A Pilot Study to Assess the Role of Accelera Stochastic Resonance Wearable Technology to Assist Gait and Mobility in the Older Adult
Conditions: Older Adults Who Use an Assistive Device for Mobility
Sponsor: Stony Brook University

 
 
 
 
 
 
 
A Pilot Study to Assess the Role of Accelera 
Stochastic Resonance Wearable Technology to 
Assist Gait and Mobility in the Older Adult 
 
10/5/2025 
 
 
 
 
 
 
 
 
 

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PROTOCOL TEMPLATE FOR INVESTIGATOR-INITIATED STUDIES 
  
 INSTRUCTIONS: 
-        Sections will expand to fit your responses. 
-        Keep an electronic copy to modify when making changes either as directed by the IRB, 
or for amendments/modifications.  
-        Mark sections “NA” if they are not applicable to your research. 
-        Please use lay language, avoid professional jargon and define all abbreviations when 
they first appear. 
  
PROTOCOL TITLE: 
Response: A Pilot Study to Assess the Role of Accelera Stochastic Resonance Wearable 
Technology to Assist Gait and Mobility in the Older Adult 
PROTOCOL VERSION/AMENDMENT # AND DATE 
Response: Version 4 - 10/05/25 
  
PRINCIPAL INVESTIGATOR: 
Response: Principal Investigator: Randeep Jawa, MD  
Co-investigator: Jennifer Hensley, MD 
  
1.0 Objectives 
1.1  
Describe the purpose, specific aims, or objectives of this research. Specifically, explain 
why it is important to do the study. 
Response: This research aims to evaluate the impact of subtle vibrations applied to the ankles, 
on gait and mobility in older adults. Participants will not consciously perceive the vibrations after 
initial set-up. More specifically-  
● Impact of device on gait and mobility 

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● Older adults’ perception of device function, wearability, and impact on mobility 
confidence 
  
2.0 Background 
2.1  
Provide the scientific or scholarly background, rationale, and significance of the research 
based on the existing literature and how it will contribute/fill in gaps to existing knowledge. 
 
Response: The research protocol outlines the evaluation of stochastic resonance (SR) ankle 
bracelets in improving mobility in older adults.  The concept is that improved mobility would be 
associated with reduction in falls. Falls in the elderly are a significant public health concern, 
being the leading cause of injury, hospitalization, and death in this population. Although the 
elderly make up about 12% of the U.S. population, they account for 75% of deaths related to 
falls. Approximately one in four individuals over the age of 65 experience a fall annually, with 
many falling more than once. The healthcare costs associated with falls are staggering, with 
current estimates of combined direct and indirect costs exceeding $80 billion. Contributing to 
these costs are hospital stays, medical equipment, and rehabilitation, which underscores the 
need for effective preventative measures. The risk factors for falls among older adults include 
vision problems, muscle weakness, and a decline in somatosensory function. Among these, the 
loss of tactile and proprioceptive sensations has been identified as a critical predictor of falls. 
Stochastic resonance (SR) is a phenomenon where the addition of a certain level of noise can 
enhance sensory signal detection. In this context, SR-based devices, such as vibrating insoles, 
have been explored for their potential to improve balance and reduce postural sway, which 
could ultimately reduce fall risk in elderly populations. 
Previous studies have shown promising results. For example, SR has been shown to enhance 
tactile sensation in human subjects. Later studies extended this work, demonstrating that SR 
could reduce the sensory detection threshold in elderly individuals and those with conditions like 
diabetic neuropathy and stroke. Further investigation of SR insoles participants found that the 
insoles reduced postural sway in the elderly. These results suggest that SR could be an 
effective tool for enhancing mobility and in association reduce falls in older adults. Despite these 
promising findings, important questions remain unanswered. 
2.2  
Include complete citations or references: 
Response: 
1.     Center for Disease Control and Prevention. Falls Among Older Adults: An Overview. December 8, 
2010. Accessed October 24, 2024. http://www.cdc.gov/HomeandRecreationalSafety/Falls/adultfalls.html. 
2.      Collins JJ, Imhoff TT. Noise enhanced tactile sensation. Nature. 1996;383:770-771. 

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3.     Fuller GF. Falls in the elderly. Am Fam Physician. 2000;61(7):2159-2168. Accessed October 24, 
2024. http://www.aafp.org/afp/20000401/2159.html. 
4.     Galica AM, Kang HG, Priplata AA, et al. Subsensory vibrations to the feet reduce gait variability in 
elderly fallers. Gait Posture. 2009;30(3):383-387. 
5.      Hawryluk M. Fall-related injuries cost Medicare billions. Amednews.com. December 16, 2002. 
Accessed October 24, 2024. https://www.ama-assn.org. 
6.      Liu WM, Lipsitz L, Montero-Odasso M, et al. Noise-enhanced vibrotactile sensitivity in older adults, 
patients with stroke, and patients with diabetic neuropathy. Arch Phys Med Rehabil. 2002;83:171-176. 
7.     Owens PL, Russo CA, Spector W, Mutter R. Emergency department visits for injurious falls among 
the elderly, 2006. HCUP Statistical Brief #80. Agency for Healthcare 
8.     Research and Quality. October 2009. Accessed October 24, 2024. http://www.hcup-
us.ahrq.gov/reports/statbriefs/sb80.pdf. 
9.     Priplata A, Niemi J, Harry J, Lipsitz L, Collins J. Vibrating insoles and balance control in elderly 
people. Lancet. 2003;362(9390):1123-1124. 
10.  Priplata A, Patritti B, Niemi J, et al. Noise-enhanced balance control in patients with diabetes and 
patients with stroke. Ann Neurol. 2006;59:4-12. 
11.  United States Census Bureau. Sixty-Five Plus in the United States. May 1995. Accessed October 24, 
2024. https://www.census.gov. 
12. Haddad YK, Miller GF, Kakara R, Florence C, Bergen G, Burns ER, Atherly A. Healthcare 
spending for non-fatal falls among older adults, USA. Inj Prev. 2024 Jul 19;30(4):272-276.  
  
