historical Control Population .............................................................................................. 14 
6.3 
Methods for Withdrawals and Missing Data .............................................................................. 14 

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6.3.1 
Multiple Imputation ............................................................................................................ 14 
6.4 
Protocol Deviations ..................................................................................................................... 14 
6.5 
Multiple Comparisons and Multiplicity ....................................................................................... 15 
6.6 
Demographics ............................................................................................................................. 15 
7 
Effectiveness Analyses ........................................................................................................................ 15 
7.1 
Propensity Score Method ........................................................................................................... 16 
7.2 
Primary Effectiveness Analysis .................................................................................................... 17 
7.3 
Secondary Effectiveness Analysis ............................................................................................... 17 
8 
Adverse Events .................................................................................................................................... 18 
8.1 
All Adverse Events ....................................................................................................................... 18 
8.2 
Serious Adverse Events ............................................................................................................... 19 
8.3 
Device Related Adverse Events ................................................................................................... 19 
8.4 
Deaths ......................................................................................................................................... 19 
9 
Summary of Changes from the Protocol ............................................................................................. 20 
10 Reporting Conventions ....................................................................................................................... 20 
11 References .......................................................................................................................................... 20 
 
 
 

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DOCUMENT HISTORY 
 
Revision Date 
Author 
Version 
Reason for Change 
NA 
Patrick O’Connor 
1.0 
NA – Initial Version 
07DEC2023 
Patrick O’Connor 
2.0 
Removed 90-day as a timepoint for the primary and 
secondary endpoints 
 
 
 
 
 
 
 

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1 ABBREVIATIONS 
Abbreviation 
Definition 
AE 
Adverse Event 
CRF 
Case Report Forms 
CSR 
Clinical Study Report 
ED 
Emergency Department 
EMR 
Electronic Medical Record 
FDA 
United States Food and Drug Administration 
GSD 
Group Sequential Design 
ITT 
Intent-To-Treat Population 
IPTW 
Inverse Probability of Treatment Weighted 
NNM 
Nearest Neighbor Matching 
PP 
Per-Protocol Population 
PS 
Propensity Score 
PSM 
Propensity Score Matching 
PT 
Preferred Term 
SAE  
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOC 
System Organ Class 
SSRE 
Sample Size Re-estimation 
 
 
 
 
 

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2 SUMMARY 
TITLE 
Mitigation of Major Hip Injury due to fall in an At-Risk, Older Adult Population 
with a Wearable Smart Belt 
PREFACE 
This Statistical Analysis Plan (SAP) describes the planned analysis and reporting 
for Active Protective Technologies protocol COP-0001 (Mitigation of Major Hip 
Injury due to fall in an At-Risk, Older Adult Population with a Wearable Smart 
Belt). This study is being completed to assess the safety and efficacy of Tango® 
Belt for the treatment of the Tango Belt as an adjunctive intervention to the 
standard-of-care (SOC) to mitigate major hip injuries due to falls in an older 
adult population (65+ years of age) at-risk for fall injury. 
 
The following documents were reviewed in preparation of this SAP: 
 
Clinical Research Protocol COP-0001 v2.0, issued 18APR2022  
 
Case report forms (CRFs) Casebook Rev 1.0, annotated Rev.01 
PURPOSE 
The purpose of this SAP is to outline the planned analyses in 
support of the Clinical Study Report (CSR) for protocol COP-0001. 
Exploratory analyses not necessarily identified in this SAP may be performed 
to support the clinical development program. Any post-hoc, or unplanned, 
analyses not identified in this SAP will be clearly identified in the respective 
CSR. 
STUDY OBJECTIVES  
Primary Objective: To assess the performance of the Tango® Belt to mitigate 
fall-related major hip injuries in an at-risk-of-fall-injury adult population as 
compared to the standard of care (SOC) only.  
 
Secondary Objectives: To assess the performance of the Tango Belt to 
mitigate falls resulting in: (1) hip fractures, (2) emergency department (ED) 
visits or (3) hospitalizations. 
STUDY DESIGN 
Multi-center, comparative, non-significant risk adaptive study with historical 
controls.  
 
