Development of Vision-Guided Shared Control for Assistive Robotic Manipulators
Phase: NA
Conditions: Spinal Cord Injury/Disorder
Sponsor: VA Office of Research and Development

 
Development of Vision-Guided Shared 
Control for Assistive Robotic Manipulators 
 
 
NCT04323449 
 
 
October 9, 2023 

A completed and signed Research Financial Conflict of Interest Statement is required for all investigators 
(including Principal Investigators, Co-Principal Investigators, and Co-Investigators) listed on the study 
application. Financial Conflict of Interest Form-Nov. 2013 
Description 
Study Identification Information 
This is the first step in your Human Research Application. You will automatically be guided to the appropriate forms 
needed to complete your submissions. 
1.0 
* Study Name: 
Evaluation of Vision-Guided Shared Control for Assistive Robotics Manipulators 
 
2.0 
* Brief Description (using layman's terms) - 500 words or less: 
The purpose of this study is to evaluate a new control (i.e., the vision-guided shared (VGS) control) for a 
wheelchair-mounted assistive robotic manipulator among powered wheelchair users. This study will consist 
of a questionnaire about general demographics, health information, and previous experience with assistive 
technology. Several tests will also be administered to test upper extremity function and ability as well as 
to test spatial orientation and visualization ability. Participants till then undergo a training phase with the 
assistive robotic manipulator mounted on a table to assess if they will be eligible for participation in the 
study. Eligible participants will move on to a second training phase where they will be asked to learn and 
practice slightly more complex tasks while using the vision-guided shared controller. After this training the 
assistive robotic manipulator will be mounted to the participants wheelchair, a table, or a stand and they 
will be asked to complete a number of everyday tasks from a task list. At the conclusion of the study, we 
will conduct a brief semi-structured interview with each participant and obtain more insight on how 
participants perceive the ease-of-use and usefulness of the VGS control. 
 
3.0  
* Is this research study a Greater than Minimal Risk Clinical Trial? 
Yes 
No 
 
4.0  
* Is this study a Greater than Minimal Risk Comparative Effectiveness research? 
Yes 
No 
 
5.0 
* Principal Investigator: 
Dan Ding 
 
5.1 
* VA hours per week the PI is devoted to project: 
15 
 
5.2 
* Is the PI working with ionizing radiation? 
Yes 
No 
 
5.3  
* Is the PI working with biological hazards? 
Yes 
No 
 
5.4 
* Is the PI shipping biological hazards? 
Yes 
No 
 
 
 
5.5 
Upload Financial Conflict of Interest Statement: 
Ding FCOI.pdf(0.02) 
 
6.0 
Research Staff: 
 
7.0 
Type of Submission: 
 
This is a new study. This has not previously been submitted to the IRB. 

ID: Pro00003276 
View: 1.2 VA Involvement 
 
 
This is a new paper conversion. This study has been previously approved by the IRB. 
 
 
If this is a 'New Paper Conversion' please include the MIRB Number: 
 
 
Please upload a letter certifying that you have made no modifications or amendments in converting this 
research study from paper to electronic: 
 
Study Identification Information (Continued) 
1.0 
* Do you certify that all research staff administering informed consent are knowledgeable about 
the study? 
yes 
 
2.0 
* To the best of your knowledge do you, or any member of your research staff, have any 
potential, actual or perceived conflict of interest of a professional or personal nature that may 
affect any aspect of the research, including, but not limited to, the review and/or conduct of this 
study? 
Yes 
No 
 
If yes, provide a description, including name of study team member with conflict: 
 
3.0 
* Qualifications of the Investigators: 
Dan Ding, PhD received her Ph.D. in mechanical and automation engineering from the Chinese University of 
Hong Kong, Hong Kong, in 2001. She is an associate professor in the Department of Rehabilitation Science 
and Technology, University of Pittsburgh. Dr. Ding's research interests include rehabilitation and assistive 
devices, wearable devices for rehabilitation applications, and assistive robotics. Dr. Ding serves or has 
served expert reviewers of several peer-reviewed journals and conferences in the field of rehabilitation 
engineering. She has published over 100 papers in refereed professional journals and international 
conference proceedings. Dr. Ding will serve as the principal investigator of this project. 
Dr. Cooper is a VA Senior Research Career Scientist and Distinguished Professor at Pitt. Dr. Cooper has 
extensive experience in developing and evaluating assist robotic interventions for people with severe 
physical limitations. He will assist with the overall direction of the project and provide guidance the training 
and testing procedures as well as data collection. 
 
Dr. Chung is a research scientist at HERL, and has extensive experience and expertise in developing custom 
user interfaces and share control schemes for assistive robotics. He will be helping training and fitting the 
assistive manipulator to participants and the entire testing procedure. He will also assist with the exit 
interview with the participants. 
 
Dr. Styler is a postdoctoral researcher at HERL. She has over 7+ years of industry software experience and 
advanced degrees from CMU in robotics. She will help with training and data collection on the software 
system as well as assisting participants during the testing procedure. 
Lindsey Morris OTD OTR/L, completed her doctorate of Occupational Therapy at the Massachusetts General 
Hospital Institute of Health Professions(MGH IHP) in May of 2020. She has experience and expertise in 
developing and evaluating technology-based interventions for people with disabilities. She will service as a 
co-investigator in this project and assist with cognitive screening, baseline assessment, and subject testing. 
 
VA Involvement 
ID: Pro00003276 
View: 1.0 Study Identification Information 

Name 
ID: Pro00003276 
View: 1.3 Study Funding Information 
ID: Pro00003276 
View: 1.4 Resources 
1.0 
Does the proposed research involve any of the following?: 
 
 
VA Funding 
 
 
VA Personnel Funded Effort 
 
 
VA Patients or their Private Health Information 
 
 
Other VA Resources: Central IRB 
 
 
Other VA Resources: VA Equipment 
 
 
Other VA Resources: VA Property (Including space leased to, or used by VA) 
 
 
Other VA Resources: VA Databases 
None of the Above apply to this research 
 
Study Funding Information 
 
1.0 
* Funding Sources: 
 
View Merit Review (CC 103) 
9003 
 
2.0 
Upload Grant Application, if applicable (If NIH, VA, voluntary agency, must upload): 
 
VA Merit Review Proposal 
10/21/2019 2:29 PM 
 
1.0 
* Do you currently have adequate resources (e.g., staff, physical space, information technology, 
etc.) to protect the safety of participants, staff, and the confidentiality of subjects’ data during 
the conduct of this study? 
Yes 
No 
 
If yes, include a listing of the VAPHS resources that will be used for this study and are necessary to protect 
participants. 
The Human Engineering Research Laboratories (HERL) has over 20,000 square feet of laboratory space 
which includes separate areas focusing on: Biomechanics, Activities of Daily Living, Robotics, Standards 
Testing, and Design and Prototyping. 
 
All necessary resources are readily available and experienced staff members (clinicians, engineers, research 
coordinators) assist the PI in implementing and overseeing the research. Protected servers and restricted 
access file rooms are available for the secure storage of study data. 
 
 
If no, please describe the resources that will be needed and explain how the resources will be obtained 
before the study is initiated: 
Funding Source 
(Other) 
Code 
Name 
Modified Date 

ID: Pro00003276 
View: 1.5 Project Information 
2.0 
* VAPHS requires that either the PI or co-PI have a physical presence at VAPHS. Please describe 
the role the PI and/or co-PI have at VAPHS with respect to clinical responsibilities or in relation 
to other research activities. 
Dr. Ding is a 4/8ths VA employee (VA Biomedical Engineer). Dr.Ding has an office at HERL in Bakery 
Square, where she is majority of her work time. 
 
3.0 
* Will off-site ancillary service facilities (e.g., radiology services, central labs, non VA space, etc) 
be used for this study? 
Yes 
No 
 
If yes, please provide the location and a brief description of the project activities to be conducted at the off- 
site ancillary facilities: 
4.0 
* Will a firm be contracted to obtain consent from subjects, collect private individually 
identifiable information from human subjects, or be involved in activities that would 
institutionally engage the firm in human subjects’ research? 
 
Yes 
No 
If yes, please provide a description of the contracted service(s): 
 
 
* Please specify the IRB that has oversight of the firm's activity(ies): 
 
There are no items to display 
 
5.0 
Collaborations 
Please list any non-VAPHS institutions or individuals (i.e. co-authors, mentors, etc.) that you will collaborate 
with and describe their specific role in the research: 
 
5.1 
If this is not Multi-Site Research, please upload the appropriate written agreement(s) here: 
 
There are no items to display 
 
1.0 
Does the project involve any of the following (check all that apply): 
 
 
Biological Hazards (including human biological specimens) 
 
Chemicals 
 
Ionizing radiation or use of radioactive materials 
 
Drug, Biological, or Nutritional (e.g. herbal or dietary) Supplement 
 
 
2.0 
Project Focus (check if applicable): 
 
 
Traumatic Brain Injury (TBI) 
 
 
Post Traumatic/Post Deployment Stress Disorder (PTSD/PDSD) 
Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) 
 
3.0 
KEYWORDS 
Please provide a minimum of 3, maximum of 6 keywords. Please use MeSH terms. 
Name of Site / Institution 
 IRB Approval Document 
FWA Number 
Name 
Type 
Type 

ID: Pro00003276 
View: 1.6 (CR) Study Locations 
ID: Pro00003276 
View: 1.6.1 (CR) Multi-Site Study 
ID: Pro00003276 
View: 1.7 Section Chief and Service Line VP approvals 
ID: Pro00003276 
View: 2 Study Objectives & Design 
* Assistive robotics 
* Upper limb impairments 
* Power wheelchair users 
Activities of daily living 
 
 
4.0 
* Please describe the type of study: 
Randomized crossover design 
 
 
5.0 
* Will any of the research being conducted as a part of this study be used to fulfill academic 
requirements (e.g., master’s thesis, dissertation, or other academic program requirements 
necessary to obtain a degree/certification, etc.)? 
Yes 
No 
 
Study Locations 
1.0 
* Please add the local sites where this study will be conducted: 
 
View Other 
 
If Other, Please Specify: 
Human Engineering Research Laboratories (Bakery Square Location) 
Participants’ home 
 
1.6.1 Multi-Site Study 
1.0 
* Is this a multi-site study: 
Yes 
No 
 
Please upload the approval of the Section Chief, if applicable and the Service Line VP. 
 
1.0 
* Institutional Approval Document: 
Request to Conduct Research.pdf(0.01) 
 
 
Study Summary 
 
1.0 
Funding End Date: 
3/31/2023 
 
2.0 
* Abstract. Please provide a brief description of the study. 
 