 3.0 Study Design 
3.1  
Describe and explain the study design (e.g., case-control, cross-sectional, ethnographic, 
experimental, interventional, longitudinal, and observational). Indicate if there is randomization, 
blinding, control group, etc. If randomizing, explain how this will be achieved. 
This is a pilot, observational study with 20 volunteers at Jefferson’s Ferry Independent Living. 
Before the Accelera ankle bracelets are applied, participants will complete a pre-study 
questionnaire. They will then complete 3 tests that the Centers for Disease Control (CDC) 
recommends for fall risk assessment, namely the chair stand test, 4-point balance test, and 
timed up and go test, while using their usual mobility assist devices.  If the participants provide 
optional consent, they will undergo video-based gait/mobility analysis of information derived 
from the HIPAA compliant Onform video recording app, while they are using their usual mobility 

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assistance devices, if any. In other words, a video recording is made with the app and stored on 
the apps’ HIPAA compliant platform.  With the faces obscured, measurements of their 
gait/mobility will be performed using additional programs as indicated in the Data section.  After 
bracelet application, volunteers will then be encouraged to resume their normal ambulation` 
(while using their usual mobility assistive devices) for about 30 minutes at the study location as 
described below. The same 3 tests will be repeated after 30 minutes, along with a post-study 
questionnaire, and if they consented to video recording above, then repeat videorecording with 
the Onform video recording app would be performed. With the faces obscured, measurements 
of their gait/mobility will be performed using additional programs as indicated in the Data 
section. At this point, the ankle bracelets will be removed – with the subjects having worn them 
for about 1 hour total. There will be an additional up to 1 hour for completion of the pre- and 
post-study questionnaires, for a total study session duration of about 1.5 - 2 hours.  At each 
session, we will apply these bracelets to a minimum of 1 patient per session.  These sessions 
will occur at the Wellness Center/gym or other designated area at Jefferson’s Ferry 1x per 
week, with a minimum of one patient for up to 8 patients/week if no holidays, until 20 patients 
have completed the study. To address infection control, a disposable sock will provide a 
physical barrier between the device and patient, while still allowing the patient to feel the 
stochastic resonance. 
  
3.2  
Include the number of subjects and the power analysis. If applicable, indicate your 
screen failure rate, i.e., how many subjects you expect to screen to reach your target sample.  
Response: 20 volunteers will be enrolled.  The study would continue until 20 volunteers are 
enrolled and complete all non-optional parts of the single study session. 
  
3.3  
Indicate the duration of the subject participation including long-term follow-up. 
Response: A single study session.  There is no long-term follow-up in this study. 
  
3.4  
Indicate whether you are specifically recruiting or targeting any of the following special 
populations in your study using the checkboxes below. 
Response: n/a 
☐    
Minors (under 18 years old) 
☐    
Adults unable to consent 
☐    
Pregnant women 

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☐    
Prisoners 
  
3.5  
Indicate if you will include minorities (American Indians, Alaskan Native, Asian, Native 
Hawaiian, Pacific Islander, Black [not of Hispanic origin] and Hispanic) as Federal mandates 
require that you include minorities unless you can justify their exclusion. 
Response: 
☒    
Yes 
☐    
No, Justify: 
  
3.6  
Indicate whether you will include non-English speaking individuals in your study.  
Provide justification if you will specifically exclude non-English speaking individuals. Review 
https://www.stonybrook.edu/research-compliance/Human-Subjects/sops for the SBU policy on 
inclusion of non-English speakers (section 17.8). Following approval of the English version, you 
must submit the translated version of the materials with the attestation of the translation. 
Response: Non-English speakers will be excluded to assure understanding of verbal 
instructions in English as well as enable completion of the survey. 
  
3.7  
Describe the data analysis plan, including any statistical procedures. 
NOTE: If we are a lead site for a multi-site study include the total number of subjects that will be 
enrolled, or records that will be reviewed across all sites. This section applies to both 
quantitative and qualitative analysis. 
Response: The data of participants who meet the inclusion criteria will be collected during study 
visits and recorded directly by study staff. Only the consents will have the participant’s names.  
There will be no linking of the participant to subject ID.  Hence, all data will be de-identified and 
stored using unique study identifiers to protect participant privacy. The data will be securely 
stored on password-protected, encrypted servers at Stony Brook Medicine to ensure 
compliance with privacy and confidentiality standards. 
If the participants choose to have their mobility evaluated by the research team with the video 
recording app, then their videos would be uploaded to the HIPAA compliant platform of the app.  
The first name used for the app would be the 1st digit of their assigned code and the last name 
would be the last digit of their assigned code.  Their faces would be obscured by taking a video 
from the chin/neck down. 

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Descriptive Analysis: 
Descriptive univariate statistics will be conducted to summarize the demographic and 
performance characteristics of the study population, including device sensory thresholds, 
gait/mobility using a mobility videorecording app (optional, see below) before and while wearing 
the ankle bracelets, pre- and post-study questionnaires, and performance before and while 
wearing the ankle bracelets on the 3 CDC STEADI tests (the chair stand test, 4 point balance 
test, and timed up and go test).  Multivariate analysis would also be performed. 
 
Videos uploaded on the Onform app with participants’ faces obscured would then be analyzed 
with additional feature extraction, analytics, and statistical programs.  This would include optical 
character recognition programs to analyze the joint angles numbers that the video recording 
provides.  Outside of the app, parts of the video will be cropped, the stick figure that the 
Onform app generates will be highlighted, and the contrast and lighting of the video will 
be adjusted to make the subject look like a shadow, ie s no features of the subject (such 
as clothing, gender, skin color, etc.) can be recognized.  Programs such as ImageJ will be 
used for feature extraction. Python/R will be used to pull the data from the videos/cropped 
images.  Python/R/excel will be used for statistical analysis of gait/mobility parameters, such as 
joint angles, stride time, stance time, swing time, cadence, stride length, step width, and 
foot angle, etc 
  
  
4.0 Inclusion and Exclusion Criteria 
NOTE:  If your study is more than minimal risk, you must also upload (in the myResearch IRB 
smartform) a copy of your inclusion/exclusion checklist to be completed at time of enrollment of 
each subject. 
  
