Active Powered Prosthesis (APEX) for Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: AbiliTech Medical Inc.

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Active Powered Prosthosis (APEX) for Spinal Cord Injury 
Protocol #6100003-100 Rev A 
Study Sponsor: AbiliTech Medical Inc. & The National Institutes of Health (R43HD094440) 
Principal Investigator: 
Jennifer L. Theis, MS, OT/L 
Program Coordinator for Spinal Cord Injury Program and Research 
Clinician, Courage Kenny Rehabilitation Institute 
Clinical Supervisor: 
James B. Spendley, DO 
Medical Director, Spinal Cord Injury Rehabilitation, Courage Kenny 
Rehabilitation Institute 
Co-Investigator: 
Matthew W. White, OTR/L 
Occupational Therapist, Instructor Scientist, Assistive Technology 
Supervisor  
Engineering Director: 
Steven Seme, MS  
VP R&D, AbiliTech Medical 
Abilitech Clinical Director: 
  Shawna Persaud, Ph.D. 
Clinical and Product Manager, AbiliTech Medical 
Design Req Specialist:  
  Angie Conley, BS 
CEO and President, AbiliTech Medical 
Technical Specialist: 
Eli Krumholz, Ph.D.  
Lead Software Engineer, AbiliTech Medical 
Research Project Manager: 
Rob Wudlick, BS 
Project Manager, AbiliTech Medical 
Courage Kenny Rehabilitation Institute 
Allina Health  
800 East 28th Street 
Minneapolis, MN 55407 

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Protocol Synopsis 
Introduction  
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept 
shoulder-elbow-wrist prosthesis device intended to provide non-invasive active powered robotic 
assistive movement to the upper extremities. In September 2017, the National Institutes of Health 
approved and funded the development of the APEX device through a Phase I SBIR Grant. 
(1R43HD094440-01). The APEX device is designed for users with upper level cervical spinal cord injuries 
and motor impairment of their upper extremities. AbiliTech Medical has a history of developing upper 
extremity prosthesis devices. The AbiliTech Assist device is an upper limb passive powered lift and assist 
device planned for release in Q3 2018. The APEX device represents an advancement from the AbiliTech 
Assist device by providing active power sources to lift and rotate the upper limbs. The increased range of 
motion provided by the APEX device will expand the activities of daily living (ADL’s) for users of the APEX 
device.  
Study Objectives 
Objectives:  
Perform focus groups with subjects and clinicians to evaluate a proof of concept active powered 
prosthosis.   
1.
Perform a focus group with three to six individuals with chronic tetraplegia to evaluate the user
control interface of an active powered prosthesis device proof-of-concept prototype. Subjects
will provide feedback on the device function and usability after manipulating the device on a
mannequin.
2.
Perform a focus group with Courage Kenny Research Institute Clinicians to validate device safety
features, performance and assess the potential clinical utility of the device.
Primary Outcomes:  
The following will be assessed: 
1.
User ability to control APEX device to manipulate objects in space
2.
User ability to control APEX to move an object in a preferred pathway
3.
User ability to control APEX device to push buttons
4.
User ability to control APEX to lift a phone
5.
Evaluate subject reported outcomes within their interaction with the APEX device through
interviews and a survey
Secondary Outcomes: 
1.
To observe and assess any uncontrolled device guided movement during the APEX device testing
on mannequin
2.
Gain clinician feedback on device safety control mechanisms
Ancillary Data: 
1.
Subject Acclimatization/ Learning Time to Operate the APEX Device
2.
Characterization of focus group population:
a.
Medical History: Diagnosis, level of injury, AIS classification; MMT Scores (shoulder, elbow,
forearm, hand)
3.
Feedback on device design
4.
Feedback on user input control system