 
The purpose of this study is to evaluate a new control (i.e., the vision-guided shared (VGS) control) for a 
wheelchair-mounted assistive robotic manipulator among powered wheelchair users. This study will consist 
of a questionnaire about general demographics, health information, and previous experience with assistive 
Location 

technology. Several tests will also be administered to test upper extremity function and ability as well as to 
test spatial orientation and visualization ability. Participants till then undergo a training phase with the 
assistive robotic manipulator mounted on a table to assess if they will be eligible for participation in the 
study. Eligible participants will move on to a second training phase where they will be asked to learn and 
practice slightly more complex tasks while using the vision-guided shared controller. After this training the 
assistive robotic manipulator will be mounted to the participants wheelchair, a table, or a stand and they 
will be asked to complete a number of everyday tasks from a task list. At the conclusion of the study, we 
will conduct a brief semi-structured interview with each participant and obtain more insight on how 
participants perceive the ease-of-use and usefulness of the VGS control. 
 
3.0 
* Describe the study objectives. Please include primary aim and hypothesis, if applicable any 
secondary aims and hypotheses. 
Aim: To evaluate the Vision Guided Shared (VGS) control among 21 powered wheelchair users who will use 
a wheelchair-mounted ARM to complete a set of functional manipulation tasks. 
 
Hypothesis 1: Subjects will be more efficient when using the VGS control as opposed to the default control, as 
measured by the number of mode switching, and time taken to complete individual tasks. 
Hypothesis 2: Subjects will be more effective when using the VGS control as opposed to the default control, as 
measured by the number of tasks successfully completed. 
Hypothesis 3: Subjects will report better usability for the VGS control than the default control as measured by 
the NASA Task Load Index (NASA-TLX) and the System Usability Scale (SUS). 
 
4.0 
* Provide a summary of the background of the study, and explain how this research will 
contribute to existing knowledge. Describe previous studies that provides a basis to show that 
the proposed research can be carried out without undue risk to human subjects. 
There has been a good amount of work on developing new ways to control assistive robotic 
manipulators (ARMs) and make them easier to use. However, most work focused on technology 
development and validation, and did not include subject testing with intended users on functional 
tasks. We have done a literature search on ARMs over the past five years, and found 28 articles 
(excluding our own work), where only six of them included users with disabilities in subject testing. 
For example, Pulikottil et al. (2018) developed a voice control approach and tested it with 2 
individuals with disabilities in a laboratory setting on a single task of grasping a bottle, displacing it 
and simulating to pour its content into a glass. Lebrasseur et al. (2018) evaluated three simple control 
algorithms including preset position, filtering, and drinking mode among 14 individuals with 
disabilities in a laboratory setting on five tasks (i.e., reaching to a button that simulates pushing an 
elevator button, reaching above a plate on a table and a position near the mouth that simulates eating, 
grabbing a glass of water on a table, grabbing a pen from a pencil holder, and drinking with a straw). 
Park et al. (2019) developed a meal-assistance control system using a general-purpose mobile 
manipulator (i.e., a Willow Garage PR2) and tested it with 9 individuals with motor impairments in a 
laboratory setting. The system provided a user interface for users to select different tasks and feeding 
locations, and used computer vision and other sensors to enable the robot to autonomously deliver 
food to the user’s mouth. Quintero et al. (2015) developed a vision-based interface and tested it with 
one individual with quadriplegia on two tasks, i.e., an orientation task where the user was asked to 
locate the robot hand in a right, top, and front orientation with respect to the object on a tabletop, and 
a drinking task. Although these four studies included testing with intended users, most had a very 
small sample size and a quite limited set of tasks. Finally, a majority of the work over the past five 
years developed new control interfaces for ARMs such as gaze control, tongue control, BCI (Brain 
Computer Interface) via EEG, body movement control via IMU (Inertial Measurement Unit), and 

ID: Pro00003276 
View: 2.1 Required Reviews 
gesture control via computer vision, however, these new control methods are limited as a proof-of- 
concept and far from being deployable for real-world use by intended users. The goal of this project is 
to combine vision-guided shared (VGS) control with two types of environment modifications to 
address the effectiveness and efficiency of ARMs for real-world use. We will evaluate it with 
functional instead of discrete tasks. 
 
5.0 
* Describe the overall significance of the research in terms of the problem to be studied and 
potential findings, as well as its relevance to the care of veterans, the VAPHS, and the VHA: 
Veterans who use powered mobility devices including those with high-level spinal cord injury 
(SCI), amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS) often experience severe upper 
extremity impairments. In addition, many older Veterans and Veterans with hemiplegia may also suffer 
from a functional loss in their upper extremities. About 1 in 10 adults aged 55 years and over had 
difficulty reaching or grasping, with rates for those aged 85 and over 2.5 times that of adults aged 55- 
64. Approximately half of the individuals with hemiplegia have a non-functional arm and hand even four 
years after a stroke. Upper extremity impairments can lead to functional limitations in many activities of 
daily living (ADLs) such as selfcare, eating/drinking, and meal preparation, resulting in decreased 
independence, participation, and quality of life. In a survey by Anderson et al. with 347 individuals with 
tetraplegia, 48.7% indicated that regaining arm and hand function would most improve their quality of 
life while only 7.8% considered regaining walking as the highest priority. In addition, the priority of 
regaining arm and hand function did not change whether someone was injured 0-3 years or more than 3 
years post-injury. In a survey of 89 wheelchair users and 52 health care professionals, the ability to 
reach adequately for objects was rated as the most important concern. 
 
Management and care of upper extremity impairments often involve a range of assistive solutions 
including implanted functional electrical stimulation (FES) devices, feeding robots, robotic orthoses, 
and assistive robotic manipulators. However, product availability and technological advancement for 
manipulation assistance fall far behind those for mobility. For example, powered wheelchair 
technologies have evolved to not only allow Veterans with severe physical limitations to move from 
point A to point B, but make it easier for them to stay in their wheelchairs for extended periods of time 
by providing advanced seating systems for comfort, stability, and medical benefits, remote monitoring, 
and autonomous navigation. However, many of these individuals, despite their independent mobility, 
cannot reach for a glass of water, make a simple meal, and pick up a toothbrush. They still require 
assistance from a personal caregiver for essential activities of daily living (ADLs) involving reaching 
and object handling/manipulation. Yet, the shortage of personal care attendants, unrelieved caregiver 
strain, financial concerns, and other care-related challenges make it difficult to fulfill the 
rapidly growing needs for caregivers. The inability to perform ADLs independently may also trigger the 
need for relocation to residential care settings, and significantly impact the quality of life and self- 
esteem of these individuals. 
 
We expect to improve manipulation functions of Veterans with upper limb impairments through a more 
practical and usable implementation of vision-based robotic control and human-robot interaction 
technologies. The mission of the VA Prosthetic & Sensory Aids Service (PSAS) is to provide 
comprehensive support to optimize the health and independence of the Veteran. The proposed work 
clearly supports this mission by maximizing the potential of ARMs in assisting Veterans with everyday 
manipulation tasks and supporting the adoption of this advanced assistive technology. The use of 
enhanced ARMs in home and community could potentially lead to improved independence and the 
ability of Veterans with upper limb impairments to integrate into the community, as well as reduced 
attendant care need and cost. 
 
6.0 
Please upload any additional documents: 
 
There are no items to display 
 
Required Reviews 
Name 
 Version 

Name 
1.0 
Type of Submission: 
New study 
If this is a 'New Paper Conversion' please include the MIRB Number: 
 
 
Please upload a letter certifying that you have made no modifications or amendments in converting this 
research study from paper to electronic: 
2.0 
* Requested Review Type: 
 
Exempt 
 
 
Expedited 
 
Full IRB Review 
 
Not Human Subject Research 
 
 
3.0 
Please check which of the following Service Lines/Departments/Entities 
will be impacted or used in the conduct of this study 
Upload Letter 
of Support 
 
Clinical Support 
 
Medical Specialty 
 
Investigational Drug Service 
 
Imaging 
 
Community Based Care 
 
Patient Care Services 
 
Behavioral Health 
 
Primary Care 
 
Surgical Specialty 
 
Critical Care 
 
Clinical Trials Center 
Regulatory Coordinator Support Core 
Clinical Coordinator 
Support Core 
Ancillary Support Core 

ID: Pro00003276 
View: 2.1.1 Expedited Qualification 
 
Data Support Core 
 
Research Registry 
Registry Number: 
 
Other 
 
If Other, please specify: 
 
 
REQUEST FOR EXPEDITED REVIEW 
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests. 
 
AND 
Identification of the subjects and/or their responses would not reasonably place them at risk 
of criminal or civil liability or be damaging to the subject’s financial standing, employability, 
insurability, reputation, or be stigmatizing, or reasonable and appropriate protections will be 
implemented so that risks related to invasion of privacy and breach of confidentiality are 
minimal. 
 
1.0 
* Please certify that ALL of the following are true: 
 
Research presents no more than MINIMAL RISK to subjects (considering physical, psychological, social, 
legal and economic risk) 
 
Identification of the subjects and/or their responses WOULD NOT reasonably place them at risk of criminal 
or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or 
be stigmatizing, OR reasonable and appropriate protections will be implemented so that risks related to 
invasion of privacy and breach of confidentiality are minimal. 
The research is not classified. 
 
The research involves only procedures listed in one or more of the categories listed in Section 2. 
 
2.0 
If you check any of the items below, the study is qualified for EXPEDITED review status under 
federal guidelines. 
* Select all that apply: 
 
1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met: 
(a) Research on drugs for which an investigational new drug application (21 CFR Part 
312) is not required. 
(b) Research on medical devices for which an investigational device application (21 CFR 
812) is not required OR the medical device is cleared/approved for marketing and the 
medical device is being used in accordance with its cleared/approved labeling. 
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 
 
(a) From healthy, non-pregnant adults who weigh at least 110 pounds. [not to exceed 550 ml in an 8 
week period and collection may not occur more frequently than 2 times per week; or 
(b) From other adults and children, considering the age, weight and health of the subjects, the 
Case 
Description 

ID: Pro00003276 
View: 3 Research Design 
 
 
collection procedure, the amount of blood to be collected: The amount drawn may not exceed the 
lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 
2 times per week. 
3. Prospective collection of biological specimens for research purposes by non-invasive means. 
Examples: 
(a) hair and nail clippings in a nondisfiguring manner; 
(b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; 
 
(c) permanent teeth if routine patient care indicates a need for extraction; 
(d) excreta and external secretions (including sweat); 
 
(e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing 
gumbase or wax or by applying a dilute citric solution to the tongue; 
(f) placenta removed at delivery; 
(g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; 
 
(h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more 
invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance 
with accepted prophylactic techniques; 
(i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; 
 
(j) sputum collected after saline mist nebulization. 
4. Collection of data through noninvasive procedures (not involving general anesthesia or 
sedation) routinely employed in clinical practice, excluding procedures involving x-rays or 
microwaves. Where medical devices are used, they must be cleared/approved for 
marketing. (Studies intended to evaluate the safety and effectiveness of the medical 
devices are not generally eligible for expedited review, including studies of cleared medical 
devices for new indications) 
 
5. This research involves materials (data, documents, records, or specimens) that have been collected 
for any purpose including previous research or will be collected solely for nonresearch purposes (such 
as medical treatment or diagnosis). 
6. This research involves the collection of data from voice, video, digital, or image 
recordings made for research purposes. 
 