4.1  
Describe, in bullet points, the criteria that define who will be included in this study. 
Response: Please see inclusion/exclusion attachment for details.  In brief, however:   
• Adults aged 65+ years who reside at Jefferson’s Ferry independent living.  
• Express interest in the ankle wearable device.   
• Individuals who can communicate in English and provide written consent. 
•They must have capacity as measured by being alert and oriented to person, place, and time. 
• Participants are able to walk and stand unsupported by others and feel ankle vibrations from 
the Accelera device at maximum amplitude.  

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• Answer Yes to at least one: worry about falling, had a fall within last year, feel unsteady when 
walking, limit activity due to fear of falling, enrolled in a fall prevention program, or use or have 
used assistive devices for ambulation (e.g. canes or walkers).   
  
4.2  
Describe, in bullet points, the criteria that define who will be excluded from this study. 
Response: Please see inclusion/exclusion attachment for details.  In brief, however:    
 
• Patients diagnosed with neurodegenerative diseases (such as Parkinson’s, Alzheimer’s, or 
ALS)  
• Any lower extremity amputation other than one toe 
• Disability from a stroke or other major neurologic disorder resulting in leg paralysis  
• Active ulcers/rashes/infections on feet or legs, or using orthotics other than arch supports or 
over the counter knee/ankle supports 
• Significant lymphedema/peripheral edema/or large ankle size that prevents ankle wearable 
device application or functionality 
• Unable to participate due to other medical or cognitive reasons.  
• Cannot give written consent. 
• Cannot walk today or generally use wheelchairs 
• On anticoagulants or antiplatelet agents other than aspirin 
• Age under 65 years 
 
** Individuals with any active infection and/or currently receiving prescribed antimicrobial 
agent(s) will be asked to return when infection is resolved.   
  
4.3  
Describe how individuals will be screened for eligibility.  Upload all relevant screening 
documents with your submission (screening protocol, script, questionnaire). Identify who will 
certify that subjects meet eligibility requirements. (Upload these documents in the myResearch 
IRB smartform.) 
Response: Participants who are interested will be able to sign up at their discretion after the 
study is presented to the Jefferson’s Ferry community.  
To be included, please see detailed inclusion/exclusion criteria attachment.  However, in brief 
they will need to:  
● Answer Yes to at least one: worry about falling, had a fall within the last year, feel 
unsteady when falling, enrolled in a falls prevention program (past and/or present), or 
use in the past year of assistive devices for ambulation (e.g. canes and/or walkers)  
● Are you willing to wear a device on both ankles for up to 1 hour at a time?  
● Are you able to commit to completing the pre and post study questionnaire, 3 mobility 
tests before and while wearing the ankle bracelets. 

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● The intake form will also contain additional demographic questions (see attached). 
 
 5.0 Vulnerable Populations 
5.1  
For research that specifically recruits/targets minors (under 18 years), review, complete 
and upload Supplemental Form F: Minors. 
☐    
Confirmed 
☒    
N/A:  This research does not involve persons who have not attained the legal age for 
consent to treatments or procedures (“children”). 
  
5.2  
For research that specifically recruits/targets adults who cannot consent for themselves, 
you will be asked additional information in Section 25 (“Informed Consent”). 
☐    
Confirmed 
☒    
N/A: This research does not involve this population. 
  
5.3  
For research that specifically recruits/targets pregnant women, review, complete and 
upload Supplemental Form A:  Pregnant Women, Fetuses, Non-Viable Neonates, or Neonates 
of Uncertain Viability. 
☐    
Confirmed 
☒    
N/A:  This research does not involve pregnant women. 
  
5.4  
For research that specifically recruits/targets neonates of uncertain viability or non-viable 
neonates, review, complete and upload Supplemental Form A:  Pregnant Women, Fetuses, 
Non-Viable Neonates, or Neonates of Uncertain Viability. 
☐    
Confirmed 
☒    
N/A: This research does not involve non-viable neonates or neonates of uncertain 
viability. 
  

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5.5  
For research that specifically recruits/targets prisoners, review, complete and upload 
Supplemental Form B: Prisoners. 
☐    
Confirmed 
☒    
N/A: This research does not involve prisoners. 
  
5.6  
Consider if other specifically targeted populations such as students, employees of a 
specific firm, or educationally or economically disadvantaged persons are vulnerable.  Provide 
information regarding their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Safeguards include: 
 ☒ 
N/A: This research does not involve these populations. 
  
6.0 Recruitment Methods 
☐    
N/A: This is a records review only, and subjects will not be recruited. 
NOTE: If you select this option, please make sure that all record review procedures and 
inclusion/exclusion screening are adequately described in other sections, including date range 
for records that will be reviewed. 
6.1  
Describe source of subjects: When, where, and how potential subjects will be recruited. 
In order to approach patients in the clinic/hospital setting you must have a treatment relationship 
with these individuals. 
NOTE: Recruitment refers to how you are identifying potential participants and introducing them 
to the study. 
Response: Participants for this pilot study will be older adults (age>=65 years) living at 
Jefferson’s Ferry Independent Living, who use or have used an assistive device for ambulation 
in the past year, who are interested in trying this technology, and meet detailed 
inclusion/exclusion criteria evaluation as per the checklist.  Before enrollment, as a part of 
Jefferson’s Ferry monthly meeting calendar, it will be indicated that an in-person educational 
session on this proposed study will be held. Study team members will then provide an 
educational session at Jefferson’s Ferry to describe the study and invite eligible residents to 
participate.  As the plan is to conduct enrollment and study sessions on one day of the week 

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(tentatively Mondays), excluding holidays or other institutional/researcher obligations, those 
interested would also be advised that they can stop in on study days for screening/enrollment.   
  