After providing informed consent and being screened for eligibility, 
intervention subjects will be prescribed and provided an appropriately sized 
Tango Belt. The subject must demonstrate a minimum of 64% adherence to 
the use of the Tango Belt within 14 days of initiation to fully enroll in the 
study. Upon demonstration of at least minimum adherence, the subject will be 
provided the Tango Belt to wear continuously for at least 6 months, except 
during bathing, device charging, and as deemed by clinical staff.  
 
The study will Investigate the safety and effectiveness of the Tango Belt with 
the primary and secondary endpoints being taken every 3 months and at the 
end of the study run time from the electronic medical record. Additionally, 
ancillary endpoints on adverse events and device performance will be 
gathered. 
ENDPOINTS 
Primary:  

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The study’s primary effectiveness endpoint is the proportion of major hip 
injuries due to fall in the subjects receiving SOC as compared to subjects 
receiving SOC plus the Tango Belt. 
 
There is no primary safety endpoint for this study. This is a non-significant risk 
study. Safety of the device will be determined by analysis of adverse events as 
an ancillary endpoint. 
 
Secondary:  
 
The study’s secondary endpoints include the proportion of each of the 
following: 
 
Hip fractures due to fall in the subjects receiving SOC as compared to 
subjects receiving SOC plus the Tango Belt. 
 
Emergency Department (ED) visits due to fall in the subjects receiving 
SOC as compared to subjects receiving SOC plus the Tango Belt. 
 
Hospitalizations due to fall in the subjects receiving SOC as compared 
to subjects receiving SOC plus the Tango Belt. 
 
Ancillary: 
 
Ancillary endpoints will include: 
 
Adverse events 
 
Major injuries due to fall 
 
Fall occurrence 
 
Device wear adherence 
 
Device fall alerts 
 
Device discrimination of serious hip-impacting vs. non-serious hip and 
non-hip impacting falls 
 
Airbag deployment 
 
Falls Efficacy Scale - International (FES-I) short version 
 
INTERIM ANALYSES 
The study will incorporate a group sequential design (GSD) in which an interim 
analysis will be performed to detect an 80% protective effect of the Tango Belt 
at 80% power at a planned interim analysis. If a significant difference is found 
between the prospective Tango Belt subjects and historical controls at the 
interim analysis, the study will be completed early.   
 
If not, enrollment will continue until a final sample size is reached to detect a 
60% protective effect of the Tango belt at 80% power and a 5% total level of 
significance.  
 
It was assumed subjects were followed for an average of 6 months, an annual 
fall-with-major-hip-injury rate of 15%, and sufficient historical control subjects 

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to allow 1:2 allocation of subjects to treatment and control. This would require 
94 subjects in the prospective Tango Belt group and 188 subjects in the 
historical control group at the interim analysis. Assuming a 30% attrition rate 
due to the fragile nature of this population, the samples sizes would increase 
to 134 and 268 in the prospective Tango Belt group and the historical control 
group, respectively. At the end of the study (should the higher effectiveness 
target not be achieved at interim analysis), 188 total subjects would be 
required in the prospective Tango Belt group and 376 subjects would be in the 
historical control group. Accounting for attrition, 268 and 536 in the 
prospective Tango Belt group and the historical control group, respectively. 
FINAL ANALYSES 
All final planned analyses identified in this SAP will be completed after the last 
subject has completed the End of Study visit and data entry has been finalized 
for all subjects used for analysis (including historical control subjects). 
3 STUDY OBJECTIVES AND ENDPOINTS 
3.1 STUDY OBJECTIVE 
The current comparative clinical study is intended to establish the safety and effectiveness of the Tango 
Belt as an adjunctive intervention to the standard-of-care (SOC) to mitigate major hip injuries due to 
falls in an older adult population at-risk for fall injury. 
3.1.1 PRIMARY OBJECTIVE  
To assess the performance of the Tango Belt to mitigate fall-related major hip injuries in an adult 
population at-risk of fall injury as compared SOC only. 
3.1.2 SECONDARY OBJECTIVE  
To assess the performance of the Tango Belt to mitigate falls resulting in: (1) hip fractures, (2) 
emergency department (ED) visits or (3) hospitalizations.  
3.2 STUDY ENDPOINTS   
3.2.1 PRIMARY ENDPOINT 
The study’s primary effectiveness endpoint is the proportion of major hip injuries due to fall in the 
subjects receiving SOC as compared to subjects receiving SOC plus the Tango Belt, as reported between 
enrollment and the 180-day visit. 
There is no primary safety endpoint for this study. Safety of the device will be determined by analysis of 
adverse events as an ancillary endpoint. 
3.2.2 SECONDARY ENDPOINTS 
The study’s secondary endpoints include the proportion of each of the following: 