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Study Design/Subject population 
The study design will be that of a single arm pilot testing study with three to six study subjects (n=3-6). 
Target user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA 
Impairment Scale (AIS) A, B, or C. Inclusion and exclusion criteria are summarized below: 
3.1 Inclusion Criteria: 
1.
Spinal cord injury at levels C3 to C5, and AIS A, B, or C
2.
Greater than 3-months post injury or surgery to spinal column, arms, or shoulder
3.
Ability to provide informed consent
4.
Age 18 or over
5.
Selected for participation based on investigator discretion
3.2 Exclusion Criteria: 
1.
Unable to follow instructions
2.
Exhibit significant behavioral problems or impaired cognitive ability
3.
Inability to provide consent
4.
Non-English speaker
Clinicians involved in overseeing the device manipulation portion of the study will be expected to 
provide feedback about the APEX device.  
Recruitment Process: 
After IRB approval, subjects with upper extremity spinal cord injuries will be recruited through: 
1.
An internal search of subject records within Courage Kenny Rehabilitation Institution performed
by an out-patient care coordinator.
2.
This pilot study will be posted and listed on www.clinicaltrials.gov with contact information
available for possible enrollment in the study. Due to the size (n=3-6) of this study and
recruitment methods, issues with recruitment of subjects is not anticipated.
In-Clinic Evaluation  
There are two components to this study: 
1.
Visit 1: User Focus Group:
a.
Consent/Subject Evaluation
b.
Study participant Body Measurements
c.
Device Testing
d.
Focus Group Discussion and Feedback
2.
Visit 2: Clinical Focus Group:
a.
Presentation of Results
b.
Clinical Discussion
The duration of time between visits 1 and 2 is expected to be 2-4 weeks. User focus group participants 
will receive a $50 Visa gift card after completion of all study activities. 
Evaluation of Outcomes 
Primary and secondary outcome measurements will be recorded during the study to assess and validate 
the device feasibility for function and safety. Data will be collected and reported without statistical 
analysis. This study is designed to assess early feasibility and prepare for a larger clinical study in the 

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future. Primary functional and safety outcomes will be compiled and reviewed to assess the 
performance of the APEX device in meeting the requirements of SCI subjects. Pilot Study results and 
conclusions on performance will be provided by AbiliTech Medical and Allina investigators.  
Table of Contents 
1. Introduction ...................................................................................................................... 6 
2. Objectives ......................................................................................................................... 9 
3. Trial Population ................................................................................................................. 9 
4. Study Design .................................................................................................................... 10 
5. Evaluations ...................................................................................................................... 12 
6. Outcomes ........................................................................................................................ 13 
7. Criteria for Study Discontinuation .................................................................................... 13 
8. Statistical Considerations ................................................................................................. 13 
9. Retention of Records ....................................................................................................... 13 
10. Amendments to the Protocol ......................................................................................... 14 
11. Deviations from Investigative Plan ................................................................................. 14 
12. Informed Consent Process.............................................................................................. 14 
14. Risk to Participants ........................................................................................................ 15 
15. References ..................................................................................................................... 15 
Appendix 1: Medical History Report Form ............................................................................ 18 
Appendix 2: Pilot Usability Testing Form .............................................................................. 18 
Appendix 3: AbiliTech Medical APEX Device Feedback Questions ......................................... 20 
Appendix 4: AbiliTech Medical APEX Device Feedback Questions ......................................... 23 
Appendix 5: AbiliTech Medical APEX Device Clinician Feedback Questions ........................... 36 