6.2  
Describe how you will protect the privacy of prospective subjects during the recruitment 
process.  
NOTE:  Examples of appropriate responses may include: “participant only meets with a study 
coordinator in a private office setting where no one can overhear”, “the participant is reminded 
that they are free to refuse to answer any questions that they do not feel comfortable 
answering.”  
Response: During the recruitment and screening process, participants' privacy will be protected 
by ensuring that all recruitment activities occur in a confidential manner. This includes 
discussion of recruitment and consent in a private consultation room at Jefferson’s Ferry. 
Interested individuals will contact the study staff directly to express interest. Personal 
discussions regarding the study will take place in private settings, in person, to ensure privacy. 
Only authorized research staff will be involved in the recruitment and screening process. There 
is only 1 educational session planned.  We would have a sign-up sheet for those who are 
interested at the end of the session and provide them with information about when the study 
sessions will be taking place so they can further assess interest and eligibility.  People 
interested can also come to the Wellness Center on days that the study is being performed to 
express their interest. 
In addition, all participant information collected during the subsequent screening process will be 
de-identified and stored securely. The research team will use a unique identifier for each 
participant, and all identifiable information (i.e. the consents) will be kept in locked cabinets 
accessible only to designated research personnel until it and the other forms can be uploaded to 
the University’s secure share drive system. At that point, the physical copies will be destroyed.  
Furthermore, electronic records will be stored on password-protected, encrypted Stony Brook 
Medicine servers to prevent unauthorized access. 
  
7.0 Research Procedures 
7.1  
Provide a detailed description of all research procedures or activities being performed on 
the research subjects. This should serve as a blueprint for your study and include enough 
detail so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the addition of a 
schedule of events table in in your response. Be sure to include: 
·                 Procedures being performed to monitor subjects for safety or to minimize risks. 

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·                 All drugs and devices used in the research and the purpose of their use, and their 
regulatory status 
Response: The intervention involves the collection and analysis of data from older adults (age 
65+) living at Jefferson’s Ferry independent living to evaluate the effects of stochastic 
resonance (SR) ankle wearables on gait and mobility. The device will be applied during a study 
session lasting about 1.5-2 hours, where about 1 hour is spent on completing the pre- and post-
study questionnaires on pen/paper.  The other 1 hour is spent on the various gait and mobility 
evaluations before and while wearing the device, as detailed below.   
At the visit, after completing the pre-study questionnaire, participants will perform 3 tests 
validated by the CDC for fall risk screening: the timed up and go test, 30-second chair stand, 4 
stage balance test.  If the participants opt in to mobility analysis performed with the Onform 
iPad/iPhone video recording app without the participant’s name, rather than with a code, then 
this would be performed.  As indicated above, participant’s faces will be obscured. The ankle 
bracelets will then be applied. After about 30 minutes of resuming their usual ambulation in the 
observation area as below, the same 3 tests would be repeated as well as if they had opted in 
above, repeat mobility video recording with the Onform app, all while the ankle bracelets are in 
place.  The ankle bracelets will be removed after completion of the session.  Before application 
of the Accelera device and while they are wearing the Accelera device, the participants will be 
asked to continue to use their usual mobility assistive devices as they usually do.  The post 
study questionnaires will then be completed.  All questionnaires will be completed with 
pen/paper. 
There will generally be 1 session per week at Jefferson’s Ferry, at the Wellness Center/gym or 
other designated area at Jefferson’s Ferry, with a minimum of one patient for up to 8 
patients/week if no holidays, until 20 patients have completed the study.  It is currently 
tentatively planned for Mondays, excluding holidays and other institutional/researcher 
availability requirements.  However, this may be adjusted in coordination with Jefferson’s Ferry. 
Possible participants will be able to sign up at the educational session for additional information.  
Additionally, they will be advised that they can come sign up at any date that we are having a 
study session.  They would only complete the screening/survey questionnaires at a study 
session. 
If the participants opt in, then the app that will be used for mobility analysis during the study is 
called Onform, from Onform Inc. It is a HIPAA compliant video recording and analysis App.  The 
video recording that is saved will be saved as per the app specifications using a first and last 
name, however the first name will be the 1st digit of the subject ID code, and the last name will 
be the last digit of the subject ID code. As indicated above, participants’ faces will be obscured.  
Analysis will be as described in section 3.7 above.  Please see the attached app privacy policy. 
 

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7.2  
Describe what data, including long-term follow-up data, will be collected.  
NOTE: For studies with multiple data collection points or long-term follow-up, consider 
the addition of a schedule or table in your response. 
Response: The data being analyzed includes participant pre and post study questionnaires, 
including demographics, sensory thresholds for the Accelera device, 30-second chair stand, 4 
stage balance test, and timed up and go (TUG) task outcomes.  There will also be 
mobility/gait/posture analysis performed via an iPad/iPhone App without the participant’s name 
before and while wearing the ankle bracelets. Researchers will provide basic prompts regarding 
participants' stability and gait. Participants will also complete a self-reported health/exercise/fear 
of falling questionnaire at the start of the visit and at the end of the visit as well as a post 
questionnaire. We will also evaluate for falls with or without the device at the study session.  
There is no long-term follow-up. 
  
7.3  
List any instruments or measurement tools used to collect data (e.g., surveys, scripts, 
questionnaires, interview guides, validated instruments, data collection forms). Upload these 
materials in the myResearch IRB smartform. 
Response: Participants will complete a self-reported health/exercise/fear of falling/mobility 
questionnaire as detailed above during the index visit and at the start and end of the study 
session.  Their performance on the above 3 CDC tests (the chair stand test, 4-point balance 
test, and timed up and go test) will be measured and recorded using the CDC defined 
evaluation tool before and while wearing the ankle bracelets.  If the participants opted in, then 
we will also perform gait/mobility analysis with the HIPAA compliant Onform app, as indicated 
above in section 3.7, before and while wearing the ankle bracelets. We will also measure 
sensory thresholds for the Accelera device.  Finally, we will also evaluate for falls with or without 
the device at the study session.  
7.4  
Describe any source records that will be used to collect data about subjects (e.g., school 
records, electronic medical records) and include the date range for records that will be 
accessed. 
Response: Participants will be asked to list their medical histories in the questionnaire indicated 
above, assistive device use, and fall history/fear of falling. The study team will not access any 
patient medical records.  Please see attachment for detailed intake form questions. 
  
7.5  
Indicate whether or not the results for individual subjects, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be shared with subjects 
or others (e.g., the subject’s primary care physician) and if so, describe how these will be 
shared. 