7. This research will be performed on individual or group characteristics or behavior 
(including, but not limited to, research on perception, cognition, motivation, identity, 
language, communication, cultural beliefs or practices, and social behavior) or will employ 
a survey, interview, oral history, focus group, program evaluation, human factors 
evaluation, or quality assurance methodologies. 
 
Methods & Procedures 
1.0 
* Does this research study involve any of the following: 
 
 
Deception 
 
 
Interview/Focus Groups 
 
Use of Drug, biological, or nutritional (e.g., herbal or dietary) supplement (investigational or FDA 
approved)? 
 
 
Use of medical devices 
 
Prospective Analysis of Specimens 
Name 

ID: Pro00003276 
View: 3.4 Use of Medical Devices 
 
 
 
Banking of Specimens-Data 
 
 
Retrospective use of specimens 
 
 
Audio/Video Recordings or Photographs 
 
 
Honest Broker or other similar service 
None of the Above 
 
 
Medical Devices 
 
1.0 
* Specify all devices used on this study: 
 
Kinova Gen3 Kinova 
Investigational 
Kinova Gen3 
The Kinova Gen3 
Non- 
Assistive 
Robotic 
Manipulator 
Device Not Yet 
Approved for 
use 
Brochure(0.01) Assistive Robotic 
Manipulator is a device 
that was built for 
human-robot interaction 
with flexible 
functionalities to ensure 
better safety and 
performance in any 
research environment. It 
equips discrete 2D and 
3D sensors for vision- 
based applications and 7 
DOF robotic arm for the 
daily object 
manipulation. The 
Kinova Gen3 Assistive 
Robotic Manipulator is a 
commercially available 
robotic research system, 
which will be positioned 
on a commercial electric 
powered wheelchair to 
assist daily manipulation 
tasks. The Kinova Gen3 
Assistive Robotic 
Manipulator will be used 
to object recognition and 
manipulation. The 
Kinova Gen3 Assistive 
Robotic Manipulator can 
be powered using the 
wheelchair batteries and 
wall outlet. The Kinova 
Gen3 Assistive Robotic 
Manipulator has three 
layers of safety. First is 
the mechanical layer, 
which includes soft cover 
of screws, smoothed 
edges and surfaces, and 
padding on connectors 
Significant 
Risk 
Device 
Name 
IDE 
Manufacturer Use of Device 
ber(if 
Num 
Device 
Brochure 
Description of Use 
Risk Level 
d 
Determine 
Applicable) 
by Sponsor 

 
 
and power cables. In the 
unlikely event of a 
power failure, the arm is 
freely movable to 
reposition. The second 
layer is electronic, which 
includes self collision 
prevention, joint limits, 
hard force limits, hard 
speed limits, user 
initiated stops, and force 
compliance, which 
allows the robot to 
elastically bend in under 
certain loading 
conditions. Most 
importantly, the Kinova 
Gen3 Assistive Robotic 
Manipulator does not 
move quickly, providing 
humans time to react to 
the devices movements. 
In addition, the 
manipulator stops when 
the user releases the 
joystick or control 
interface. The third layer 
is the software layer, 
which allows for 
programming of 
constraint spaces 
including slow moving 
and keep-out zones. The 
software layer is unique 
to robotic technologies 
and has potential to 
detect unsafe situations 
before they lead to 
accidents. A significant 
risk device is defined as 
an investigational device 
that: (1) is intended as 
an implant and presents 
a potential for serious 
risk to the health, 
safety, or welfare of a 
subject; (2) is for use in 
supporting or sustaining 
human life and 
represents a potential 
for serious risk to the 
health, safety, or 
welfare of a subject; (3) 
is for a use of 
substantial importance 
in diagnosing, curing, 
mitigating, or treating 
disease or otherwise 
preventing impairment 
of human health and 
presents a potential for 
serious risk to the 
health, safety, or 
welfare of a subject; or 

ID: Pro00003276 
View: 3.8 Audio/Video Recordings or Photographs 
ID: Pro00003276 
View: 4 Research study methods 
 
 
(4) otherwise presents a 
potential for serious risk 
to a subject. The Kinova 
Gen3 Assistive Robotic 
Manipulator does not 
meet the definition of a 
significant risk device as 
it does not meet any of 
the 4 criteria listed 
above. 
 
2.0 
* Describe your plan for storage and control of devices: 
The commercial robotic manipulator is attached to a commercially available electric powered wheelchair 
which will be stored in our testing laboratory. Prior to testing, the participants will be thoroughly informed 
about the device and instructed in its use through training sessions. At least one investigator will be present 
at all times when the device is in use. 
 
 
3.8 Audio/Video Recordings or Photographs 
1.0 
* Please provide a description of the audio and/or visual recordings or photographs and who will 
have access to them: 
The performance test with functional tasks using the default control and VGS control will be video recorded 
so that they may be viewed by the study team during data analysis to confirm the user performance data 
collected. Investigators will make every attempt to video record from the neck down to maintain 
confidentiality; if, however, the subject’s face be inadvertently included, investigators will blur out the 
subject’s face during analysis and prior to any future use. Only VAPHS study members will have access to 
these videos. 
The interviews with participants at the end of the study will be audio-recorded for later transcription and 
data analysis. Only VAPHS study members will have access to these audios. 
 
2.0 
* Please describe why this study could not be done without collecting this information in this 
manner: 
Videos will be used to serve as a reference when analyzing the data. Without video, we would not be able to 
accurately assess user performance during data analysis. 
Audios will be used for later transcription and data analysis. Without audio, we would not be able to capture 
all the comments and suggestions provided by the participants. 
 
3.0 
* Please specify your plans for deidentifying or anonymizing the material and when it will be 
destroyed: 
Videos and audios will be captured electronically and files will be named, stored and maintained as 
described in Section 10: Data Security and Privacy. 
 
Research Study Methods 
 
Describe all study related procedures following enrollment of a subject in this study. 
 
Please see Section 6 for where the study team defines when a subject will be considered enrolled in the 
study. 
1.0 
* Research Procedures/Interventions: 
 
 
All research activities will be performed in a controlled environment at the Human Engineering Research 
Laboratories (Bakery Square Location) or at participants’ home by the study investigators comprised of 
research 

engineers, clinicians, and a study coordinator. The testing session will consist of one visit of no more than six 
hours or can be conducted in multiple lab or home visits of 2-3 hours which add up to no more than 6 hours. If 
a participant cannot commit to a total of 6 hours, they will be given the option of one 3-hour visit. 
 
Informed consent will be obtained verbally after eligibility screening or onsite. Participants will then complete a 
questionnaire that includes questions about general demographics, injury and health information, and assistive 
technology experience. They will also complete a SCI-FI self-care. These two assessments can be done via 
phone or in-person. In addition, we will administer MoCA, the Paper Folding Test and Cube Comparison Test. 
SCI-FI Sel-care is a validated patient-report outcome measure of physical functioning related to self-care for 
persons with SCI or other physical disabilities. The Paper Folding Test examines a person’s spatial 
visualization ability by asking him/her to imagine the folding and unfolding of pieces of paper. MoCA is a 
cognitive screening test designed to assist health professionals in the detection of mild cognitive impairment. 
The Cube Comparison Test examines a person’s spatial orientation ability. These user characteristics may 
influence their performance with the ARM control. 
 
Participants will go through a training procedure following the training guide provided by Kinova Robotics. 
During the training phase, a Kinova Gen3 ARM will be mounted onto a table where the training exercises are 
set up. There will be two training sessions. The first training session will explain the basic operation principle of 
the ARM, where participants will learn to operate the ARM and practice the basic movements of the adaptive 
Wolf Motor Function Test (WMFT) for ARM (i.e., move the ARM to table, on top of the box, pick up a cup, 
simulate drinking, put the cup back to the top of box). They will be given opportunities to try different control 
interface options. They will start with the method they use to control their power wheelchair and be allowed to 
explore other options such as the touch interface. This session will last for about one hour. At the end of the 
training, a pretest will be performed to determine participants’ eligibility for the subsequent experimental test 
procedures. Participants will be asked to perform three simple tasks on a task board including pushing a large 
round button, flipping a toggle switch, and pushing down a door handle. If participants can complete each task 
within 2 minutes, they will be considered eligible for participating in the study and move to the next training 
session. Otherwise, more practice and training will be provided. Investigators may also decide whether a 
participant has proficient skills to move onto the next session or if the trial should be concluded. The 
2nd training session will explain more advanced features of the ARM such as the singularity avoidance system 
and obstacle avoidance, and we will also introduce the VGS control with fiducial markers and adaptive tools. 
This session will last approximately 1.5 hours. After training, we will install the ARM to the participants’ 
wheelchairs, on a table, or on an upright stand and configure the control interface for them as needed. 
 
Prior to testing, participants will be asked to rate tasks in a task list in terms of type of assistance needed, 
levels of difficulty, and levels of satisfaction. They will then be asked to select 5-10 tasks that they cannot 
complete on their own. They will then complete the selected tasks with two interventions, i.e., default control 
and VGS control (including fiducial markers and adaptive tools). The tasks will be randomly presented to each 
participant and the sequence of the two interventions will be counterbalanced using a cross-over design to 
minimize order and carryover effect. There will be a break after each intervention and participants can also 
request resting periods at task transitions. The testing session will last about 2 hours. The testing session will 
be video recorded so that they may be viewed by the study team during data analysis to confirm the user 
performance measures. We will collect the following measure for each intervention. 
• 
Task completion time: The time it takes to complete each task successfully. A maximum duration will 
be assigned to each task based on the prior bench-top testing. Participants will be asked to stop the 
task when the maximum duration is reached. 
• 
Mode Switching Frequency: The number of times a participant has to switch modes for task 
completion based on logged control commands. 
• 
Robot Pause Time: The total time when the robot is not moving. 
• 
Success rate: The number of tasks out of the selected tasks that can be completed successfully within 
the maximum assigned time. 
• 
NASA Task Load Index (TLX): NASA TLX will be used to assess the subjective workload of 
participants after each intervention. It has been shown to be valid and has excellent test-retest 
reliability. It consists of six dimensions: mental demands, physical demands, temporal demands, 
performance, efforts, and frustration. Twenty-step bipolar scales are used to obtain ratings on these 
dimensions, resulting in a score between 0-100. The overall task load index will be a weighted average 
of all six dimensions, where the weight for each dimension is obtained through pairwise comparisons 
of these dimensions. The higher score indicates a higher workload. 
• 
System Usability Scale (SUS): SUS will be used to collect perceived ease-of-use after each 
intervention. It provides a global measure of user satisfaction and has been shown to be reliable and 

valid. It consists of 10 statements where users rate on a 5-Likert scale (from 0-strongly disagree to 4- 
strongly agree). Following a suggested formula, a final score between 0-100 will be obtained. The 
higher score indicates better usability and overall satisfaction. 
 
At the conclusion of the study, we will conduct a brief semi-structured interview with each participant and 
obtain more insight on how participants perceive the ease-of-use and usefulness of the VGS control with 
environment adaptations, and obtain suggestions they may have for further development and deployment. The 
interviews will be audio-recorded for later transcription. 
 