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 
Hip fractures due to fall in the subjects receiving SOC as compared to subjects receiving SOC plus 
the Tango Belt. 
 
Emergency Department (ED) visits due to fall in the subjects receiving SOC as compared to 
subjects receiving SOC plus the Tango Belt. 
 
Hospitalizations due to fall in the subjects receiving SOC as compared to subjects receiving SOC 
plus the Tango Belt. 
The secondary endpoints will be assessed using data reported between enrollment and the 180-day 
visit. 
3.2.3 ANCILLARY ENDPOINTS 
Ancillary endpoints will include: 
 
Adverse events 
 
Major injuries due to fall 
 
Fall occurrence 
 
Device wear adherence 
 
Device fall alerts 
 
Device discrimination of serious hip-impacting vs. non-serious hip and non-hip impacting falls 
 
Airbag deployment 
 
Falls Efficacy Scale - International (FES-I) short version 
4 SAMPLE SIZE 
It is estimated that the sample size will include up to 268 subjects in the intervention group and up to 
536 subjects in the historical control group. This estimated sample size includes the minimum sample 
size required to assess the primary endpoint with an additional 30% increase to account for possible 
subject attrition. 
 
The sample size for the primary hypothesis will be calculated with 80% power. The annual rate of falls 
with major hip injury has been estimated between 6% and 10% in higher-risk populations within long-
term care facilities. Since the fall rate is not exactly known in the study population, the fall rate observed 
in the historical control group, a nuisance parameter, will be used for sample size calculations. After 
roughly 70% of subjects were enrolled into the historical control group, the proportion of subjects who 
experienced a major hip injury due to a fall was calculated to be 15% and this rate was used in the 
sample size calculation. 
 
The following steps were used to calculate the sample size (for further details, see section 10.1 of the 
Protocol): 
1. Test the historical control time periods to determine if all the time periods can be used, 
depending on if any time periods differ in fall rate 

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2. From the remaining historical control data, the fall rate was calculated and the total sample size 
available for the historical control group 
3. The sample sizes for the historical controls and the prospective Tango Belt arm at the interim 
analysis was calculated. 
4. The sample size for the prospective Tango Belt arm at the final analysis was calculated using the 
total sample of historical controls. 
 
This sample size determination was made based on the following specifications: 
 
Primary Effectiveness Endpoint Assumptions: 
The following assumptions were made for estimating sample size for the primary effectiveness 
endpoint: 
1. Alpha of 0.025 (one-sided) 
2. 80% power 
3. Groups are independent 
 
Based on the above assumptions, the minimum sample required for the intervention group for 
evaluation of effectiveness (unadjusted) is 94 subjects. At least 134 subjects will be enrolled to the 
intervention group to account for subject attrition and missing data (estimated to be 30%). 
 