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1.Introduction
1.1. Disease Background 
Spinal cord injuries (SCI) cause costly and morbid chronic conditions such as lack of voluntary 
movement, increased chance of pressure sores, problematic spasticity, loss of bowel, bladder, and 
sexual function, and more physical impairments which result in a lower quality of life and lack of 
independence. Approximately 285,000 people in the U.S. have SCI with approximately 17,000 new 
subjects added each year [1]. It is recognized that 54% of SCI’s are cervical injuries resulting in upper 
extremity neuromuscular motor impairment [2]. Through a published survey, 48.7% of quadriplegics 
indicated that regaining arm and hand function would be the preferred treatment to improve quality of 
life [3,4]. 
While there are no treatments that reverse all morbidities of SCI, cellular research, spinal cord 
stimulation, and advanced high-intensity fitness regimens show promise in treating the effects of SCI 
and improving independence and quality of life [5,6,7]. Remarkably, subjects with AIS A or B injuries, 
defined as “complete” motor and sensory loss and “incomplete” with sensory but not motor function, 
respectively, have shown improvement in motor scores after 6 months with structured exercise (20). 
Moreover, advances in independence have been shown in subjects with complete injuries after year-
long rehabilitation programs (22). These, and studies on orthotics and exoskeletons used to improve 
strength and neuromuscular health have focused mainly on the lower extremity (1-4) and restoration of 
lower extremity function on improving independence in activities of daily living (ADLs) in subjects with 
cervical SCI (6).  
Recent advances in upper extremity orthotics with devices such as a mobile arm support, WREX, Armeo 
Robotic Arm Trainer, MyoPro, and the Swedish arm support have led to strengthened upper extremities 
and improved independence in activities of daily living (ADLs) of those with cervical SCI [14,15,16]. They 
are limited by cost, size, comfort, weight, and functionality [14]. Another important limitation is that 
many of these devices focus on in-clinic rehabilitation and limit the frequency of rehab opportunities 
and insurance coverage. Recent studies have shown a significant correlation between high frequency of 
rehab sessions and improved outcomes [7,17,18].  
1.2. AbiliTech Medical APEX Background 
The Active Powered Prosthosis (APEX) is a portable upper extremity prosthesis device that helps users 
with upper extremity motor impairment move their upper extremities through active robotic assistance. 
The device is controlled through body motion activation (i.e.: a body mounted 9 degree of freedom 
accelerometer sensor that is wirelessly connected to the device to interpret the user’s movement into 
upper extremity assisted movement).  The APEX device body chassis is worn by the user and has 
onboard processing, power, motors, sensors, and cables attached to the motors . Cables attached to 
the motors will extend throughout the body chassis to enable actuation of the user’s upper extremities. 
The APEX is designed for optimal subject safety including mechanical, electrical and software stops to 
prevent uncontrolled device movement and injury to subjects. 
Arm movement is activated and controlled by the APEX control system (ACS-III) consisting of body 
mounted movement control inputs and sensors, an on-board processor, sensors, motors, and firmware. 
While the APEX mechanical design is the initial concept model, the ACS III control system represents a 
third-generation control and data collection design. User directed control inputs will be 

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body motion activated, sensors will be placed on the head and/or combination of a head mounted 
joystick and buttons.  
This is a first of its kind proof-of-concept model using a mobile Bowden-Cable robotic system to mobilize 
the upper extremity. A similar published research device called the CAREX [19] has demonstrated proof-
of-concept but is stationary and has limited data on its use. 
AbiliTech Medical has experience in developing similar devices. The AbiliTech Assist and the Hand Grip 
glove, funded by the State of Minnesota Spinal Cord and Traumatic Brain Injury Research Grant 
Program, are devices currently in development by AbiliTech Medical. The AbiliTech Assist is a hybrid 
power device. Motors power (active) the compression or relaxation of multiple arm and shoulder 
springs (passive) to provide lift and assist for users with reduced upper extremity mobility. The AbiliTech 
Hand Grip System, uses motors and cables to help users grasp and hold different objects and is similar in 
cable driven architecture to the APEX device. The APEX device will be a third-generation device 
leveraging the design architecture eg. ACS-III and clinical learning experience.  
1.3. Other Similar Devices 
To date, there are no mobile devices available that provide shoulder-elbow active motion assistance 
to individuals with upper extremity motor impairment. There are similar devices, such as the Hocoma 
Armeo® Power which assists with shoulder elbow and wrist movement and diagnosis and the MyoPro, 
which is mobile but only provides elbow and griping assistance. 
1.4. Study Rationale 
Currently there are no effective mobile devices that enable people with limited upper extremity 
movement to move their upper extremities, especially for individuals with upper level SCI (C1-5). This 