 
Please upload a table of procedures if applicable. 
The study procedures table must be completed for: 
- All Greater than Minimal Risk (GTM) studies; and 
- All Minimal Risk studies that use Standard of Care or Usual Care/Interventions. 
 
There are no items to display 
 
2.0 
* Will Usual Care Procedures/Interventions be used?" 
Yes 
No 
 
If yes, please specify and include a description of what the usual care or expected level of care is at VAPHS 
(e.g., medications, testing, timing, etc.) for patients, similar to those individuals that meet the 
inclusion/exclusion criteria for this research study: 
 
2.1 
If Usual Care Procedures/Interventions will be used, who is the individual or entity responsible for relevant 
aspects of the usual care (i.e., which of the above usual care activities will the research study team be 
responsible for)?: 
 
2.2 
Does the usual care at VAPHS for the condition of interest in this research study differ from national 
guidelines/recommendations (i.e. standard of care)? 
Yes 
No 
 
If yes, please describe the differences: 
 
2.3 
Are any procedures that are considered standard for this patient population performed more frequently 
than usual care? 
Yes 
No 
 
If yes, please indicate which time points are considered usual care and which are considered research. 
 
2.4 
If there is more than one standard, does VAPHS limit which one is followed (e.g. warfarin use for atrial 
fibrillation vs. one of the newer anticoagulants). 
Yes 
No 
 
If yes, please explain: 
 
3.0 
* Does clinical expertise need to be enlisted? 
Yes 
No 
 
If yes, please provide the provisions for enlisting the services of a clinician with appropriate expertise and 
privileges to perform duties, if the investigator is not a clinician [i.e. reviewing the data, adverse events, 
Name 
Modified Date 

ID: Pro00003276 
View: 4.1 Research study methods: analysis Plan 
ID: Pro00003276 
View: 5 Sub-Studies 
ID: Pro00003276 
View: 6 Study Population Summary 
and new study findings; also making required decisions to protect the health of the subject (e.g., stopping 
the participant’s involvement in the study or determining when to notify the subject or the subject’s health 
care provider of information that may affect the health of the subject)]: 
4.0   Please upload any surveys, questionnaires, and data collection forms. 
Document 
Description 
Version Number 
View Cube Comparison(0.01) 
0.01 
View Interview Quesions(0.01) 
0.01 
View NASA-TLX(0.01) 
0.01 
View Paper Folding(0.01) 
0.01 
View Questionnaire(0.01) 
0.01 
View Satisfaction(0.01) 
0.01 
View SUS(0.01) 
0.01 
 
1.0 
* Please describe the analysis plan for the study (it is acceptable to refer to the sponsor/multi-site 
protocol for section if applicable): 
Statistical analyses will be preceded by a detailed descriptive analysis of the data, using standard descriptive 
summaries and graphical techniques. The task completion time will be aggregated over the self selected tasks. 
The key variables including the aggregated task completion time, [mode switching frequency], success rate, 
NASA TLX score, and SUS score will be examined to ensure that proposed statistical techniques are suitable. 
Significance level will be determined at 0.05 for all statistical tests. We will first use scatterplots to show each 
participant’s key variables on the two interventions. Different symbols will be used to indicate the order of 
intervention for each participant and the line of equality will be superimposed for ease of interpretation. We 
assume neither carry-over nor period effects would be a problem, thus will use a paired t-test to compare the 
two interventions on all key variables. Qualitative data from the semi-structured interviews will be audio 
recorded and transcribed, and then analyzed using the affinity diagramming technique to extract themes. 
 
 
1.0 
* Is there a sub-study or are there sub-studies associated with this study? 
There is no sub-study associated with this study. 
 
Study Population Summary 
1.0 
* What is the maximum number of subjects you plan to enroll at VAPHS? 
We aim to recruit a total of 21 participants. 
 
2.0 
* Do you plan on enrolling patients into different categories: 
Yes 
No 
 
If yes, please explain: 
 
3.0 
If this is a multi-site study, indicate the projected total subject accrual: 
 
4.0 
* Please provide a justification for the sample size: 
[Based on our preliminary work, in the lab testing condition, the VGS control could reduce the task 
completion time by an average of 30% (ranging from 0.03% for the simple door handle task to 55% for the 
relatively difficult knob turning task). The functional tasks in our task list will contain more complex tasks, 

ID: Pro00003276 
View: 6.1 Study Population 
ID: Pro00003276 
View: 6.1.1 Non-Veterans 
thus we can reasonably assume at least 20% reduction in task completion time when using the VGS control 
as opposed to the default control for this power analysis.] Given an alpha of 0.05, a 20% reduction in task 
completion time, and a 25% standard deviation in the difference between the two interventions, we will 
need 12 participants to obtain 80% power for the study. We will, therefore, recruit 16 participants to 
account for attrition for the lab testing session. For the home testing session, since this is a pilot study, 
there is no prior data from our group and published paper. Thus, it is not applicable to calculate a power 
analysis. We aim to recruit 3-5 participants to assess the feasibility and collect preliminary date. Power 
analysis was performed using the G*power 3.1.9.2. 
 
Study Population 
 
1.0 
* Check all that apply to describe your study population: 
 
 
Non-Veterans 
 
 
Special Populations 
 
 
Veterans 
 
 
Vulnerable populations 
Other 
 
2.0 
* Indicate the inclusion criteria for enrollment: 
The inclusion criteria are (1) 18 years of age and older; (2) using a power wheelchair as primary means of 
mobility; (3) having self reported difficulties in performing everyday manipulation tasks such as reaching for 
a glass of water, opening a refrigerator, and picking up a toothbrush. 
 
3.0 
* Indicate exclusion criteria for enrollment: 
The exclusion criteria are (1) people with impaired vision; and (2) people with pressure ulcers that prevent 
them from sitting continuously for an extended period of time. 
 
4.0 
If there are any age, ethnic, language, or gender-based exclusion criteria, including the 
exclusion of any pregnant or lactating women, or those of child-bearing potential, please provide 
justification: 
We would like to recruit participants who are 18 years of age and older, as the control method and tasks are 
designed for adult users instead of pediatric users. 
 
5.0 
Please specify why vulnerable subjects and/or special populations will not be enrolled: 
 
6.0 
With some exceptions as listed in VHA Handbook 1200.05, incompetent subjects cannot be 
enrolled in VAPHS approved research. Specify that you will not enroll incompetent subjects and 
the general rules to be used in making that determination: 
Incompetent subjects will not be enrolled in this study. Competency will be determined based on whether or 
not the subject is able to provide informed consent by effectively communicating with study investigators. 
 
Non-Veterans 
1.0 
* Target number of participants: 
21 
Study Population 

2.0 
* Describe why you cannot complete enrollment in this study without the use of Non-Veterans: 
1. Specify why you require Non-Veterans in your study. Include information in your justification related to 
your study aims/goals; What role will the Non-Veteran population have in the study? 
 
Given the nature of this research, which focuses on individuals who have limitations with activities of daily 
living, who use an electric powered wheelchair as primary source of mobility, our recruitment pool is small. 
There are insufficient Veterans available to complete this study in accordance with 38 CR 17.45 and 38 CFR 
17.92. This necessitates recruiting both veterans and non-veterans for our research. 
 
 
2. Provide information as to why there are insufficient Veterans suitable for this study. Include proof, 
whether through statistics, or another method, that you have used your resources in a good faith effort to 
enroll Veterans; Example- ‘We are studying a rare disease that affects a very small population, in which 
Veterans would be an even smaller portion of that population.’ *Provide the appropriate diagnostic statistics 
to support this* 
 
We will need to recruit n=21 subjects to have sufficient power to obtain statistically significant data as to 
the superior performance of our custom vision-based control. We have only 19 Veteran participants in the 
HERL research registry that live within Pennsylvania and use a power wheelchair for the majority of their 
mobility. Of these registry participants, not all live close enough to Pittsburgh to participate, meet the 
inclusion/exclusion criteria or will want to participate in this study. Also, the information obtained from this 
study could be generalized to benefit the well-being of all power wheelchair users, including veterans. 
According to VHA Directive 1200.01 non-veterans may be recruited when there are insufficient veterans 
suitable for the study. According to the HERL research registry, we find this to be the case. We, therefore, 
would need to enroll non-Veterans to get statistical power for the study. However, we will also make every 
effort to actively recruit veterans into this study. 
 
3. Provide information about how the inclusion of the Non-Veteran population will fulfill/remain consistent 
with the VA Mission. Explain how including Non-Veterans will enhance your study, yet still pertain to the 
Veteran population. 
 
VA's Mission is to fulfill President Lincoln's promise: "To care for him who shall have borne the battle, and 
for his widow, and his orphan" by serving and honoring the men and women who are America's Veterans. 
 
We believe the study results will provide knowledge base to help expand the manipulation capability of 
veterans with disabilities who use electric powered wheelchairs and improve their independence with 
activities of daily living. 
 
4. How will the inclusion/recruitment of Non-Veterans benefit Veterans and their well-being? 

ID: Pro00003276 
View: 7 Risk/Benefit Assessment-Risks 
Name 
It is necessary for us to include the veterans and non-veterans to increase the sample size and generalize 
the results to people who use electric powered wheelchairs as a primary source of mobility. We will meet 
the aims of the study, by enrolling veterans and non-veteran wheelchair users and having them test the our 
custom vision-based control for the assistive robotic manipulator. 
Please upload the Inclusion of Non-Veterans Worksheet here: 
 
3.0 
* If your study is a clinical trial, please indicate where the VHA Notice of Privacy Practices (VA 
Form 10-0483) will be stored once signed: 
Not applicable. 
 
Risk/Benefit Assessment-Risks 
 
1.0 
* Risk classification for this study (select one). 
 
Minimal Risk 
 
Greater than Minimal Risk 
 
 
2.0 
* Basis for making the above recommendation: 
1. Participants will evaluate a new control approach for an off-the-shelf wheelchair-mounted robotic arm for 
a series of everyday functional tasks, and thus will not be exposed to greater risks than what they 
experience in everyday life. 
2. There is a risk of breach of confidentiality. 
 
3.0 
* Describe the safety precautions that will be taken to minimize risks/harms: 
There is the risk that the device/control could malfunction. To minimize this risk, the investigators will be 
working in close proximity to the subjects and provide supervision as needed. The device is designed to 
operate under slow speeds and allows investigators to specify safety zones where the arm cannot reach. In 
addition, safety switches are installed and investigators have the ability to completely shut down the 
operation of the device for any reason. Thus, no physical injury (e.g., swinging around and hitting the 
subject) can occur using this device. 
 
Participants may experience frustration while learning to use a new device. Subjects will be provided with 
extensive training and also be informed that they may take a break and/or discontinue the study at any 
time. Subjects will also have the option to decline to complete a task if they are unable or choose not 
to. 
 