4.1 INTERIM ANALYSES 
The study will incorporate a group sequential design (GSD) in which an interim analysis will be 
performed to detect an 80% protective effect of the Tango Belt at 80% power. If a significant difference 
is found between the prospective Tango Belt subjects and historical controls at the interim analysis, the 
study will be stopped, and the Tango Belt deemed superior to SOC alone.  If not, sample size re-
estimation will be completed, and enrollment will continue until a final sample size is reached to detect 
a 60% protective effect of the Tango Belt at 80% power and a 5% total level of significance.  
Following the steps from section 4, we assumed subjects were followed for an average of 6 months, an 
annual fall-with-major-hip-injury rate of 15%, and sufficient historical control subjects to allow 1:2 
allocation of subjects to treatment and control. This would require 134 subjects in the prospective 
Tango Belt group and 268 subjects in the historical control group at the interim analysis using the Pocock 
alpha-spending function as well as accounting for 30% attrition. At the end of the study (should the 
higher effectiveness target not be achieved at interim analysis), 268 total subjects would be required in 
the prospective Tango Belt group and 536 subjects would be in the historical control group. 
4.1.1 SAMPLE SIZE RE-ESTIMATION 
At the time of interim analysis, if the study is not stopped early for effectiveness, then sample size re-
estimation (SSRE) will be performed to calculate the final analysis sample size. The SSRE will be 
calculated the same way as was performed prior to the trial with the addition of a propensity score 
matching rate. This rate will account for the percentage of subjects that were in the Tango Belt 
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group. The annual fall-with-major-hip-injury rate will be updated using data from the 134 subjects in the 
Tango Belt treatment group as well. 
4.2 FINAL ANALYSES AND REPORTING 
All final, planned analyses identified in the protocol and in this SAP will be performed only after the last 
subject has completed the End of Study visit or if the stopping criterion is met at the interim analysis.  
Key statistics and study results will be made available following database lock. Any post-hoc, exploratory 
(ancillary) analyses completed to support planned study analyses, which were not identified in this SAP, 
will be documented, and reported as necessary. Any results from these unplanned analyses will also be 
clearly identified as post-hoc analyses. 
The Final Study Report is to be completed within 1 calendar month following the locking of the clinical 
database. 
5 ANALYSIS POPULATIONS 
5.1 HISTORICAL CONTROL POPULATION 
The Historical Control Population (HC) for this study includes retrospective subjects that meet all 
inclusion and exclusion criteria except for the waist circumference and need for consent. Eligible 
subjects’ electronic health records will be mined for the baseline, midpoint, and final study metrics. 
The investigator or a designee will retrospectively review the site's electronic medical record (EMR) 
database to determine long-term care patient population's eligibility for meeting the study inclusion 
criteria. The subjects in the clinical site census at the time frame 6 months prior to the IRB approval date 
will be screened for eligibility for study inclusion.  
If there is an insufficient number of eligible subjects to meet the control group target (defined as 2 times 
the expected number of intervention group subjects to be enrolled from the site) at 6 months prior to 
the intervention group start date, the EMR database screen will extend retrospectively in 6 month 
increments until the control group target is reached. 
5.2 INTERVENTION POPULATION 
Propensity score matching (described in section 7.1) will be used to match each treatment group subject 
with two subjects from the historical control group. If a subject from the treatment group is not included 
in any of the analysis populations described below, the historical control subjects they matched to using 
propensity scores will also not be included in any analysis comparing groups. 
5.2.1 INTENT TO TREAT POPULATION (ITT) 