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severely limits independence, reduces the ability for individuals with this condition to complete ADL’s 
and makes them dependent on caregivers to complete all physical interactions with their environment. 
We hypothesize that the APEX device can safely enable and control shoulder-elbow movement to 
improve ADL performance and independence. Individuals with upper level cervical spinal cord injury 
that have lost functional use of their arms have a high potential to increase their quality of life by using 
this device which justifies observing their interaction with the APEX Focus Group.  
2. Objectives
Objectives:  
Perform focus groups with subjects and clinicians to evaluate a proof of concept active powered 
prosthesis.   
1.
Perform a focus group with three to six individuals with chronic tetraplegia to evaluate the user
control interface of an active powered prosthesis device proof-of-concept prototype. Subjects
will provide feedback on the device function and usability after manipulating the device on a
mannequin.
2.
Perform a focus group with Courage Kenny Research Institute Clinicians to validate device safety
features, performance and assess the potential clinical utility of the device.
Primary Outcomes:  
The following will be assessed: 
1.
User ability to control APEX device to manipulate objects in space
2.
User ability to control APEX to move an object in a preferred pathway
3.
User ability to control APEX device to push buttons
4.
User ability to control APEX to lift a phone
5.
Evaluate subject reported outcomes within their interaction with the APEX device through
interviews and a survey
Secondary Outcomes: 
1.
To observe and assess any uncontrolled device guided movement during the APEX device testing
on mannequin
2.
Gain clinician feedback on device safety control mechanisms
Ancillary Data: 
1.
Subject Acclimatization/ Learning Time to Operate the APEX Device.
2.
Characterization of focus group population
a.
Medical History: Diagnosis, level of injury, AIS classification
b.
Subject examination: MMT scores
3.
Feedback on device design
4.
Feedback on user input control system
3. Trial Population
Target user population will be three to six individuals with spinal cord injury at levels C3 to C5, and AIS A,
B, or C. Inclusion and exclusion criteria are below:

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3.1 Inclusion Criteria: 
1.
Spinal cord injury at levels C3 to C5, and AIS A, B, or C
2.
Greater than 3-months post injury or surgery to spinal column, arms, or shoulder
3.
Ability to provide informed consent
4.
Age 18 or over
5.
Selected for participation based on investigator discretion
3.2 Exclusion Criteria: 
1.
Unable to follow instructions
2.
Exhibit significant behavioral problems or impaired cognitive ability
3.
Inability to provide consent
4.
Non-English speaker
Clinicians involved in overseeing the device manipulation portion of the study will be expected to 
provide feedback about the APEX device.  
4. Study Design
Part 1: The study design will be that of a single-arm pilot study with three to six human subjects (n=3-6).
The study will inform the AMI design team of customer and APEX design requirements needed to
develop an APEX device for commercial release. Participants will be expected to attend one 180 minute
session.  AbiliTech Medical personnel will be present for user training, during all device evaluation
sessions and to troubleshoot technical problems. Courage Kenny Rehabilitation Institute (CKRI)
personnel will collect subject medical history from medical records once consent and HIPAA
authorization are obtained. Appendix 1, section 1 includes subject information to be collected. Potential
participants will receive the consent form ahead of time to read and study. At the start of visit 1,
subjects will be consented as a group and sign the HIPPA authorization. During device testing, Appendix
2 and 3 include assessment forms for device testing and questions subjects will be asked. Appendix 4,
includes the device feedback survey which will be completed onsite before conclusion of the study.
Subjects will use their personal internet connected mobile device to access and complete the survey. If
subjects do not have a mobile device, a tablet will be available for subject to use and complete the
survey. Audio recordings will be taken and videos of the mannequin will be recorded during device
movement. Table 1 highlights activities to be performed in the User Focus Group.
Table 1: Visit 1: User Focus Group Activities 
Activity 
Description 
1: Consent (Up to 30 
minutes)  
1.1: Review and Sign 
Informed Consent Form (0-
30 minutes) 
Study participants will review and sign 
consent form in a group setting. They will 
be given time as to review and provide 
consent. Consent forms will be mailed to 
scheduled participants in advance of the 
focus group session. 
2: Device Testing and 
Follow up 
(approximately 90 
minutes) 
2.1: Device Instructions and 
Operational Testing (60 
minutes) 
The clinician and AbiliTech Personnel will 
describe to the user on how to operate the 
device. The study participant will acclimate 
to use of the device. Data will be collected 
on the operation, function, and 
performance of the APEX device. Safety 
risks will be assessed. 