In the home testing scenario, there are risks of damage to the testing objects and leaving tape trails on the 
object. To minimize the risk, no fragile items will be used as testing objects; also, the investigators will be 
working alongside the participants, giving instructions on robotic arm operation to avoid damage. In 
addition, no residue tape will be used for taping the fiducial tags to reduce the risk of leaving the tape 
marks on the object. 
There is a potential risk for a breach of confidentiality from completing the questionnaires, the video 
recording during the testing session, and audio recording of the exit interviews. To minimize this risk, only 
associated research staff will have access to identifiable study information. Research activities that are 
video recorded will be recorded from the neck down. If someone's face is inadvertently included, 
investigators will blur out the subject's face prior to future use. 
 
4.0 
* Provide details regarding the nature of each risk using the area provided below: 

ID: Pro00003276 
View: 7.1 Risk/Benefit Analysis-Potential Benefits and Alternatives 
ID: Pro00003276 
View: 8 Methods of Recruitment and Retention 
 
View Interviews 
View Research activities 
 
View Questionnaires 
 
5.0 
* Do you plan on using the research answering service: 
Yes 
No 
 
If yes, please Upload the research answering service form: 
 
6.0 
If your study involves a treatment or intervention, please upload the Patient ID Card: 
 
Risk/Benefit Analysis-Potential Benefits and Alternatives 
Describe any potential for benefits to participants in this study: 
1.0 
* Direct and Indirect Benefits to Subjects: 
There are no direct benefits to participants in this study. 
The proposed work may benefit society by maximizing the potential of ARMs in assisting Veterans with 
everyday manipulation tasks and supporting the adoption of this advanced assistive technology. The use of 
enhanced ARMs in home and community could potentially lead to improved independence and the ability of 
Veterans with upper limb impairments to integrate into the community, as well as reduced attendant care 
need and cost. 
 
2.0 
* Describe alternatives (research or non-research) that are available to subjects if they choose 
not to participate in this study: 
Alternative to participate is not to participate in this study. There also may be other projects the individual 
may qualify for. 
 
 
Recruitment Methods and Materials used for Retention 
1.0 
* Select recruitment methods used on this study: 
 
 
Mail Campaign 
 
 
Referral by independent source 
 
 
Advertising such as fliers, letters, or ads (newspaper, TV, radio) 
 
Web Site 
 
 
Research registry 
 
 
Selected from pre-existing records 
 
 
Pre-existing relationship with participants 
 
Other 
 
 
If Other Methods Specify: 
 
2.0 
* Specify how subjects will be identified and how study eligibility will be determined: 
As stated on pg. 11 of the grant, subjects will be recruited through IRB approved registries developed by 
the Human Engineering Research Laboratories and the Department of Physical Medicine and Rehabilitation. 
Risk Name 
Name 

ID: Pro00003276 
View: 9 Informed Consent 
They also can be recruited through Pitt+Me. All registry participants have provided informed consent to be 
contacted for future research studies. 
All registry participants have provided informed consent to be contacted for future research studies. The 
IRB approved flyer for this study will be provided to the registry investigators to distribute to potential 
subjects according to the procedures established in the registry IRB approved protocols. In response to the 
flyer, potential subjects will directly contact the research team if interested in participating. 
 
We also plan to recruit through distributing the recruitment flyer to rehabilitation facilities throughout the 
UPMC Center for Assistive Technology (CAT) and VAPHS. Potential subjects recruited through the CAT and 
VAPHS wheelchair clinic will be approached by their treating provider, asked if they would like to participate 
and will be given a flyer. The recruitment flyer mentioned is the same as above. We also intend to utilize 
the VAPHS Facebook page to post a flyer. Participants may also be recruited by placing flyers at 
informational tables sanctioned by the VAPHS Research Office. Study team members may elect to sit at the 
informational tables to provide information and enroll participants. 
 
Flyers may be posted in local rehabilitation facilities, outpatient facilities, and disability organizations. 
Participants may also be recruited via flyers in print media (magazines, newspapers, newsletters). The flyer 
may also be posted on the HERL website. The flyer instructs potential subjects to contact HERL for 
additional information. No recruitment materials will be used without IRB approval. Subjects who wish to 
participate will call the laboratories and be scheduled for testing. 
Individuals who are participating in other research studies at HERL may be given the study flyer and asked 
if they would like more information. If yes, the individual may be introduced to a member of the research 
staff. 
 
 
3.0 
* Provide the location (or locations) of the sites where participants will be recruited: 
VAPHS, HERL, UPMC Center for Assistive Technology (CAT) 
 
4.0 
Please include information regarding any advertisements (print, TV, radio, etc) that will be used 
to recruit subjects including a general description of where this information will be posted: 
The flyer may be used in print media (magazines, newspapers, newsletters) and web-based postings. Flyers 
may be posted in local rehabilitation facilities, outpatient facilities, and disability organizations. The 
advertisement will be posted on the HERL website (www.herl.pitt.edu). The flyers instruct potential subjects 
to contact HERL for additional information. 
 
5.0 
Please UPLOAD the documents that will be used for recruitment and an introductory statement 
or letter to accompany consent for those studies obtaining written informed consent using 
methods such as fax, email or mail (if applicable). Please also upload any screening/recruitment 
questions that will be verbally asked of potential research subjects. Also, if you will be providing 
any retention materials, please upload them here. 
 
Name 
Reviewer 
Modified Date 
Version Number 
Public Affairs Office Approval 
Post, Daniel Robert 
11/21/2019 1:44 PM 
0.01 
VGS Flyer-converted.docx 
Post, Daniel Robert 
11/21/2019 1:43 PM 
0.02 
 
 
Informed Consent 
 
1.0 
* Indicate the types of consent that will be involved in this study (check any or all that apply): 

ID: Pro00003276 
View: 9.1 Waiver of HIPAA 
 
Written/signed consent by subject 
Waivers are being requested. 
Verbal consent or written information sheet(Requires a Waiver of Documentation of Informed Consent - see 
below) 
 
2.0 
* Waivers: If you are applying for any waivers of consent (check any or all that apply): 
 
 
Waiver of Informed Consent 
 
 
Waiver of HIPAA Authorization 
 
 
Waiver of Documentation of Informed Consent ( telephone consent, verbal script) 
 
No Waiver at all 
 
 
3.0 
* Will this study include non-English speaking participants? 
Yes 
No 
 
You have indicated you are requesting a waiver of HIPAA. 
 
 
1.0 
* Is the request only for Screening/Recruitment purposes? 
Yes 
No 
If yes, please describe your screening/recruitment method: 
 
 
If no, the request is for the full study (e.g. retrospective chart reviews and certain observational studies) 
 
We are requesting a waiver to allow us to conduct a brief phone screening of potential subjects who contact 
HERL and express an interest in the study. The screening will assist in determining potential subject 
eligibility prior to scheduling an appointment. Verbal consent for screening will be obtained and documented 
on the screening script. We are also performing some initial surveys via phone before the participant comes 
onsite that will ask some basic demographic and health information. 
Please describe the types of records and/or databases to be accessed: 
THE IDENTIFIABLE INFORMATION BEING REQUESTED: 
Note: If participants will be receiving payment and HIPAA Authorization is not being obtained, you must select 
Names, Addresses and Social Security Numbers as that information will be disclosed for payment purposes. 
2.0 
* Identifiable Information per HIPAA Definition 
 
 
None 
 
 
Account numbers 
 
 
Biometric identifiers, including finger and voice prints 
 
Certificate/license numbers 
 
Device identifiers and serial numbers 
Informed Consent Category 
Name 
Name 

 
 
Elements of dates (except year, for example, date of birth, admission date, discharge date, date of 
death, date of procedures; and all ages over 89) 
 
Email Address 
 
Fax Numbers 
 
 
Full-face photographic images or any comparable images 
 
Geographical subdivisions smaller than a State (street address, city, county, precinct, zip code, and 
their equivalent geocodes, except for the initial three digits of a zip code) 
 
 
Health plan beneficiary numbers 
 
 
Internet Protocol (IP) address numbers 
 
Medical Record Numbers 
 
 
Name or any derivative of name such as initials 
 
 
Social Security Numbers 
 
 
Telephone Numbers 
 
 
URLs (Web Universal Resource Locators) 
 
 
Vehicle identifiers and serial numbers, including license plate numbers 
 
Any other unique identifying number, characteristic, or code (Note: The study ID number, code or 
other means of record identification is not considered one of the identifiers that must be excluded for 
de-identification) 
 
3.0 
* Patient Protected Health Information: 
 
 
Demographic Information (e.g., Name, Address, Phone Number, Social Security Number 
 
 
Billing and Payment Information 
 
Hospital or Medical Records 
 
 
History and Physical Exam Notes 
 
Mental Health Records 
 
Data Previously Collected for Research Purposes 
 
Progress Notes 
 
 
Consultation Reports 
 
 
Laboratory Test Results 
 
Operative Reports 
 
Other 
 
 
Please indicate the 'Other' Patient Protected Health Information: 
difficulties in every day life; impaired vision; history of pressure sores; age 
 
4.0 
Other Health Information: 
 
There are no items to display 
Name 
Name 

 
Waiver of HIPAA- More Information 
1.0 
* Describe how the identifiable information is to be used and/or disclosed only by members of 
the research team and the following persons (identify with specificity and justify the need to 
disclose the information to anyone outside the VHA.) Note: If participants will be receiving 
payment and HIPAA Authorization is not being obtained, you must also describe this disclosure 
to representatives of the VA for administrative purposes here. 
 
Also describe how this activity meets the “minimum necessary standard” described in the HIPAA 
Privacy Rule: 
For those subjects who contact an investigator via phone to inquire about participation, a telephone 
screening script will be administered. For the purposes of scheduling, the participant’s name and contact 
information will be recorded. 
The proposed study poses minimal risk to the privacy of the subjects because... 
2.0 
* Describe how the identifiable information will be protected from improper use or disclosure by 
(detail how this will be accomplished including the limitations of physical or electronic access to 
the information and other protections): 
This information will be stored in a secure file room in the Human Engineering Research Laboratories with 
restricted access. Access to the file room is limited to the PI and associated research staff. Electronic 
information will be on a secure survey with only access to associated research staff and the PI. 
 
3.0 
* Describe how the identifiers will be destroyed at the earliest opportunity consistent with the 
research (discuss the timeframe or the reasons the identifiers must be retained, including health 
or research justifications or any legal requirement to retain them) (Note: At this time, identifiers 
used for research screening and all other screening records must be retained indefinitely and 
this must be documented by checking “Other” below): 
If the participant is eligible to participate, their information will be stored in their research file or 
electronically. If the participant is not eligible to participate, contact information will not be collected. 
 
* When will screening data be de-identified or destroyed: 
 
Other 
If Other, please describe: 
All research records will be maintained in accordance with the Veterans Health Administration (VHA) 
Records Control Schedule. Paper records will be disposed of using methods deemed appropriate by the 
VAPHS Privacy Officer, and all electronic data will be sanitized using methods rendered appropriate by the 
VAPHS ISO. 
 