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Response: The participants will be advised of their performance on the 3 CDC tests (the chair 
stand test, 4-point balance test, and timed up and go test) before and while wearing the ankle 
bracelets, their responses on the pre and post questionnaires as well as mobility/posture/gait 
analysis app findings if participants want to review these. 
  
8.0 Research Setting 
8.1  
Describe all facilities/sites/locations where you will be screening and conducting 
research procedures.  
Example: “A classroom setting in the Department of Psychology equipped with a computer with 
relevant survey administration software,” “The angiogram suite at Stony Brook University 
Hospital, a fully accredited tertiary care institution within New York State with badge access,” 
etc. 
Response: Jefferson’s Ferry Independent Living at the Wellness Center/gym or other area as 
designated by Jefferson’s Ferry 
  
8.2  
For research procedures being conducted internationally), Supplemental Form C must 
be completed and uploaded. 
Response: 
☒    
N/A: This study is not conducted outside of SBU or its affiliates. 
  
8.3  
For research procedures conducted externally to Stony Brook University (e.g. other 
institutions, schools, other states), attach applicable approval letter(s) in the myResearch IRB 
smartform. 
Response: Please see attached approval letter from Jefferson’s Ferry. 
  
9.0 Resources and Qualifications 
9.1  
The Principal Investigator (PI) must confirm, in consultation with Chair and Dean as 
applicable, that adequate resources are present to conduct and complete the study compliantly 
and safely. Specifically: 

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☐ NO        
☒YES       
 The proposed subject population(s) are available in sufficient 
numbers to meet the study requirements. 
☐ NO        
☒YES      Sufficient funds are available to conduct and complete the study 
compliantly and safely. 
☐ NO        
☒YES       
 The PI and study team have sufficient time to conduct and 
complete the study compliantly and safely. 
☐ NO        
☒YES       
 The PI has determined that the named study team is qualified to 
conduct the research compliantly and to monitor the safety and welfare of the enrolled research 
subjects effectively. 
☐ NO        
 ☒YES The PI ensures that the study team is fully aware of his/her involvement 
in this study and the details of the study protocol. 
☐ NO        
 ☒YES The PI ensures that the study teams will only be involved in research 
procedures for which they have been trained, and are currently certified and/or licensed, if 
required. 
☐ NO        
☒YES The PI ensures that all study team members are updated on the progress 
of the research and the regulatory requirements (including enrolled subjects, unanticipated 
problems, etc.). 
Response: 
  
10.0 Other Approvals 
10.1 
 List approvals that will be obtained prior to commencing the research (e.g., University 
Hospital signoffs per the UH Application, Cancer Center Scientific review, external site, funding 
agency, laboratory, Radiation Safety, IBC, SCRO, IACUC, RDRC). 
Response: 
  
☒ N/A: This study does not require any other approval. 
  
  
11.0 Provisions to Protect the Privacy Interests of Subjects 

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11.1 
Describe how you will protect subjects’ privacy interests during the course of this 
research. 
NOTE: Privacy refers to an individual’s desire/right to control access to or to place limits on 
whom they interact with or whom they provide personal information.  Privacy applies to the 
person.  Examples of appropriate responses include: “participant only meets with a study 
coordinator in a private office setting where no one can overhear”, or “the participant is 
reminded that they are free to refuse to answer any questions that they do not feel comfortable 
answering.”  
Response: The participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering. Participants will only meet with a study coordinator in a 
private consultation room at Jefferson’s Ferry. 
  
12.0 Confidentiality 
A. Confidentiality/Security of Study Data 
  
Describe the local procedures for maintenance of security and confidentiality of study data and 
any records that will be reviewed for data collection.  
  
NOTE: Confidentiality refers to how data collected about individuals for the research will be 
protected by the researcher from release. Confidentiality applies to the data. 
  
12.1 
Where and how will all data and records be stored?  Include information about locked 
cabinet/locked office, authorization of access, certificates of confidentiality, and separation of 
identifiers and data, as applicable.  Include physical (e.g., paper) and electronic files (e.g., 
storage of data in REDCap) password protection, encryption. 
Response: All data and records will be stored locally on secure Stony Brook Medicine networks. 
The only identifying data is the consent form.  However, this will not be linked to the unique 
random study code/participant id number. The data will be collected during study visits and de-
identified, with participant identifiers being replaced by unique study codes. The de-identified 
data will be encrypted and securely stored on Stony Brook Medicine encrypted servers, which 
meet institutional security standards. Access to the data will be restricted to authorized 
personnel, with password-protected systems and encryption in place to ensure data security. 
Additionally, all identifiable information, such as consent forms will be uploaded to a secure 

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Stony Brook Medicine shared drive and then disposed in the secure Health Sciences Center 
(HSC) discard bin.  
The optional Onform app video recordings will be stored on the apps HIPPA compliant platform.  
The face will be obscured. 
The physical forms (i.e. pre and post questionnaires, performance on the app, CDC tests, 
device sensory thresholds) will be transported to SBUH by research personnel and will be 
stored separately in a secured, locked file cabinet until they can be uploaded (scanned) into the 
secured shared drive, at which point all physical forms will be discarded in the Stony Brook 
Medicine HSC secure bins.  Answers to the study questionnaires, performance on the 3 CDC 
tests as well as gait analysis app findings, Accelera device sensory thresholds, will also be 
entered into an excel sheet on the Stony Brook Medicine shared drive. 
  
12.2 
Who will have access to the data? 
Response: Access to the data will be restricted to the Principal Investigator and the designated 
research staff involved in the study, including research assistants, data managers, and 
statisticians.  Accelera company will only have access to the aggregate data from the study. 
NOTE: If there are plans to share datasets with unrestricted access, adjust language in the 
consent form to reflect this. Consider including the phrase: “Your data and biospecimens will be 
shared in a way where anybody around the world can gain access to them without review.” 
  
12.3 
How will the data be transported/transmitted (if applicable)? 
Response:  Data will be transported and transmitted securely using password-protected, 
encrypted spreadsheets. De-identified electronic files will be stored on Stony Brook Medicine 
networks. For data sharing with collaborators, including the study sponsor Accelera, deidentified 
data will be transmitted via encrypted emails.  
Videos/data collected via the Onform app platform is maintained on the apps’ HIPAA compliant 
platform. 
  
