Home Study of an Advanced Upper Limb Prosthesis
Phase: NA
Conditions: Traumatic Amputation of Arm
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
Home Study of an Advanced Upper Limb Prosthesis 
 
 
IRB Approved Protocol 
06-16-2017 
 
 
NCT01551420 
 

Home Study of an Advanced Upper Limb Prosthesis 
Lead PI: Resnik 
1 
Version: 06-16-2017 
 
 
 
Background and Significance 
The number of patients with upper extremity amputation who are cared for in Veterans Administration facilities 
is increasing as a result of injuries sustained in recent conflicts. The majority of these amputees will separate 
from active duty and enroll in VA healthcare. Returning these amputees to full participation in work, leisure and 
social activities will be challenging given the limitations of commercially available upper limb prosthetics. 
Currently, the individuals with upper limb amputations must perform complex motions with control that is slow, 
cumbersome and unnatural. Furthermore, amputees have no direct sensory feedback with their prostheses 
and only receive feedback on the limb performance by watching or in some cases listening to the sounds 
generated by motors. 
 
Given these challenges, representatives of the VA and DARPA have called for more collaboration between the 
two entities in meeting the needs of individuals who have lost their arms and highlighted the need for additional 
research on upper extremity prosthetics. DARPA funded the development of the DEKA Prosthetic Arm which 
incorporates major technological advances such as flexible socket design, and innovative control features and 
software that together enable enhanced functionality that promises to surpass any currently available prosthetic 
device. 
 
The DEKA Gen 3 Arm 
There are three versions of the DEKA Arm: shoulder configuration (SC, also known as shoulder disarticulation 
(SD)); humeral configuration (HC also known as transhumeral (TH)) and radial configuration (RC also known 
as transradial (TR)).  Photographs and characteristics of the Gen 2 version are shown in the Figure 1.  All 
versions have the following common features: multiple configurable hand grips, simultaneous joint control, 
intuitive control schemes, control inputs flexibility, compliance and afferent feedback. DEKA has conducted 
engineering tests to characterize/verify performance and refined “strap-and-go” arm control methods. The 
DEKA design incorporates improved end point control, and has added and refined multiple alternative control 
methods. They have built and tested smaller haptic systems and built smaller Gen 2 tactors with separate, 
mountable electronics. They also have implemented a simple vibration tactor. 
 
Shoulder Configuration 
Humeral Configuration 
Radial Configuration 
 
 
 
Degrees of Freedom 
Total 
Powered 
15 (6 arm, 9 hand) 
10 (6 arm, 4 hand) 
13 (4 arm, 9 hand) 
8 (4 arm, 4 hand) 
11 (2 arm, 9 hand) 
6 (2 arm, 4 hand) 
Weight 
8.0 lbs 
5.6 lbs 
2.5 lbs 
Control 
Foot pads, Shoulder 
joystick, Shoulder 
bladders, EMG switch 
Foot pads, EMG switch 
Foot pads, EMG 
Pattern recognition 
Figure 1. Versions and Characteristics of the Gen 2 DEKA Arm 

Home Study of an Advanced Upper Limb Prosthesis 
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Figure 2. Schematic View of Full (Shoulder Configuration) Gen 3 Arm 
 
The Gen 3 Arm system (Figure 2) incorporates several new features and changes such as: a compound wrist 
that includes radial/ulnar deviation with extension/flexion, improved external battery and charger, improved 
tactor, changes in wireless communication protocol, improved grip strength and hand speed, changes in finger 
grip trajectory, hardware changes to wrist and shoulder joint design, changes to connectors and cables, 
refinement of EMG and IMU sensors, changes to the user notification system, and improvements to the 
prosthetist user interface. These updates do not change the FDA risk determination (i.e. it is considered to be 
the same prosthetic Arm system). The DEKA Gen 3 Arm began clinical studies in late Spring 2011. 
 
Significance of the study 
The proposed study builds on the VA’s ground-breaking example of a successful DARPA-VA research 
collaboration that will continue the VA’s tradition of funding innovations and advances in prosthetic technology. 
This VA led home study will demonstrate the VA’s committment to advance cutting-edge prosthetic technology. 
Information gleaned from this study will be critically important in moving the DEKA Arm closer to 
commercialization and successful dissemination and deployment within the VA system of healthcare. Analyses 
conducted in the proposed study will be used to identify amputees who are appropriate candidates for 
advanced prosthetic devices as well as those who are likely to be poor candidates. The study will assess 
usefulness and acceptability in a home environment.  Data from this study will help inform future VA  
Prosthetics and Sensory Aids clinical guidelines for prescription of advanced upper limb prosthetic technology. 
 