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The ITT population will consist of all intervention population subjects who demonstrate at least 64% 
adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day 
for at least 9 of 14 days) and the propensity matched historical controls. 
5.2.2 PER-PROTOCOL POPULATION (PP) 
The per-protocol population (PP) will include all ITT subjects who additionally meet all study eligibility 
criteria, have available study data for the study endpoint and do not have a major protocol violation that 
affects primary effectiveness and the propensity matched historical controls. Major protocol violations 
are described in section 6.4.  
5.2.3 ADHERENCE POPULATION 
The adherence population includes all subjects in the PP population excluding those subjects who were 
not actually wearing Tango Belt when the primary effectiveness endpoint was experienced.  
5.2.4 SAFETY POPULATION 
The safety population includes all subjects who were assigned a Tango Belt and attempted the run-in 
period.  
6 GENERAL ISSUES FOR STATISTICAL ANALYSIS 
Descriptive statistics for continuous variables will be summarized using descriptive statistics (number of 
subjects, mean, median, quartiles, standard deviation [SD], minimum, and maximum). Categorical 
variables will be summarized using frequencies and percentages of subjects in each category. All results 
will be presented by treatment and appropriate subject populations. 
Statistical results such as confidence intervals and descriptive statistics for intervention primary 
effectiveness outcomes will be presented by site and in aggregate. Likewise, incidence of adverse events 
will be presented by site and in aggregate. 
P-values will be one-sided and considered significant at the 0.025 level, or two-sided and considered 
significant at the 0.05 level of significance. 
6.1 ANALYSIS SOFTWARE 
Analysis data sets, statistical analyses and associated output generated by Avania will be generated 
using SAS® Software version 9.4 or later and/or R version 4.2.0 or later.   
6.2 DISPOSITION OF SUBJECTS AND WITHDRAWALS 
6.2.1 INTERVENTION POPULATION 
The number and percent of subjects in each analysis population will be presented, with percentages 
based on the ITT population for the intervention group. The frequency and percent of subjects who 

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completed each scheduled assessment will be presented in a table. The number and percentage of ITT 
subjects prematurely withdrawing will be presented overall and by reason of discontinuation.  
6.2.2 HISTORICAL CONTROL POPULATION 
Due to the retrospective nature of the control group, only observed data will be used in analyses. 
Control subjects missing information will not be used in the Propensity Score (PS) analysis as there will 
be no imputation of missing data for the HC population. 
6.3 METHODS FOR WITHDRAWALS AND MISSING DATA 
All practical monitoring and follow-up steps will be taken to ensure complete and accurate data 
collection. Since endpoints are assessed at the 180-day visit, it is anticipated that there will be 
approximately 30% attrition. Given the disproportionately high rate of death and other loss-to-follow up 
reasons within this population, multiple imputation approaches will be carried out for missing primary 
endpoint data on the ITT population. The primary effectiveness analysis will be performed on data that 
has the primary outcome multiply imputed.  
6.3.1 MULTIPLE IMPUTATION 
Prior to propensity score matching, the intervention group may have missing information on the primary 
endpoint (i.e. major hip injury due to a fall), primarily due to premature withdrawal from the study. 
At the time of the final analysis, if more than 20% of data is missing for the primary endpoint reported at 
the 180-day visit, then the primary endpoint will be multiply imputed and the analysis from section 7.2 
will be repeated using both observed and multiply imputed data. 
For the multiple imputation, a total of 50 imputed datasets will be calculated (Graham et al.). Fully 
conditional specification (FCS) logistic regression will be used to impute missing major hip injury due to a 
fall status (primary endpoint) using the baseline covariates of age, sex, ethnicity, race, mobility level 
(Independent, Limited Assist, Supervision, Extensive Assist, or Total Dependence), BIMS Score, and FES-I 
score. 
The analysis for the primary endpoint will be carried out utilizing 50 datasets and then results will be 
combined using PROC MIANALYZE in SAS to obtain one overall test of significance. 
6.4 PROTOCOL DEVIATIONS 
Subjects with such non-compliance will be determined prior to database lock. Major protocol deviations 
will be summarized in the CSR.  This summary will include the number and percent of subjects (overall 
and by site) with each deviation type.  
 
Major deviations in this study include, but not limited to the following: 
 
 
Inadequate or delinquent informed consent  
 
Inclusion/exclusion criteria not met  
 
Unreported serious adverse events or fall event  

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 
Materially inadequate record keeping  
 
Intentional deviation from protocol, Good Clinical Practice, or regulations by study personnel  
6.5 MULTIPLE COMPARISONS AND MULTIPLICITY 
There is one primary effectiveness endpoint, and it will be compared between treatment groups at a 
one-sided 0.025 level of significance, adjusting for propensity score (PS). There are three secondary 
endpoints that will also be tested using propensity score adjusted test of proportions, and the type I 
error rate will be adjusted for multiple testing. 
 