12.4 
Describe if identifiers will be retained, de-identification of the data is not feasible, or 
whether there are circumstances in which re-identification may be possible. 
Response: De-identified data will be stored separately from any identifying information, which 
will be encrypted and stored in a separate, secure file to ensure confidentiality. Participants’ 

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faces will be obscured in the video recordings on the Onform app.  Only authorized study 
personnel will have access to the data. 
 
12.5 
If this study includes data collected from individuals, groups, or populations with unique 
attributes (e.g., Tribal Nations, international sites) that may increase the risk of re-identification, 
describe how sensitive information regarding potentially stigmatizing traits, illegal behaviors, or 
other information that could be perceived as causing group harm or used for discriminatory 
purposes will be protected. 
Response: n/a 
  
12.6 
Describe circumstances under which a code key may be used to re-link identifying 
information to data/specimens? 
Response: n/a 
  
B. Confidentiality of Study Specimens 
  
Describe the local procedures for maintenance of confidentiality of study specimens.    
☐    
N/A: No specimens will be collected or analyzed in this research.  
  
12.7 
Where and how will all specimens be stored?  Include information about: locked 
freezers, locked laboratories, authorization of access, and labeling of specimens, as applicable.  
Response: n/a 
  
12.8 
Are there limits for the future use of biospecimens in any way? Such as controlled 
access to the data based on laws, regulations, policies, and agreements. 
Response: n/a 
  

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12.9 
Who is responsible for receipt or transmission of the specimens (if applicable)? If you 
are transporting specimens to another location not affiliated with Stony Brook University, you 
must have a Material Transfer Agreement. 
Response: n/a 
  
12.10 Banking Data or Specimens for Future Unspecified Use 
☒    
N/A: This study is not storing data or specimens for research outside the scope of the 
present protocol.  This section does not apply. 
NOTE: If you are proposing to bank specimens for future use, you may be subject to licensure 
requirements under the NYS Department of Health and must be covered under the SBU 
license. See SOPs section 17.2 at https://www.stonybrook.edu/research-compliance/Human-
Subjects/sops. 
  
12.11  If data will be banked for research outside of the scope of the present protocol, describe 
where the data will be stored, how long they will be stored, and who will have access to the 
data. 
NOTE:  Your response here must be consistent with the information provided to subjects in your 
Consent Documents 
Response: 
  
12.12 Will specimens be obtained from specific cultural groups? Consider whether your study 
will include specimens collected from individuals, groups or populations with unique attributes 
(e.g., Tribal Nations, international groups) that may increase the risk of re-identification. 
Describe how sensitive information regarding potentially stigmatizing traits, illegal behaviors, or 
other information that could be perceived as causing group harm or used for discriminatory 
purposes will be protected. 
  
Also, consider cultural sensitivities around the return and/or destruction of biospecimens when 
research participants withdraw their consent for the storage and sharing of data and 
biospecimens or when data and biospecimens need to be maintained. 
  

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NOTE: 
In general, participants should be given the choice about whether or not they wish to have their 
data and biospecimens stored and shared for future use. Providing options for participants to 
agree to data and biospecimen storage and sharing is particularly important in studies that offer 
the prospect of direct benefit to the participant. Requiring storage and sharing may be 
considered undue influence if the participant does not want to agree to sharing of data and 
biospecimens but feels compelled to agree anyway to join a possibly beneficial research study. 
  
If the primary research study offers no prospect of direct benefit, it may be reasonable to 
consider requiring storage and sharing in the primary protocol (e.g., if the primary protocol is a 
repository protocol with the sole purpose being to collect data and/or biospecimens for future 
use). In this case, there is no reason to participate if the participant does not want to provide 
consent for storage and sharing. 
 NIH Funded Research: Upload a copy of the Data Management and Sharing Plan 
  
Response: 
  
13.0 Withdrawal of Subjects 
☐    
N/A: This study is not enrolling subjects.  This section does not apply. 
  
13.1 
Describe anticipated circumstances under which subjects may be withdrawn from the 
research without their consent. 
Response: if the participant is unable to participate in the study during the study session for any 
reason, including inability to walk, they would be withdrawn from the study. 
  
13.2 
Describe any procedures for orderly termination.  
NOTE: Examples may include return of study drug, exit interview with clinician.  Include whether 
additional follow up is recommended for safety reasons for physical or emotional health. 
Response: n/a 

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13.3 
Describe procedures that will be followed when subjects withdraw from the research, 
including retention of already collected data, and partial withdrawal from procedures with 
continued data collection, as applicable. 
Response: If a subject withdraws on the day of the study before information is deidentified, their 
data will be removed.  This includes removal of data/videos from the Onform app if they had 
opted in to participate.  
  
13.4 
Describe what will happen to data already collected. 
Response: Data can only be discarded at the time of the study session if the participant 
requests.  After that, we would not be able discard it as there is no matching between the 
person who signed the consent and the random participant/subject ID. As we are not keeping 
any picture of the participants and faces will be obscured on the Onform video recording, after 
the session, we would not be able to delete the videos.   
14.0 Risks to Subjects 
14.1 
Describe if any subjects will be withdrawn from therapeutic procedures or drugs (e.g., 
washout periods) prior to, or during, their participation in the study.  
Response: n/a 
  
14.2 
List the reasonably foreseeable risks, discomforts, to the subjects related to their 
participation in the research. Consider physical, psychological, social, legal, and economic risks.  
NOTE: Breach of confidentiality is always a risk for identifiable subject data. 
• 
Response: Mild skin irritation from wearing the device. 
• 
Temporary muscle fatigue from mobility exercises. 
• 
Dizziness or imbalance while adjusting to the device. 
• 
Minimal risk of falling and sustaining any injury from the fall, with or without device.  The 
study will be conducted in a monitored setting with a healthcare provider who is also a 
part of the research staff available. 
• 
Loss of confidentiality 

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• 
Since this is a research study, not all risks may be known at this time; there may be 
unforeseen risks associated with study participation. 
  