4.0 
* Describe how the identifiable information will not be reused or disclosed to any other person 
or entity outside the VHA other than the manner described in the protocol, except as a required 
by law, for authorized oversight of this research study, or as specifically approved for used in 
another study by an IRB: 
This information will be stored in a secure file room in the Human Engineering Research Laboratories with 
restricted access. 
 
5.0 
* Describe why the proposed study cannot be practicably conducted without a waiver of 
authorization: (discuss reasons why it would not be possible to obtain authorization from 
individual subjects. Time constraints themselves are generally not considered adequate for this 
justification: 
Screening is done via the telephone. It would not be practical to mail out the HIPAA authorization to 
potential participants who contact us prior to asking a few questions to determine potential eligibility. The 
option of conducting initial surveys via phone will also be available to help with recruitment and decrease 
onsite participation time. Individuals who potentially qualify will subsequently be scheduled to sign an 
informed consent form and HIPAA authorization. If they do informed consent via phone, they will sign the 
standalone HIPAA authorization onsite. 
 
6.0 
* Describe why the proposed study cannot be done without the specified identifiable 
information: Discuss reasons why it would not be possible to conduct the research without the 
ID: Pro00003276 
View: 9.1.1 Waiver of HIPAA - More Information 
Name 

ID: Pro00003276 
View: 9.3 Waiver of Documentation of Informed Consent 
identifiable information being collected. 
Contact information is collected for eligible subjects for scheduling purposes only. We are also asking 
screening questions to determine eligibility. We want to confirm that the participant meets the eligibility 
criteria before being scheduled for testing to reduce the risk of participants traveling to the research lab, 
only to learn they are not eligible to participate. 
 
 
Waiver of Documentation of Informed Consent 
You have selected a waiver of Documentation of Informed Consent 
1.0 
This is a request for Waiver of Documentation of Informed Consent because this research study 
conforms to either A and/or B (Check if ‘yes’ and provide the verifying information requested): 
* A: The only record linking the subject and the research would be the consent document and the principal 
risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether 
the subject wants documentation linking the subject with the research, and the subject's wishes will 
govern.    Yes   No 
 
 
 
AND/OR 
 
 
 
* B: The proposed study poses minimal risk to the subjects.    Yes   No 
 
If yes, please explain why the proposed study poses minimal risks to the subjects. (Outline the subject’s 
involvement in the project and why the study poses minimal risk) : 
The waiver of documentation of informed consent will cover screening procedures, and questionnaires that 
can be performed over the phone that include questions about general demographics, injury and health 
information, and assistive technology experience. They will also complete a SCI-FI self-care. These two 
assessments can be done via phone or in-person, but if selected to do via phone, it will be after verbal consent. 
The information collected during screening is minimal and limited to what's necessary to verify eligibility. 
The study is minimal risk because participants will not be doing any activities they would not normally do on 
a day to day basis. 
 
2.0 
* The research involves no procedures for which written consent is normally required outside of 
the research context. Research procedures include: 
Information regarding the research study will be provided and if interested, the participant will be asked to 
answer several eligibility questions. If time allows, they will also be asked to complete initial surveys via 
phone. The information collected is used to verify eligibility. Questionnaires include basic demographics, 
injury information, SCI-FI and assistive technology experience. Any contact information needed will only be 
used to schedule an appointment for research participation. Basic demographic and contact information 
collected during the screening procedure presents no more than minimal risk and would not require 
informed consent outside of the research context. If the individual is deemed ineligible, the screening script 
used for this person will be stored securely within a locked file room at the Human Engineering Research 
Laboratories. 
We are requesting a waiver to allow us to conduct a brief phone screening of potential subjects who express 
interest in participating in this research study. The waiver also allows completion of the demographic 
questionnaire and SCI-FI self-care survey via phone. This information will be stored in a locked secure file 

ID: Pro00003276 
View: 9.4 Consent Forms & Process of Consent 
room in the Human Engineering Research Laboratories with restricted access, and electronic forms will be 
saved on the secure network drive. Access to the file room is controlled by the Clinical Coordinators and 
will be limited to the PI and associated research staff. 
 
3.0 
* Explain how whenever appropriate, the subjects will be provided with additional pertinent 
information (e.g. an information sheet): 
The participant will have the opportunity and will be encouraged to ask questions during the screening 
procedures. When the participant comes onsite, they will be provided with a hardcopy of the consent form 
for their records. Participants that consent verbally will also be required to sign a HIPAA authorization 
onsite. 
 
4.0 
Please upload SCRIPT here: 
Document 
Description 
Version Number 
View VGS Screening Script_VA IRB clean version(0.05) 
0.05 
 
 
 
Consent Forms & Process of Consent 
 
1.0 
Upload the completed forms into the correct lists below. 
 
1.1 
Informed Consent Form (clean copy): 
View VGS ARM Consent(0.07) 
1/3/2020 12:00 AM 
0.07 
1.2 
Provider Behavior Informed Consent Form (clean copy): 
There are no items to display 
1.3 
Screening Informed Consent Form (clean copy): 
There are no items to display 
2.0 
Consent Forms (modified copy): 
View track change version(0.02) 
1/3/2020 5:11 PM 
0.02 
 
3.0 
* Describe how, where, when, and by whom the consent process will be initiated: 
Written informed consent will take place at HERL using the VA IRB approved consent form. If possible, the 
participant will be given the option of doing a verbal consent for performing initial surveys by phone. The 
following procedures will be followed: 
Potential subjects will be provided an explanation of the purpose of the research, why they are being asked 
to participate, and the duration of the study. In addition, the potential participant will be made aware of any 
foreseeable risks associated with the study as well as any potential benefits. Potential participants will be 
made aware of the alternative to participation in the study and the methods used to protect the 
confidentiality of the records during the study. Also, subjects will be told that their participation in this study 
is completely voluntary and that they can withdraw at any time. Information on who to contact if they were 
to have any questions, concerns, or complaints about this research will also be provided. Subjects will also 
be asked if they understand the purpose, risks and benefits, procedures, and their rights as a research 
subject. Any questions the subjects have at any time will be answered by one of the listed research staff. 
The entire process will occur prior to obtaining written informed consent. The principal investigator or a 
study team member of this study will be involved in the consent process described above. The consent 
process will take place in a private location at HERL or via phone 
 
4.0 
* Will you be maintaining a Master List of Subjects? 
Yes 
Document 
Modified Date 
Version Number 
Document 
Modified Date 
Version Number 
Document 
Modified Date 
Version Number 
Document 
Modified Date 
Version Number 

ID: Pro00003276 
View: 10.0.0 Data Security and Privacy: Data Types Storing 
5.0 
* Describe when the subject’s name will be added to the master list and how the list will be 
maintained in a secure fashion. 
Only once verbal consent has been obtained from the subject and it has been documented, will the study 
subject’s name be added to the master list of subjects. The master list will be secured in compliance with all 
VA confidentiality and information security requirements. 
 
10.0 Data Types Collecting and Storing 
1.0 
Click the add button (below) to open an entry form to indicate the types and/or sources of the 
data that will be collected/stored as part of the project. 
 
Instructions: For each type/source of data that will be collected as part of the project, this 
includes screening data, click the add button to open an entry form that lists the types and/or 
sources of data. Select a source/type of the data that will be collected/stored. Then indicate 
what, if any, identifiers or sensitive information will be collected/stored from the source/type 
(None is an option). To add another source/type click “OK Add Another” button to open up a 
new entry form to repeat the process. 
 
Example 1: You are collecting data from VA Medical records including names, last 4 of SSN, and 
addresses. Therefore, you would select “VA medical record data” as the source, and then select 
in the identifiers: “Name or any derivative of name, such as initials,” “Social Security Numbers,” 
and “Geographical subdivisions smaller than a State (street address, city, county, precinct, zip 
code, and their equivalent geocodes, except for the initial three digits of a zip code)” as the 
identifiers being collected. 
 
Example 2: You are screening VA Medical Records and recording the information you use to 
screen (i.e.: names, last 4 of SSN, and addresses, etc.) Note: This information must be treated 
as a Source document, please select “Screening” as the source and then select the identifiers 
“Name or any derivative of name, such as initials,” “Social Security Numbers,”, as applicable. 
 
 
* 
 
View Audio or video 
recordings 
 
 
 
 
 
 
 
 
 
View Other 
Data from study device 
Data will be collected at 
VAPHS 
 
 
 
 
 
 
 
 
 
Usage data from 
assistive robotic arm 
during the laboratory 
• 
Any other unique 
identifying number, 
characteristic, or code 
(Note: The study ID 
number, code or other 
means of record 
identification is not 
considered one of the 
identifiers that must 
be excluded for de- 
identification) 
• 
None 
Data Type/Source 
Collection Details 
Identifiers 

ID: Pro00003276 
View: 10.1.0 Data Security and Privacy: Incoming Data 
testing will be collected 
at VAPHS. 
View Questionnaires/Surveys, Data will be collected at 
 
 
• 
Any other unique 
paper 
 
 
 
 
 
 
 
 
 
View Other 
Consent form/HIPAA 
Authorization 
VAPHS, or via phone. 
 
 
 
 
 
 
 
 
 
Data will be collected 
during the process of 
obtaining informed 
consent. Only the last 4 
digits of the Social 
Security number will be 
collected. Data will be 
collected by approved 
research staff. HIPAA 
authorization will be 
signed onsite if the 
participant does verbal 
consent via phone. 
identifying number, 
characteristic, or code 
(Note: The study ID 
number, code or other 
means of record 
identification is not 
considered one of the 
identifiers that must 
be excluded for de- 
identification) 
• 
Elements of dates 
(except year, for 
example, date of birth, 
admission date, 
discharge date, date 
of death, date of 
procedures; and all 
ages over 89) 
• 
Telephone Numbers 
• 
Social Security 
Numbers 
• 
Name or any 
derivative of name 
such as initials 
 
 
10.0.1 Data Security and Privacy: Social Security Numbers 
1.0 
You indicated that you will be using all or some part of the research subjects' SSNs as part of 
this study. Which of the following will you be using: 
Real Social Security numbers 
* 
 Yes 
 No 
Scrambled Social Security numbers  * 
 Yes 
 No 
Last 4 digits of Social Security Number * 
 Yes 
 No 
Other (some derivation of the SSN)  * 
 Yes 
 No 
If other, please explain: 
 
2.0 
* Please describe how subjects’ Social Security numbers will be used in this study: 
The last 4 digits of the subjects' social security number will be collected on the informed consent document 
and the HIPAA Authorization form. The full SSN and bank account number will be used by the VA to issue 
EFT payment. 
 
3.0 
* Please describe the security measures that will be taken to protect SSNs. 
This information is collected as required. The security measures that will be taken to protect SSNs are the 
same as those applied to all study data. The HIPAA authorization will be stored securely within a locked file 
room at the Human Engineering Research Laboratories. Paper documents will be stored in room 4103 of 
the Human Engineering Research Laboratories. 
 