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2.2: Device & Follow Up (10-
15 minutes) 
The study participant will provide feedback 
about their experience with the device. 
3: Device Feedback 
(approximately 30-60 
minutes) 
3.1 Complete Survey 
Subject performs Survey Monkey Survey 
on Device Preferences. Compensation 
provided upon survey completion. 
Part 2 of the study will comprise of a clinician focus group to evaluate data gathered in the user focus 
group, AbiliTech bench testing, and motion capture data of the device function.  Appendix 5 includes 
questions for clinicians to answer. Table 2 highlights the Clinician focus group activities. 
Table 2: Visit 2: Clinician Focus Group Activities 
Activity 
Description 
1: Data Review  
(approximately 60 
minutes) 
1.1: Study Data Presentation 
AbiliTech Medical will present data to CKRI 
clinical team. Data includes User focus 
group results and results device bench 
testing. 
2: Device Feedback 
(approximately 60 
minutes) 
2.1 Discussion on Device 
Clinicians and AbiliTech Medical team 
members will discuss the safety and clinical 
utility of the APEX device. 
4.1 Test Schedule 
Tests reflect common Activities of Daily Living, important safety measures, ancillary data, and subject 
satisfaction and interaction with the APEX Device crucial for successful development of the APEX Device. 
Table 3: Test Schedule 
Outcome 
Measure 
Notes 
Visit 
After 
consent and 
HIPAA 
authorization 
obtained 
1 
2 
Medical 
History 
CKRI research staff will gather pertinent medical 
history of subjects ahead of clinical visit. 
X 
Mannequin 
Test #1: 
Object 
Movement 
Can the subject manipulate the device on a 
mannequin to manipulate an object in space? 
(Assistive Grip Device Allowed for use)? (Yes/No) 
Assisted 
Mannequin 
Test #2: 
Object 
Movement 
Can the subject manipulate the device on a 
mannequin to manipulate an object in a preferred 
pathway (Assistive Grip Device Allowed for use)? 
(Yes/No) 
Assisted 

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with 
Intention 
Mannequin 
Test #3: 
Button Push 
Can the subject manipulate the device on a 
mannequin to push an elevator button? (Yes/No) 
Assisted 
Mannequin 
Test #4: Lift 
Cell Phone 
Can the subject manipulate the device on a 
mannequin to lift a cell phone? (Yes/No) 
Assisted 
Safety: 
Observational 
Data on 
uncontrolled 
device guided 
movement  
Observe if uncontrolled device movement occurs 
(Yes/No) 
X 
Time using 
Device 
Record time subject spends using device 
X 
Open Ended 
Feedback 
Data recorded from study participants from set 
questions. (See Appendix 2) 
X 
Data Review 
X 
Clinician 
Feedback 
X 
4.2 Recruitment Plan 
After IRB approval, subjects with upper extremity spinal cord injuries will be recruited through: 1) an 
internal search, match, and communication of subject records within Courage Kenny Rehabilitation 
Institution performed by an out-patient care coordinator and/or PI, 2) this trial will be posted and listed 
on www.clinicaltrials.gov with contact information available for possible enrollment of this study. Due to 
the size (n=3-6) of this study and recruitment methods, issues with recruitment of subjects is not 
anticipated. A list will be compiled and pre-screened by the principal investigator. 
Potential study participants will be contacted by a research clinician to determine their interest in 
participating in the APEX pilot study. Consent forms will be sent out in advance of focus group session. 
The consent form will be reviewed with the potential study participants in a group setting.  
5. Evaluations
5.1 Pre-study Evaluations 
As part of the Screening, potential subject medical records will be evaluated by a clinician at 
Courage Kenny Rehabilitation Institute to match inclusion or exclusion criteria. No data will be 
collected or recorded until an informed consent form is reviewed and signed by the study 
participant. Patients who have indicated that they are not willing to provide access to their medical 
records for screening purposes (MRA ‘No’) will not be screened for study participation.   
5.2 Evaluation During Study 
During the visits, subjects will be assessed and supervised by the PI and/or the co-collaborators. 
Subjective and Objective tests and data will be collected for data analysis. 