14.3 
Describe the probability, magnitude, duration, and reversibility of the risks and the 
procedures to minimize these risks. 
Response: Participants will be asked to stay in the fixed area at Jefferson’s Ferry, e.g. wellness 
center/gym, for the approximate 1.5 - 2-hour duration of the study. 
  
14.4 
Describe procedures being performed to monitor subjects for safety. 
Response: Participants will be asked to stay in the fixed area at Jefferson’s Ferry, e.g. wellness 
center/gym, for the approximate 1.5 - 2-hour duration of the study. 
  
14.5 
If the study poses risks to an embryo or fetus should the subject be or become pregnant, 
how will you minimize the risk of a pregnancy occurring during the course of the study? (Select 
all that apply.) 
☐    
Counseling on birth control and /or abstinence 
☐    
Pregnancy test during the study 
☐    
Pregnancy test prior to initiation of the study 
☐    
Other   _____ 
  
14.6 
If applicable, describe possible risks to others who are not subjects (e.g., partner of a 
subject who is administered a study drug). 
Response: n/a 
  
14.7 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
☐    
N/A: This study is not enrolling subjects OR is limited to records review procedures only 
OR is a minimal risk study. See SBU SOPs section 3.6 for a list of the procedures that are 

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generally considered to be minimal risk: https://www.stonybrook.edu/research-
compliance/Human-Subjects/sops). 
Response: This study will be performed in a fixed location at Jefferson’s Ferry, e.g. wellness 
center/gym.  Participants will remain at this location for the duration of the study and hence will 
be in a controlled setting for monitoring. 
  
14.8 
Provide information about the Data and Safety Monitoring Plan. 
Response: This is a pilot study on an FDA exempt class I device that is available over the 
counter.  We will actively monitor and record any falls or other device-related adverse events 
occurring during study participation. Although the study poses minimal risk, we recognize the 
importance of safety monitoring. An independent monitor, Dr. Rachel Wong, not part of the 
research team, will be designated to oversee the safety data, specifically the fall incidence. This 
individual will receive fall data at regular intervals (e.g. each time 5 participants have completed 
the study – so they would receive data a total of 4 times, as this would indicate all 20 
participants have completed the study) and will recommend pausing or terminating the study if 
an excessive fall rate is observed or if participant safety is otherwise compromised. 
  
14.9 
Provide information if a medical monitor will be used to monitor the safety of the study. 
Response: no 
  
14.10 Provide information if a Data and Safety Monitoring Committee/Board will be used to 
monitor the safety of a study that is greater than minimal risk. Provide justification if a Data and 
Safety Monitoring Committee/Board will not be used. 
☒   N/A:  
Response: 
  
14.11 Describe what data are reviewed, including safety data, and efficacy data. 
Response: 
  

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14.12 Describe how the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls with participants). 
Response: 
  
14.13 Describe the frequency of safety data collection, including when safety data collection 
starts. 
Response: 
  
14.14 Describe who will review the safety data. 
Response: 
  
15.0 Potential Benefits to Subjects 
15.1 
Describe the potential benefits that individual subjects may experience by taking part in 
the research.   
Response: There is no direct benefit. They may find that their mobility transiently improves with 
the device. 
  
15.2 
Indicate if there is no direct benefit.  
NOTE: Compensation cannot be stated as a benefit. 
Response: There is no direct benefit. They may find that their mobility transiently improves while 
wearing the Accelera device. 
  
15.3 
Indicate if there is a potential benefit to others, future science, or society.   
Response: If the study demonstrates improved mobility and/or confidence with the ankle 
bracelet device then this would be an important finding in geriatric mobility/fall prevention 
literature.  Conversely, if the device fails to improve mobility as assessed above, then that would 
also be important. 

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16.0 Economic Burden to Subjects 
☐    
N/A: This study is not enrolling subjects or is limited to records review procedures only.  
  
16.1 
Describe any costs that subjects may be responsible for because of participation in the 
research.  
NOTE:  Some examples include transportation or parking, insurance co-payments, study drugs. 
Response: none 
  
17.0 Compensation for Participation 
☒    
N/A: There is no compensation for participation.  This section does not apply. 
  
17.1 
Describe the amount/nature and timing/scheduling of any compensation to subjects, 
including monetary, course credit, or gift card compensation. Describe any prorated payments 
based on participation. Add IRS tax information to the consent form per template. 
Response: 
NOTE: If using West Campus Departmental pools, participation in studies may be offered for 
credit in class but students MUST be given other options for fulfilling the research component 
that are comparable in terms of time, effort, and education benefit.  Please indicate the 
alternative activity/related contact information in the consent form. 
  
18.0 Informed Consent 
18.1    Will you be obtaining consent from subjects?  
☒    
Yes (If yes, provide responses to each question in this section, and upload your consent 
documents where indicated in the electronic submission system.) 
☐    
No (If no, skip to the next section.) 

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18.2 
Describe how the capacity to consent will be assessed for all subjects. Review SBU 
SOPs section 5.5 for guidance: https://www.stonybrook.edu/research-compliance/Human-
Subjects/sops). 
Response: These are volunteers in an independent community living setting who are able to 
provide informed consent.  We are only allowing patients who are in the Independent Living 
section of Jefferson’s Ferry and who can consent for themselves to participate in the study. 
While formal capacity testing is not planned, we will implement a two-step assessment to 
ensure each participant has the capacity to consent. First, participants must be oriented to 
person, place, and time. Second, participants must be able to demonstrate understanding of the 
study by accurately restating (using the “teach-back” method) key elements of the consent form, 
including the study’s purpose, procedures, potential risks, and voluntary nature. Should a 
participant be unable to meet these criteria, they will not be enrolled in the study. 
  
18.3 
Describe the consent process that will be conducted to ensure that the subject is fully 
informed regarding study details and subject rights. Include where the consent process will take 
place, with consideration of the need to protect the subject’s right to privacy. 
Response: During the recruitment and screening process, participants' privacy will be protected 
by ensuring that all recruitment activities occur in a confidential manner. Interested individuals 
will contact the study staff directly to express interest. Personal discussions regarding the study 
will take place in private settings, either over the phone or in person, to ensure privacy. Only 
authorized research staff will be involved in the recruitment and screening process. 
In addition, all participant information collected during the screening process will be de-identified 
and stored securely. The research team will use a unique identifier for each participant, and all 
identifiable information (e.g. consents) will be kept in locked cabinets, until they are uploaded 
into a secured Stony Brook Medicine shared drive accessible only to designated research 
personnel. Furthermore, electronic information will be stored on password-protected, encrypted 
servers to prevent unauthorized access. 
 