10.1.0 Incoming Data 
 
1.0 
* Will data be transferred into VAPHS? 
No. Data is not being transferred into this facility 
ID: Pro00003276 
View: 10.0.1 Data Security and Privacy: Social Security Numbers 

ID: Pro00003276 
View: 10.3.0 Data Security and Privacy: Local Data Storage Types 
ID: Pro00003276 
View: 10.3.1 Data Security and Privacy: Local Data Storage Types - Paper 
ID: Pro00003276 
View: 10.3.2 Data Security and Privacy: Local Data Storage Types - Electronic 
ID: Pro00003276 
View: 10.4.0 Data Security and Privacy: Reusing Data 
 
10.2.0 Outgoing Data 
 
1.0 
* Will any of the data being collected/stored be transferred outside of VAPHS? 
No. The data is not being transferred outside of this facility. 
 
10.3.0 Local Data Storage Types 
 
1.0 
* How will data be stored on this project? (Select all that apply) 
On Paper 
Electronically 
 
10.3.1 Local Data Storage Types - Paper 
 
1.0 
* All VA research data collected in paper must be stored in a locked room at VAPHS. 
List the room number(s) and the campus(es) where data will be stored in the text box below. 
Paper documents will be stored in room 4103 of the Human Engineering Research Laboratories. Room 4103 
is a double locked file room where HERL stores all VA data. Access to this room is limited to only clinical 
coordinators. 
 
10.3.2 Local Data Storage Types - Electronic 
 
1.0 
* Where is the electronic data being stored? Select all that apply. 
 
VAPHS Network (shared drive) 
VA redcap 
 
 
 
If "Other" please describe OR if you would like to provide additional information for clarification, 
please elaborate in the text box below. 
 
 
If you selected VAPHS or VA Network (Shared Drive), please provide the name of the drive (i.e. 
"MySharedDriveName (\\vapthshsare) (X:)"): 
\\oitpthhsmsvm200.v04.med.va.gov\Research\Ding_Pro3276_VGS_ARMS_542 
 
10.4.0 Data Security and Privacy: Reusing Data 
1.0 
* Will the data collected in this study be reused in other studies? 
Yes 
No 
 
If yes, please describe where the data to be reused will be stored and how access to that data 
will be provided and monitored: 
The final data set will be maintained at VAPHS share drive (\\vhapthmulherl07\HERL07\HERL07\HERL 
Projects Ding\VGS ARM), until enterprise-level resources become available for long-term storage and 
ID: Pro00003276 
View: 10.2.0 Data Security and Privacy: Outgoing Data 

ID: Pro00003276 
View: 10.6.0 Data Security and Privacy: HIPAA 
Name 
ID: Pro00003276 
View: 10.7.0 Data Security and Privacy: Additional Information 
access. Guidance on request and distribution processes will be provided by ORD. Prior to distribution, a local 
privacy officer will certify that the dataset contains no PHI. 
2.0 
If this research is part of a grant, please upload the Data Management Access Plan (DMAP) or 
Resource Sharing Plan for this study. 
 
DMAP 
11/18/2019 2:04 PM 
 
10.6.0 Data Security and Privacy: HIPAA 
The Healthcare Insurance Portability and Accountability Act (HIPAA) prohibits the use of a person's Protected Health 
Information without a valid authorization. 
1.0 
* Select the option which fits this study: 
 
Not applicable: No PHI is being used or disclosed by VAPHS 
Not applicable: Waiver has been requested 
HIPAA Authorization (Combined Consent and HIPAA Authorization) 
 
HIPAA Authorization (Standalone) 
 
 
 
Upload HIPAA authorization (Standalone) here: 
Document 
Modified Date 
Version Number 
View HIPAA Placeholder(0.01) 
11/18/2019 11:38 AM 
0.01 
 
 
2.0 
At screening will clinical personnel be asked to share potential participants PHI: 
Yes 
No 
 
If yes, please upload the 10-5345: 
 
10.7.0 Data Security and Privacy: Additional Information 
1.0 
Does this research involve... 
 
* ...specially obtained software? 
Yes 
No 
 
If yes, please describe the software and what it is being used for: 
 
 
* ...one or more Web-based applications? 
Yes 
No 
 
If yes, please describe the application and what it is being used for: 
 
 
* ...mobile devices? 
Yes 
No 
Name 
Modified Date 

If you answered yes above, please upload a fully executed VAPHS Memo to Take VA Sensitive Information 
Outside a Protected Environment by following these instructions . 
ID: Pro00003276 
View: 10.8.0 Data Security and Privacy: Certifications 
If yes, please describe: 
A VAPHS video recorder (not mobile device/audio recorder) will be used for video recordings. The video files 
will be stored on a secured server affiliated with Human Engineering Research Laboratories and only be 
made available to personnel involved in the study through the use of access privileges and passwords. 
 
2.0 
* Will a Certificate of Confidentiality be obtained for this study? 
Yes 
No 
If yes, please attach the Certificate of Confidentiality: 
3.0 
* Will VA sensitive information be transported and utilized outside protected 
environments? 
Yes 
No 
 
 
10.8.0 Certifications 
 
1.0 
* I certify that all study staff are up-to-date and will remain up-to-date with Information 
Security Awareness Training, Rules of Behavior, and VHA Privacy Training. 
Yes 
No 
2.0 
* I also certify that when an individual is no longer part of the study team, access will be 
removed to research study data. 
Yes 
No 
3.0 
* I certify that all research records will be maintained in accordance with the Veterans Health 
Administration (VHA)Records Control Schedule. Paper records will be disposed of using methods 
deemed appropriate by the VAPHS Privacy Officer, and all electronic data will be sanitized using 
methods rendered appropriate by the VAPHS ISO. 
Yes 
No 
 
4.0 
* I certify that any loss or compromise of any VA sensitive information (including research 
data), VA equipment or device, or any non-VA equipment or device that is used to transport, 
access, or store VA information will be reported in accordance with the reporting requirements 
outlined in VA Handbook 6500. 
Yes 
No 
 
5.0 
* I certify that, in accordance with VA Handbook 6500, no personal laptops will be used for 
official VA business in conjunction with this study. 
Yes 
No 
 
Local Data Safety Monitoring Plan 
For local studies, a data and safety monitoring plan (DSMP) must be established. 
 
 
1.0 
* Please describe how the study procedures and data being collected will be continuously 
monitored so that changes in the risk/benefit ratio can be determined in a timely fashion during 
the course of the study: 
ID: Pro00003276 
View: 11 Local Data Safety Monitoring Plan 

ID: Pro00003276 
View: 12 Costs and Payments 
ID: Pro00003276 
View: 12.1 Costs 
ID: Pro00003276 
View: 12.2 Participant Payments 
A data and safety monitoring plan will be implemented to ensure that there are no changes in the benefit/risk ratio during 
the study and that confidentiality of research data is maintained. Any instances of protocol deviations or other problems 
identified will be reported as soon as possible within the required reporting time frames using the standard forms and/or 
procedures set forth by the IRB. A data safety and monitoring report will be sent to the IRB at the time of renewal. 
 
2.0 
* Describe how frequently Investigators, study personnel, and the clinical coordinators involved 
in the study will meet and/or review study data. 
 
Investigators, study personnel, and the clinical coordinators involved in the study will meet weekly to discuss the study and 
address any issues or concerns at this time. These meetings are overseen by the Directors of Human Engineering 
Research Laboratories or their designees. 
 
3.0 
* Will this study use a Data Safety Monitoring Board or Data Monitoring committee? 
Yes 
No 
 
4.0 
* Will this study use a Medical Monitor? 
Yes 
No 
 
 
Costs and Payments 
1.0 
* Does this study have a budget?: 
Yes 
No 
If yes, please upload the current budget: 
VGS ARMS Budget.xls(0.01) 
 
2.0 
* Will patients receive payments for this study? 
Yes 
No 
If yes, please upload the financial letter of support (either from the Business Service line or the Veterans 
Health Foundation) or documentation waiving the requirement of a letter of support: 
Financial Letter of Support.pdf 
0.01 
3.0 
* Are you paying patients using the WePay system? 
no 
 
Costs 
 
1.0 
* Will subjects be required to pay for any services outside of the VHA that may be required as 
part of participating in this research study? 
Not applicable. 
 
Participant Payments 

ID: Pro00003276 
View: 14 References 
1.0 
* Please explain how the proposed payments are reasonable and commensurate with the 
expected contributions of the subject: 
Because the subjects will be spending about 6 hours in the lab, the study team feels that $150.00 (which is 
$25/hour) is both reasonable and commensurate for the activities involved with the research study. 
 
2.0 
* Please provide information on how the subject payments are fair and appropriate, and that 
they do not constitute (or appear to constitute) undue pressure or influence on the prospective 
research subjects to volunteer for, or to continue to participate in, the research study. In 
additional the payments do not constitute (or appear to constitute) coercion to participate in, or 
continue to participate in, the research study: 
Participants will be reimbursed for the time and effort they invest in participating in this study. The study 
time will be limited to 6 hours at most. $150 is similar on a per hour basis to how much a majority of other 
studies pay. The study activities are also simple in nature and of minimal risk, furthering the fact that $150 
for 6 hours or $25/hour is a fair payment. The participate is free to withdrawal from the study at any time 
and receive $25 for their participation. 
 
3.0 
* Specify the amount, form of payment and the specific disbursement schedule of payments: 
Subjects will be compensated $25/hour for their time and effort in completing the study. If they are 
determined not eligible for participating in the study during the pretest session, they will receive $25. 
Subjects will be compensated by the VA using Electronic Funds Transfer. 
 
4.0 
* Are the subjects being paid employees? 
no 
If yes, please describe how it will be in accordance with the SOP: 
 
References: 
1.0 
* Please provide a list of references (Multi-site protocols: You may reference the page numbers in the 
original protocol): 
1. Hubbard SL, Fitzgerald SG, Reker DM, Boninger ML, Cooper RA, Kazis LE. Demographic characteristics of 
veterans who received wheelchairs and scooters from Veterans Health Administration. J Rehabil Res Dev. 
2006; 43(7): 831-44. 
2. Schoenborn CA, Vickerie JL, Powell-Griner E. Health characteristics of adults 55 years of age and over: 
United States, 2000-2003. Adv Data. 2006; 370: 1-31. 
3. Broeks JG, Lankhorst GJ, Rumpling K, Prevo AJ. The long-term outcome of arm function after stroke: 
results of a follow-up study. Disabil Rehabil, 1999; 21(8):357–64. 
4. Simonsick EM, Kasper JD, Guralnik JM, Bandeen-Roche K, Ferrucci L, Hirsch R, et al. Severity of upper 
and lower extremity functional limitation: Scale development and validation with self-report and 
performance-based measures of physical function. Journals Gerontol B Psychol Sci Soc Sci. 2001; 
56(1):S10-9. 
5. Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004; 
21(10): 1371-83. 
6. Maheu V, Frappier J, Archambault PS, Routhier FF, Frappier J, Routhier FF. Evaluation of the JACO robotic 
arm: Clinico-economic study for powered wheelchair users with upper-extremity disabilities. In: 2011 IEEE 
International Conference on Rehabilitation Robotics; 2011. p. 1–5. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/22275600. 
7. Leaman J, La HM. A comprehensive review of smart wheelchairs: past, present, and future. IEEE 
Transactions on Human-Machine Systems. 2017; 47(4): 486-99. 