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5.3 Post-Study Evaluations 
None of the subjects will be followed or have data recorded after the visit, unless an adverse event 
is reported that relates to their participation in this study. 
6. Outcomes
The fundamental purpose of conducting this pilot study is to examine the feasibility and safety of an 
APEX device, and examine the feasibility of an approach to ultimately be used in a larger scale study.  
Upon successful completion of the APEX Pilot Study, AbiliTech plans to submit for a Phase II NIH grant to 
complete product and clinical development on the path to commercial release of the APEX device. 
The APEX Pilot Study includes assessments and other metrics that measure function and gather 
feedback as listed in Table 3.  
Concept model device feasibility will be subjectively evaluated and defined as follows:  
1.
Manipulation of Mannequin: Were the users able to control the device with intention?
2.
Usability Outcomes: User feedback on device performance, user input controls and overall
comfort.
3.
Clinician Feedback: Are there features that should be integrated into the device to enhance
clinical utility?
Principal Investigator and Clinician feedback on overall device performance will be factored into the 
concept model feasibility results. 
7. Criteria for Study Discontinuation
AbiliTech Medical will document any study participant subject discontinued from the APEX pilot study. 
The documentation will contain the rationale for study participant subject to be discontinued from the 
study. The PI must be notified immediately if a study participant subject discontinues the pilot study. 
Any data from the discontinued study participant subject will be maintained and may be used in the 
data analysis.  
A study participant subject in this study may be discontinued for any of the following reasons: 
x 
At the Investigator’s discretion; 
x 
At the subject’s discretion; 
x 
If the subject has a severe injury or illness within or outside of the study that affects their 
participation in the study; 
8. Statistical Considerations
Data will be recorded and reported. No statistical analysis will be performed since the subject 
population is n=3-6. This study is designed to assess early feasibility and prepare for a larger clinical 
study in the future.  
9. Retention of Records

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In compliance with the ICH/GCP guidelines the investigator will maintain all CRFs and all source 
documents that support the data collected from each subject, and all trial documents as specified in 
Essential Documents for the Conduct of a Clinical Trial and as specified by the applicable regulatory 
requirement(s). The investigator will take measures to prevent accidental or premature destruction of 
these documents. Essential documents will be retained until at least two years after the last approval of 
a marketing application in an ICH region or at least two years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents will be retained 
for a longer period if required by the applicable regulatory requirements or by an agreement with the 
sponsor. These documents will be retained for a longer period if required by Abbott Northwestern 
Hospital policies and procedures.  
Original documents will be secured in a locked cabinet in the Courage Kenny Research Center.  Copies 
that do not identify the study participant human subjects (using a code such as AMI-CKRI-XXX) may be 
shared with AbiliTech Medical for data and evaluation. AbiliTech will store the data in a locked cabinet 
on company premises with restricted access. Electronic copies with de-personalized data may be 
analyzed in an excel file. De-identified survey results will be collected and stored in Survey monkey web 
application for data analysis. Audio recordings will be transcribed and de-identified. Video recordings 
will be of device function and not of focus group participants.  
10. Amendments to the Protocol
All protocol amendments will be submitted to the IRB. Amended protocol will be reviewed, approved 
and documented by the same method as the original protocol was reviewed and approved. 
Once the amended protocol and all associated documents are reviewed and approved, the most recent 
protocol version and effective date will be changed on all pages of the protocol. Study personnel will 
notified of any protocol deviations. 
11. Deviations from Investigative Plan
The Investigator is not allowed to deviate from the clinical investigation plan. Under emergency 
circumstances, deviations from the protocol to protect the rights, safety and well-being of human 
subjects may proceed without prior IRB. Such deviations shall be documented and reported to the IRB as 
soon as possible. 
Deviations are will be reported in a site-specific deviation/violation log. Serious protocol violations will 
be reported in writing, with the corresponding log to the IRB within 24 hours.  
12. Informed Consent Process
Potential study participants will be contacted by a research clinician to determine their interest in 
participating in the APEX pilot study. Consent forms will be sent out in advance of focus group session. 
The consent form will be reviewed with the potential study participants in a group setting.  
The investigator and Research Staff will be responsible to assure that informed consent has been 
provided by a subject before study participation. 