To control type I error, the three secondary endpoints will be tested in a hierarchical, gatekeeping 
manner in the order specified below, each at a one-sided 0.025 level of significance, and only after the 
primary study effectiveness endpoint has been achieved in favor of the test treatment. Further, each 
secondary endpoint numbered 2 through 3 below will be tested for significance between treatments 
only if the previous secondary endpoint in the list has been shown to be significantly beneficial for the 
test treatment.  
 
This hierarchical closed test procedure is used to account for multiple testing with the goal of controlling 
the "maximum overall Type I error rate", which is the maximum probability that has been prespecified  
that one or more null hypotheses are rejected incorrectly, at a one-sided 0.025 level of significance. 
  
1. 
The proportion of Hip fractures due to fall in the subjects receiving SOC as compared to subjects 
receiving SOC plus the Tango Belt.  
2. 
The proportion of ED visits due to fall in the subjects receiving SOC as compared to subjects 
receiving SOC plus the Tango Belt. 
3. 
The proportion of Hospitalizations due to fall in the subjects receiving SOC as compared to 
subjects receiving SOC plus the Tango Belt. 
 
There will be no adjustment for multiple comparisons across any remaining effectiveness endpoints, nor 
will there be adjustment for multiple comparisons across ancillary endpoints. 
6.6 DEMOGRAPHICS 
Subject demographics and baseline characteristics for the Safety, ITT, and HC populations will be 
summarized in a table. Sex, race, ethnicity, and mobility level will be summarized with frequency and 
percent. 
 
Age will be summarized with number of observations, mean, median, minimum, maximum, and 
standard deviation. 
7 EFFECTIVENESS ANALYSES 

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Given that subjects in the two comparison groups (Tango Belt vs. SOC) are not randomized and thus may 
not have balanced baseline characteristics, Propensity Score (PS) matching will be carried out to adjust 
for measured baseline confounders prior to any statistical test(s) comparing treatments on effectiveness 
endpoints at the interim and final analysis. 
7.1 PROPENSITY SCORE METHOD 
For each subject, a PS (i.e., predicted probability between 0 and 1) of intervention group membership 
(Tango Belt vs. SOC) will be calculated using a logistic regression, with “intervention group” as the 
outcome and the following baseline variables as the predictors: Age, mobility level, sex, and whether the 
subject fell in the past year.  
Once propensity scores are calculated, propensity score matching (PSM) without replacement will be 
performed.  
Subjects in the intervention group (i.e., Tango Belt) will be matched to controls with a similar PS using 
nearest neighbor matching (NNM) at a ratio of 1:2.  
The PS modeling and design will be performed by a statistician who will be blinded to the endpoint data 
for each subject to avoid introducing bias into the analysis. The blinded endpoint data includes the 
primary and three secondary endpoints listed in section 3.2. 
Balance of baseline variables (e.g., continuous variable, dichotomous variable, interaction terms, or 
squares of continuous variable) will be assessed by comparing the pre-matched and post-matched 
datasets.  
Adequacy of propensity balance will be assessed by examination of standard differences between 
groups to confirm standard difference in post-matched dataset does not exceed 10%. Additionally, a 
comparison of the baseline covariate variables between groups after adjusting for propensity subgroup 
will be carried out as in D’Agostino et al. If the propensity matching is adequate, this will result in non-
significant p-values (p>0.05) for the baseline characteristics. 
Additional PS methods may be employed if group balance is not achieved by NNM, examples include 
covariate adjustment, inverse probability of treatment weighted (IPTW), etc. 
Since enrollment may be ongoing at the time of interim analysis, propensity score modeling and 
matching will be conducted at the interim analysis and subjects will be rematched at the time of the 
final analysis to ensure the best PS match possible. With PS matching possibly occurring twice the 
following differences in PS modeling and design may occur: 
1. Subjects may be matched to different control subjects. 
2. The number of matches (1:1 or higher – to a maximum of 1:4) may change based upon 
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3. The technique used to match (i.e., NNM) may change to another PS method to ensure adequacy 
of propensity balance. 
7.2 PRIMARY EFFECTIVENESS ANALYSIS 
The primary effectiveness endpoint for this study is the proportion of subjects experiencing major hip 
injuries due to falls, as reported at the 180-day visit and will be presented for the Tango Belt and control 
groups using the ITT and adherence populations. 
 