8. Wu YK, Liu HY, Kelleher A, Pearlman J, Ding D, Cooper RA. Power seat function usage and wheelchair 
discomfort for power wheelchair users. J Spinal Cord Med. 2017; 40(1):62–9 
9. Feinberg LF, Wolkwitz K, Goldstein C. Ahead of the curve: emerging trends and practices in family 
caregiver support. Natl Cent Caregiving. 2006. 
10. Atkins MS, Baumgarten JM, Yasuda YL, Adkins R, Waters RL, Leung P, et al. Mobile arm supports: 
evidence-based benefits and criteria for use. J Spinal Cord Med. 2008;31(4):388–93. 
11. Bryden A, Peljovich A, Hoyen H, Nemunaitis G, Kilgore K, Keith M. Surgical restoration of arm and hand 
function in people with tetraplegia. Top Spinal Cord Inj Rehabil. 2012; 18(1): 43-9. 
12. Kilgore KL, Hoyen HA, Bryden AM, Hart RL, Keith MW, Peckham PH. An Implanted upper-extremity 
neuroprosthesis using myoelectric control. J Hand Surg Am. 2008; 33(4): 539-50. 
13. Gorman PH, Wuolle KS, Peckham PH, Heydrick D. Patient selection for an upper extremity 
neuroprosthesis in tetraplegic individuals. Spinal Cord. 1997;35(9):569–73. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/9300960. 
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spinal cord injury. Physical Medicine and Rehabilitation Clinics of North America. 2014. 
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on current status, challenges and future directions. 2015 IEEE/SICE Int Symp Syst Integr SII 2015. 211–6. 
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wrist–hand orthosis for the remediation of upper extremity paresis and loss of function in chronic stroke. Mil 
Med. 2017;182(7):e1963–8. Available from: http://militarymedicine.amsus.org/doi/10.7205/MILMED-D-16- 
00399 
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assistive robotics to empower people with disabilities. IEEE Robot Autom Mag [Internet]. 2013; 20(1):30–9. 
Available from: https://www.willowgarage.com/sites/default/files/Chen_RFH_ram_2013.pdf 
18. Brose SW, Weber DJ, Salatin BA, Grindle GG, Wang H, Vazquez JJ, et al. The role of assistive robotics in 
the lives of persons with disability. Am J Phys Med Rehabil [Internet]. 2010; 89(6):509–21. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/20134305 
19. Jain A, Kemp CC. EL-E: An assistive mobile manipulator that autonomously fetches objects from flat 
surfaces. Auton Robots. 2010. 
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robotic butler. Auton Robots. 2009; 28(1):5–20. Available from: 
http://www.springerlink.com/index/10.1007/s10514-009-9160-9 
21. Routhier F, Archambault P, Cyr M, Maheu V, Lemay M, Gélinas I. Benefits of Jaco Robotic Arm on 
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23. Herlant L V, Holladay RM, Srinivasa SS. Assistive teleoperation of robot arms via automatic timeoptimal 

mode switching. Human-Robot Interact. 2016; Available from: 
http://www.ri.cmu.edu/pub_files/2016/3/mode_switching.pdf 
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25. Pulikottil TB, Caimmi M, Dangelo MG, Biffi E, Pellegrinelli S, Tosatti LM. A Voice control system for 
assistive robotic arms: preliminary usability tests on patients. In: Proceedings of the IEEE RAS and EMBS 
International Conference on Biomedical Robotics and Biomechatronics. 2018. 
26. Lebrasseur A, Lettre J, Routhier F, Archambault PS, Campeau-Lecours A. Assistive robotic arm: 
Evaluation of the performance of intelligent algorithms. Assist Technol. 2019; 
27. Park D, Hoshi Y, Mahajan HP, Rogers WA, Kemp CC. Toward active robot-assisted feeding with a 
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http://arxiv.org/abs/1904.03568. 
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2015 IEEE International Conference on Robotics and Automation (ICRA). IEEE; 2015. p. 4458–63. Available 
from: http://ieeexplore.ieee.org/lpdocs/epic03/wrapper.htm?arnumber=7139816 
29. Ivorra E, Ortega M, Catalán JM, Ezquerro S, Lledó LD, Garcia-Aracil N, et al. Intelligent multimodal 
framework for human assistive robotics based on computer vision algorithms. Sensors. 2018;18(8):1– 24. 
30. Ka HW, Chung C-S, Ding D, James K, Cooper R. Performance evaluation of 3D vision-based 
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https://www.tandfonline.com/doi/full/10.1080/17483107.2017.1299804 
31. Broad A, Arkin J, Ratliff N, Howard T, Argall B. Real-time natural language corrections for assistive 
robotic manipulators. Int J Rob Res. 2017;36(5-7). 
32. Hammel J, Hall K, Lees D, Leifer L, Van der Loos M, Perkash I, et al. Clinical evaluation of a desktop 
robotic assistant. J Rehabil Res Dev. 1989; 26(3):1–16. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/2754623 
33. Bach JR, Zeelenberg AP, Winter C. Wheelchair-mounted robot manipulators. Long term use by patients 
with Duchenne muscular dystrophy. Am J Phys Med Rehabil. 1990; 69(2):55–9. Available from: 
http://www.ncbi.nlm.nih.gov/pubmed/2331340 
34. Zhong M, Zhang Y, Yang X, Yao Y, Guo J, Wang Y, et al. Assistive grasping based on laser-point 
detection with application to wheelchair-mounted robotic arms. Sensors, 2019;19(2). Available from: 
https://www.mdpi.com/1424-8220/19/2/303. 
35. Kapusta A, Chitalia Y, Park D, Kemp CC. Collaboration between a robotic bed and a mobile manipulator 
may improve physical assistance for people with disabilities. IEEE ROMAN Workshop on Behabvior, 
Adaptation, and Learning for Assistive Robotics. 2016. 
36. Aronson RM. Semantic gaze labeling for human-robot shared manipulation. ACM Symposium on Eye 
Tracking Research and Applications. 2019. 
37. Admoni H, Srinivasa S. Predicting user intent through eye gaze for shared autonomy. AAAI Fall Symp 

Ser Shar Auton Res Pract. 2016;298–303. 
38. Kim D-J, Hazlett-Knudsen R, Culver-Godfrey H, Rucks G, Cunningham T, Portee D, et al. How autonomy 
impacts performance and satisfaction: results from a study with spinal cord injured subjects using an 
assistive robot. IEEE Trans Syst Man, Cybern - Part A Syst Humans. 2012; 42(1):2–14. Available from: 
http://ieeexplore.ieee.org/xpls/abs_all.jsp?arnumber=5941028 
39. Laffont I, Biard N, Chalubert G, Delahoche L, Marhic B, Boyer FC, et al. Evaluation of a graphic interface 
to control a robotic grasping arm: a multicenter study. Arch Phys Med Rehabil. 2009; 90(10):1740–8. 
Available from: http://www.ncbi.nlm.nih.gov/pubmed/19801065 
40. Allin S, Eckel E, Markham H, Brewer BR. Recent trends in the development and evaluation of assistive 
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66. Ekstrom RB, French JW, Harman HH, Dermen D. Manual for Kit of Factor Referenced Cognitive Tests. 
Princeton, NJ: Educational Testing Service; 1976. 
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evaluation for assistive robotic manipulators. Am J Phys Med Rehabil. 2016. Available from: 
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68. Hart S, Staveland L. Development of NASA-TLX (Task Load Index): results of empirical and theoretical 
research. Hum Ment Workload. 1988; 1(3):139–83. Available from: 
http://humanfactors.arc.nasa.gov/groups/TLX/downloads/NASA-TLXChapter.pdf 
 
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Study Funding Source 
 
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* Funding Source Name: 
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* Device Name: 
Kinova Gen3 Assistive Robotic Manipulator 
* Use of Device: 
Investigational Device Not Yet Approved for use 
Manufacturer: 
Kinova 

IDE Class: 
IDE Number(if Applicable): 
Risk Level Determined by Sponsor: Non-Significant Risk 
Kinova Gen3 Brochure(0.01) 
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Provide any other notes about how this device will be used or justification for lack of IDE number 
The Kinova Gen3 Assistive Robotic Manipulator is a device that was built for human-robot interaction with flexible 
functionalities to ensure better safety and 
performance in any research environment. It equips discrete 2D and 
3D sensors for vision-based applications and 7 DOF robotic arm for the daily object manipulation. The Kinova Gen3 
Assistive Robotic Manipulator is a commercially available robotic research system, which will be positioned on a 
commercial electric powered wheelchair to assist daily manipulation tasks. The Kinova Gen3 Assistive Robotic 
Manipulator will be used to object recognition and manipulation. The Kinova Gen3 Assistive Robotic Manipulator can 
be powered using the wheelchair batteries and wall outlet. The Kinova Gen3 Assistive Robotic Manipulator has three 
layers of safety. First is the mechanical layer, which includes soft cover of screws, smoothed edges and surfaces, and 
padding on connectors and power cables. In the unlikely event of a power failure, the arm is freely movable to 
reposition. The second layer is electronic, which includes self collision prevention, joint limits, hard force limits, hard 
speed limits, user initiated stops, and force compliance, which allows the robot to elastically bend in under certain 
loading conditions. Most importantly, the Kinova Gen3 Assistive Robotic Manipulator does not move quickly, providing 
humans time to react to the devices movements. In addition, the manipulator stops when the user releases the 
joystick or control interface. The third layer is the software layer, which allows for programming of constraint spaces 
including slow moving and keep-out zones. The software layer is unique to robotic technologies and has potential to 
detect unsafe situations before they lead to accidents. A significant risk device is defined as an investigational device 
that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a 
subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, 
safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, 
safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject. The Kinova Gen3 
Assistive Robotic Manipulator does not meet the definition of a significant risk device as it does not meet any of the 4 
criteria listed above. 
 
 
 
 
Is the investigator hold the IDE for this device? 
Yes 
No 
 
If yes please provide a basis for risk level. 
 
Address for each screening procedure, research intervention/interatction, and follow- 
up/monitoring procedure: 
* Research Activity: 
Interviews 
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Infrequent Risks: 
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Address for each screening procedure, research intervention/interatction, and follow- 
up/monitoring procedure: 
* Research Activity: 
Research activities 
Common Risks: 
Infrequent Risks: 
Video recording may incur risk of breach of confidentiality. 
Participants may experience frustration due to learning to use a new device or device malfunction. 
 
 
Other Risks: 
 
 
 
 
 
Address for each screening procedure, research intervention/interatction, and follow- 
up/monitoring procedure: 
* Research Activity: 
Questionnaires 
 
Common Risks: 
 
Infrequent Risks: 
Risk of breach of confidentiality. 
 
 
Other Risks: 
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