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14 
Prior to carrying out any protocol-specific procedures, investigators or designated staff will fully explain 
the details of the protocol, study procedures, and the aspects of subject privacy concerning research 
specific information. The original signed documents will become part of the subject’s medical record, 
and each subject will receive a copy of the signed documents. All subjects must provide written 
informed consent prior to registration and treatment.  
The following points will be observed during the informed consent process: 
a)
The principal investigator or her authorized designee conducts the informed consent process
b)
All aspects of the clinical investigation that are relevant to the subject's decision to participate
will be included
c)
Any coercion or undue improper influence on, or inducement of, the subject to participate will
be avoided
d)
Ample time for the subject to read and understand the informed consent form and to consider
participation in the clinical investigation will be used
e)
Personally dated signatures of the subject and the principal investigator or an authorized
designee responsible for conducting the informed consent process will be included in the
informed consent form
f)
The subject will be provided with a copy of the signed and dated informed consent form and any
other written information
g)
Important new information will be provided to new and existing subjects throughout the clinical
investigation
Subjects that are unable to provide consent on their own will not be included in this study. 
13. Reporting Requirements
The reporting plan for this study to relevant regulatory agencies will be as follows: 
Progress Reports or Annual Reports 
x 
Will be submitted at least once a year to reviewing IRB. 
Study Completion or Termination 
x 
Investigator will notify the reviewing IRB of the completion or termination of the study within 30 
working days of termination and submit a final report within 6 months after completion or 
termination.  
14. Risk to Participants
Participation in this trial is considered low risk. Subjects will only manipulate the device on a mannequin 
using a head worn accelerometer. The risks to the subjects are the normal risks that can occur with 
when using a remote control. To protect against physical risk, subjects will be closely monitored by CKRI 
clinical staff and AbiliTech Medical personnel during the entire time they are controlling the prosthesis.  
15. References

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1. National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance.
Birmingham, AL: University of Alabama at Birmingham, 2016,
https://www.nscisc.uab.edu/Public/Facts%202016.pdf .
2. National Spinal Cord Injury Statistical Center, University of Alabama at Birmingham,
2015 Annual Statistical Report – Complete Public Version https://www.nscisc.uab.edu/ .
3. Anderson, Kim D., “Targeting Recovery: Priorities of the Spinal Cord-Injured Population”,
JOURNAL OF NEUROTRAUMA, Volume 21, Number 10, 2004, Pp. 1371-1383.
4. Snoek, G. J., IJzerman M. J., Hermens, H. J., Maxwell, D., Biering-Sorensen, F.,
“Survey of the needs of subjects with spinal cord injury: Impact and priority for
improvement of hand function in tetraplegics.”, Spinal Cord. (2004):42, 526-532.
5. “Spinal Cord Injury: Hope Through Research”, NINDS, NIH Publication No. 13-160, July
2013, https://www.ninds.nih.gov/Disorders/Subject-Caregiver-Education/Hope-Through-
Research/Spinal-Cord-Injury-Hope-Through-Research
6. Harness ET, Yozbatiran N, Cramer SC, “Effects of intense exercise in chronic spinal
cord injury.”, Spinal Cord, 2008 .Nov; 46(11):733-7.
7. Dunn JA, Sinnott KA, Rothwell AG, Mohammed KD, Simcock JW, “Tendon Transfer
Surgery for People With Tetraplegia: An Overview.”, Arch Phys Med Rehabil, 2016
Jun;97(6 Suppl):S75-80.
8. Fox IK, Davidge KM, Novak CB, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE.,
“Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury:
Update and Preliminary Outcomes.”, Plast Reconstr Surg., 2015 Oct; 136(4):780-92.
9. Patil S, Raza WA, Jamil F, Caley R, O’Connor RJ., “Functional electrical stimulation for
the upper limb in tetraplegic spinal cord injury: a systematic review.”, J Med Eng
Technol. 2014;39(7):419-23.
10. Bickel CS, Yarar-Fisher C, Mahoney ET, McCully KK., “Neuromuscular Electrical
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11. Beekhuizen, K. S. & Field-Fote, E. C., “Massed practice versus massed practice with
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incomplete cervical spinal cord injury.”, Neurorehabilitation and Neural Repair,
(2005);19, 33-15.
12. Atkins MS, Baumgarten JM, Yasuda YL, Adkins R, Waters RL, Leung P, Requejo P.,
“Mobile arm supports: evidence-based benefits and criteria for use.”, J Spinal Cord Med.
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of motion requirements for upper-limb activities of daily living.”, American Journal of
Occupational Therapy, (2016) 70, 7001350010. http://dx.doi.org/
10.5014/ajot.2016.015487