The proportion of subjects experiencing major hip injury due to falls is defined as the total number of 
subjects who experience a major hip injury due to a fall divided by the total number of subjects.  
 
The primary effectiveness hypotheses are: 
𝐻0: 𝜋𝑇 ≥ 𝜋𝐶 
𝐻1: 𝜋𝑇 < 𝜋𝐶 
 
where 𝜋𝑇 and 𝜋𝐶 are the proportion of subjects experiencing major hip injuries due to falls in the Tango 
Belt and control group, respectively. 
 
The null hypothesis (𝐻0) for this endpoint states that the true proportion of subjects using Tango Belt 
and experiencing major hip injuries due to falls is greater than or equal to the true proportion of 
subjects in the control group who experience major hip injuries due to falls. The alternative hypothesis 
(𝐻1) states that the true proportion of subjects using Tango Belt and experiencing major hip injuries due 
to falls is less than the true proportion of subjects in the control group who experience major hip injuries 
due to falls. 
The proportion of major hip injuries by treatment group will be presented along with a 95% confidence 
interval using the Clopper-Pearson method. 𝐻0 will be tested at a one-sided 0.025 level of significance 
using a logistic regression analysis to compare treatment groups while controlling for propensity score. 
7.3 SECONDARY EFFECTIVENESS ANALYSIS 
The secondary endpoints will also be tested using propensity score adjusted test of proportions with a 
hierarchical gate-keeping method to preserve the type I error rate (see section 6.5).  
The secondary effectiveness endpoints for this study include the following: 
1. The proportion of subjects experiencing fall-related hip fractures will be presented for the Tango 
Belt and control groups. 
2. The proportion of subjects experiencing ED visits due to falls will be presented for the Tango 
Belt and control groups. 
3. The proportion of subjects experiencing hospitalizations due to falls will be presented for the 
Tango Belt and control groups. 
 
The secondary endpoints will be assessed using data reported at the 180-day visit using the ITT 
population. 

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The proportion of subjects experiencing a secondary event will be assessed separately following the 
methodology in section 6.5 and are defined as follows: 
1. The proportion of subjects experiencing fall-related hip fractures is defined as the total number 
of subjects who experience fall-related hip fractures divided by the total number of subjects.  
2. The proportion of subjects experiencing fall-related ED visits defined as the total number of 
subjects who experience fall-related ED visits divided by the total number of subjects.  
3. The proportion of subjects experiencing fall-related hospitalizations defined as the total number 
of subjects who experience fall-related hospitalizations divided by the total number of subjects.  
 
The secondary effectiveness hypotheses are: 
𝐻0: 𝜋𝑇 ≥𝜋𝐶 
𝐻1: 𝜋𝑇 < 𝜋𝐶 
 
where 𝜋𝑇 and 𝜋𝐶 are the proportion of subjects experiencing a secondary event (i.e., hip fractures, ED 
visits & hospitalizations) due to falls is greater than or equal to the true proportion of subjects in the 
control group who experience a secondary event due to falls. The alternative hypothesis states that the 
true proportion of subjects using Tango Belt and experiencing a secondary event (i.e., hip fractures, ED 
visits & hospitalizations) due to falls is less than the true proportion of subjects in the control group who 
experience a secondary event due to falls. 
The proportion of secondary events (i.e., hip fractures, ED visits & hospitalizations) by treatment group 
will be presented separately along with a 95% confidence interval using the Clopper-Pearson method. 
𝐻0 will be tested at a one-sided 0.025 level of significance using a logistic regression analysis to compare 
treatment groups while controlling for propensity score. 
8 ADVERSE EVENTS 
8.1 ALL ADVERSE EVENTS 
The occurrence of all adverse event (AEs) will be documented for all subjects from the time of 
enrollment. Adverse Events will be categorized into three groups based on frequency: Single episode, 
Intermittent, or Continuous. This categorization is in lieu of other formal coding strategies (i.e., 
MedDRA). The final categorization of all AE’s will be performed by the Sponsor but general definitions 
are as follows: 
 