  
18.4 
Describe how you will ensure that subjects are provided with sufficient time to consider 
taking part in the research study.  Detail if there is any time period expected between informing 
the prospective subject and obtaining the consent.  
NOTE: It is required that the prospective subject receive sufficient time to have their questions 
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Response: The study has been approved by Jefferson’s Ferry leadership.  Prior to initiation of 
the study, there will be an ‘open house’ type forum(s) at Jefferson’s Ferry, where we will discuss 
the study.  As this is purely voluntary, only interested participants are expected to enroll. 
  
18.5 
Describe the process to ensure the subject’s ongoing willingness to continue 
participation for the duration of the research study.  
Response: There is only a single study session in the study.  The participant may withdraw at 
any time during the single study session. 
  
Non-English Speaking Subjects 
☒ 
N/A:  This study will not enroll Non-English speaking subjects.  
 
18.6 
Indicate which language(s) other than English are likely to be spoken/understood by 
your prospective study population or their legally authorized representatives. 
Response:  
18.7 
If subjects who do not speak English will be enrolled, describe the process to consent 
the subjects, as well as the process to be used to ensure their understanding of research 
procedures throughout the conduct of the study. Review SOPs section 17.8 for important 
policies in this regard: https://www.stonybrook.edu/research-compliance/Human-Subjects/sops). 
Response:  
  
Adults Unable to Consent 
☒ 
N/A: This study will not enroll adults unable to consent. 
 
 
18.8 
Justify why it is necessary to include adult subjects who are unable to consent. 
Response: 
  

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18.9 
Describe how you will identify Legally Authorized Representatives (LAR) for the subjects 
that will be consistent with the NYS Family Health Care Decisions Act (FHCDA; see SBU SOPs 
section 5.2 at https://www.stonybrook.edu/research-compliance/Human-Subjects/sops). 
Response: n/a 
  
18.10 For research conducted outside of New York State, provide information that describes 
which individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the research.  
Response: n/a 
  
18.11 Describe the process for obtaining assent from the adult subjects 
Indicate whether assent will be obtained from all, some, or none of the subjects.  If some, 
indicate which adults will be required to assent and which will not. 
Response: n/a 
  
18.12 Describe whether assent of the adult subjects will be documented and the process to 
document assent.  
Response: n/a 
  
18.13 Describe how you will obtain consent from a subject to use their data if they later become 
capable of consent.  Include information regarding how competence will be assessed. 
Response: n/a.  This is a single session study. 
  
19.0 Waiver or Alteration of Consent Process 
☒ 
N/A: A waiver or alteration of consent is not being requested. 
Complete this section if: 
·                 Informed consent will not be obtained at all 

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·                 Informed consent will be obtained, but not documented, or 
·                 Informed consent will be obtained, but not all required information will be disclosed (e.g., 
in deception research) 
  
☐    
A waiver is requested. Complete and upload Supplemental Form G. 
  
19.1 
If the research involves a waiver of the consent process for planned emergency 
research, please contact the Office of Research Compliance for guidance regarding assistance 
in complying with federal regulations governing this activity (see: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/exception-informed-consent-requirements-
emergency-research 
  
20.0 Drugs and Devices 
☐    
N/A:  This study does not involve drugs or devices.  This section does not apply. 
  
20.1 
Does this study involve use of radiopharmaceuticals? 
☐ Yes        
 
☒No 
  
20.2 
For investigational devices, provide the following information below: 
Where will the device(s) be stored? Note that the storage area must be within an area under the 
PI’s control. Describe the security of the storage unit/facility. Provide full details regarding how 
the dispensing of the device(s) will be controlled (accountability of removal/return of used 
devices, and disposition of remaining devices at the conclusion of the investigation) and 
documented (accounting records/logs).   
Response: The Accelera ankle bracelets, FDA class I exempt devices, will be stored at a 
secured location at Jefferson’s Fferry where only research staff conducting the study would 
have access.  Please also see supporting letter from Accelera regarding FDA exemption. 

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20.3 
For investigational drugs (including marketed drugs being used off label), will the 
services of the Investigational Drug Pharmacy be used for storage, dispensing, accounting the 
drug (required for research conducted at UH, HSC, Cancer Center, and Ambulatory Surgery 
Center)? 
☐    
Yes  
☐    
No → Provide the following information below: 
·                 Where will the drugs/biologics be stored? Note that the storage area must be within an 
area under the PI’s control    
·                 Describe the security of the storage unit/facility:      
·                 Provide full detail regarding dispensing of the drugs(s), how labeled, controlled 
(accountability, disposition of unused drug at the conclusion of the investigation) and 
documented (accounting records/logs):    
 
Response: 
  
21.0 Sharing Results with Subjects  
21.1 
Describe whether results (study results or individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings) will be shared with subjects 
or others (e.g., the subject’s primary care physicians) and if so, describe how it will be shared. 
Response: If the volunteers desire, they will be shown the results of their performance on the 
timed up and go, chair stand, and 4-point balance test and app-based gait/posture/mobility 
analysis, before and while wearing the ankle bracelets. 
22.0   Collaboration 
    
☒N/A: This study does not include any collaborations. 
22.1    Internal Collaboration 
Response: n/a 
  

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22.2 
External Collaboration 
Response: Accelera is lending the devices to us for the study and will receive aggregate data.  
22.3    Community Based Participatory Research (CBPR) 
Does this project include community based participatory research?  (Also referred to as 
community-based research (CBR), CBPR is a partnership-based approach to research that 
takes place in community settings and involves community members in the project’s design and 
implementation and dissemination of results.) 
☐    
N/A: This study does not include CBPR.   
 
Response: Yes, we are collaborating with Jefferson’s Ferry.