                 
  
                     
                  
               
                                                                    
                                                                              
                                                                      
                                   
              
           
    
                        
                              
                      
                                            
                                                                    
                              
      
                    
                  
              
                                  
                                     
                                                         
      
                            
                          
          
   
                            
                          
          
                   

                 
  
                                                      
      
                      
      
                                                  
     
                 
  
 
                         
  
  
                            
  
  
                                                                 
 
   
                             
  
  
    
                   
  
  
                  
  
  
                                                 
                               
  
  
                                   
  
                      
  
  
                       
  
  
              
  
  
                          
  
                    
                 
  
   

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Utility 
1. On a scale of 1 to 5, how would the APEX System improve your ability to use your arms? (1
no improvement - 5 strong improvement)
2. In general, what would you like to be able to do with your arms?
3. What are three to five Activities of daily living that you wish you could perform, listed in
priority?
4. Do you think using the APEX device you could do [each of the ADL they stated]?
Device Feedback 
1. What is your general impression of the APEX System, knowing the development phase it is
in?
2. Would you use the APEX System? How much? Where? When? For what Uses?
3. What do you like about the APEX System?
4. What do you dislike about the APEX device?

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5. What could be improved about the APEX device?
6. What is your opinion about the size, appearance, texture, color, and/or noise of the APEX
device?
7. What is your opinion on the control system?
8. What type of control system would you prefer?
9. What is your opinion on the user interface?
10. What improvements in the control system or user interface would you like?
11. Would you be interested in predefined pathways of motion to assist in control of the device?
12. What safety concerns do you have about the APEX system?
13. What could be done to minimize these risks?

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Appendix 4: AbiliTech Medical APEX Device Feedback Questions 
AbiliTech Medical APEX Device 
Subject Device Survey Questions 
APEX Survey Monkey Questions 
1. What is your gender?
2. What is your age?
18-29 years old
30-49 years old
50-64 years old
65 years and over
3. How long ago was your injury?
less than 6 months
6 months to 1 year ago
1 - 2 years ago
2 - 5 years ago
5- 10 years ago
10-20 years ago
25+ years ago 
4. How were you injured?
Sports (any type including diving, surfing, ...)
Transporting (car, truck, ATV, motorcycle, bike, ...)
Slip, Trip, or Fall (including falls from height)
Assault (stab, gunshot, ...)
Non-Traumatic Cause (birth, infected, tumor, ...)
Other Traumatic Cause
Unknown
Other (please specify)
5. My injury is defined as:
ASIA A: No Motor & Sensory
ASIA B: No Motor & Some Sensory
ASIA C: Significant Motor & Some Sensory
ASIA D & E: Functional Motor Skills Below Injury
Unsure 
5209 Morgan Ave. S.   Minneapolis, MN 55419 
612-483-6100          www.abilitechmedical.com 

 
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Appendix 5: AbiliTech Medical APEX Device Clinician Feedback Questions 
AbiliTech Medical APEX Device 
Clinician Feedback Questions 
APEX Study Questions 
1.
Are there features that should be integrated into the device to enhance clinical utility?
2.
Do you have any safety concerns for the use of this device?
3.
Do you have feedback on how safety mechanisms can be improved?
4.
How would this device benefit your patients?
5.
What motions or activities of daily living would be most meaningful for your patients?
6.
What type and intensity of training and acclimation would you like to work with your patients
for this device?
7.
Are you interested in monitoring subject compliance with device?
8.
What improvements of the device would you suggest?
5209 Morgan Ave. S.   Minneapolis, MN 55419 
612-483-6100          www.abilitechmedical.com