Single Episode: Any AE’s that occurred only once (Fall, death, etc.) as well as the first occurrence 
of an AE that occurs more than once. 
 
Intermittent: Subsequent AE’s beyond the first of each type. If a subject had more than one of 
the same AE (i.e., fall), all occurrences of that AE after the first one will be included in the 
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 
Continuous: Any AE’s that are ongoing and not resolved. Also, any AE that the subject lives with 
daily but doesn’t result in death. 
 
Summaries of incidence rates of individual AEs by frequency will be prepared. Because a subject may 
experience more than one AE per frequency, summaries will provide both the number of subjects 
experiencing at least one event and the number of events. Percentages provided will be the percent of 
subjects experiencing one or more adverse events. In addition, incidence of AEs will be presented by 
severity (mild, moderate, severe) and relationship to study device. 
 
Subjects experiencing an event within a given frequency more than once will be counted under the 
maximum severity/relationship experienced. 
 
A listing of all adverse events will include the subject number, date of onset, date of resolution, severity, 
AE type, the severity of AE, frequency of the event, the action taken, relationship to device, seriousness, 
and the outcome. 
 
An additional listing will be provided that includes both site reported and adjudicated information for 
AEs that are adjudicated. 
8.2 SERIOUS ADVERSE EVENTS 
Summaries of incidence rates and relationship to the investigational device of individual Serious Adverse 
Events (SAEs) by frequency will be prepared. Summaries will provide both the number of subjects and 
the number of events within the reporting period. Percentages provided will be the percent of subjects 
experiencing one or more serious adverse events.  A data listing of SAEs will also be provided, displaying 
details of the event(s) captured on the CRF.  
8.3 DEVICE RELATED ADVERSE EVENTS  
Summaries of incidence rates of device related AEs by frequency will be prepared. Summaries will 
provide both the number of subjects and the number of events within the reporting period. Percentages 
provided will be the percent of subjects experiencing one or more device or procedure related adverse 
events.  Data listings of device and procedure related AEs will also be provided, displaying details of the 
event(s) captured on the CRF. Relationship of the AE to the device will be judged by the investigator. 
Device relatedness categories include, not related, possibly related, probably related, and definitely 
related. 
8.4 DEATHS 
Should any subjects die during the course of the trial, relevant information will be supplied in a data 
listing. 

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9 SUMMARY OF CHANGES FROM THE PROTOCOL 
The following table provides a list of changes from the protocol to the SAP, and the justification for each 
change. 
Section 
Description 
Justification 
4. Sample Size 
Estimated attrition was changed from 
20% to 30% 
After roughly half the subjects in the 
Tango Belt group were exited, the 
attrition rate was reexamined and 
adjusted upwards to account for the 
higher-than-expected loss. 
4. Sample Size 
Historical Control rate of major hip 
injury estimate changed from 8% to 
15% 
The sample size estimate was revisited 
after it was clear that the expected 1:4 
allocation ratio was not attainable. The 
HC rate of major hip injury was also 
examined and deemed to be much higher 
than estimated at the beginning of the 
trial. 
10 REPORTING CONVENTIONS 
All reporting will meet the standards of SOP-68 AS Data Analysis Reporting and SOP-83 AS Programming 
Standards. 
11 REFERENCES 
1. Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some 
practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. 
2. D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment 
to a non-randomized control group. Stat Med. 1998 Oct 15;17(19):2265-81. 
3. Austin PC. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding 
in Observational Studies. Multivariate Behav Res. 2011 May;46(3):399-424.