Specific Aims 
The DEKA Arm, developed through DARPA’s “Revolutionizing Prosthetics” Program, incorporates major 
technological advances such as active volume controlled socket design, and innovative control features and 
software that together enable enhanced functionality that promises to surpass any currently available 
prosthetic device. A Memorandum of Agreement between the VA and DARPA paved the way for a two year 
VA clinical trial to optimize the Gen 2 prototype DEKA Arm System. This study provided data to inform DEKA’s 
development of the Gen 3 prototype. Evaluation of the Gen 3 prototype is underway,. Although DEKA has 
conducted a limited number of take home studies of the Gen 2 device, the VA studies of the DEKA Arm to date 
have only been conducted in-lab, meaning that VA subjects have used the prosthesis only under supervised 
conditions and were not allowed to take the device home and integrate it into their daily use. Thus, key 
outcomes including the extent of use or adoption of the arm for activities at home and the impact of the 
advanced prosthetic device on subjects’ quality of life have not been previously examined. The next step in 
determining the usefulness and acceptability of this advanced prosthetic device is to conduct studies of its 
home usage. The overall objective of the proposed study is to examine the feasibility, acceptance and benefits 

Home Study of an Advanced Upper Limb Prosthesis 
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of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized 
during 3 months of home usage. The specific objectives of this quasi-experimental, time series study are to: 
 
1. Identify and describe upper limb amputees who would be appropriate candidates for home use of 
this advanced prosthesis, as well as those who would not be appropriate. 
All participating subjects will enroll in Part A of the study, which will involve supervised, in-laboratory training, as 
well as supervised community based outings. Based upon the findings from Part A, study staff will classify 
participants as appropriate or not appropriate for participation in Part B (the home usage portion of the study). 
This classification will be based upon a specified set of criteria established to determine potential for safe home 
usage, as well as the completion of all aspects of Part A study activities. Safe home use criteria will include 
elements such as skillfulness of prosthetic use, independence in daily device maintenance and storage, and 
safety awareness.  Final determination of appropriateness for home use will be made after a home visit is 
conducted to assess the appropriateness of the home environment. We will attempt to identify any factors 
(such as results of neuropsychological testing) that can be used to predict those subjects who are deemed as 
not appropriate candidates for home use. 
 
2. Compare the extent of use of the existing prosthesis to that of the DEKA Arm and quantify the impact 
of home use of the DEKA Arm on device satisfaction, performance of functional activities and the 
user’s quality of life. 
Subjects will be asked to maintain daily logs detailing usage of their current prostheses. Additionally, data logs 
will be generated in the DEKA Arm software. This data will be collected several weeks prior to in-lab training 
with the DEKA Arm.  Measures of existing prosthetic activity will be compared with those of home use of the 
DEKA Arm to determine the extent of adoption. 
 
3. Compare the outcomes of users of pattern recognition to the outcomes of users without.. 
We will use a time series design to examine changes in device satisfaction, performance of functional activities 
and quality of life throughout the study. 
 
4. Quantify the amount and type of technical support and repairs needed during the study, and 
estimate the number of home study days lost due to service/repair. 
We will gather data on technical support usage, including number and content of calls and email exchanges 
with DEKA support and number and type of repairs needed during the study. This information will be useful in 
estimating service needs for clinical deployment. 
 
This study will provide important information to help determine which amputees are appropriate candidates for 
this advanced prosthetic device, as well as provide data on usefulness and acceptability in a home 
environment.  Data from this study will help inform the development of clinical guidelines for prescription of 
advanced upper limb prosthetic technology.  Currently, VA Prosthetics and Sensory Aids has few, if any, 
clinical guidelines to inform prescription of advanced technologies, determine appropriate candidates or 
readiness for home use of prosthetic devices. 
 
Preliminary Studies: VA STUDY TO OPTIMIZE THE DEKA ARM 
Overview and Purpose 
Dr. Resnik is the Principal Investigator of the VA multisite studies to optimize the DEKA Arm which began in 
2008. The overall purposes of this study are to 1) determine the feasibility of the deployment of the DEKA Arm 
by clinicians in the rehabilitation community; and 2) optimize the DEKA Arm System to best suit VA patient 
needs. 
 
Study Design 
This study was an iterative usability and optimization study employing a multiple case study design using a 
mixed-methodology approach. Concurrent quantitative metrics and qualitative data are collected to provide 
richer, more valid, and more reliable findings than a design based on either the qualitative or the quantitative 

Home Study of an Advanced Upper Limb Prosthesis 
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method alone.1 This study involves 2 phases: the first (which is completed) tested the Gen 2 Arm; and the 
second phase (which began in spring 2011) is testing the Gen 3 Arm. Each subject’s involvement requires 
approximately 21 visits; however, subjects who use the powered shoulder may have an additional 6 visits. 
Study activities include 2 visits for testing with current prosthesis, 3-7 visits for prosthetic fitting and controls 
set-up, 15 visits (2 hours each) for training, and 3-4 testing visits using the DEKA Arm. 
 
Research Sites 
The VA Study to Optimize the DEKA Arm is coordinated by the Providence VA Medical Center (PVAMC) team 
led by Dr. Resnik and includes four data collection sites: 3 VA Medical Centers: the VA NYHHS (Manhattan), 
the James Haley VA Medical Center (Tampa), the Long Beach VA (Long Beach) and one DoD site, the Center 
for the Intrepid (CFI) at Brooke Army Medical Center.  The research team at each data collection site includes 
the Principal Investigator (who may be the study physician or a therapist), 2 Prosthetists, 2 Occupational 
Therapists, a Research Assistant and the study Physician.  Sites are linked through secure videoconferencing, 
dedicated for study activities. Study sessions are videotaped and recorded to a secure, dedicated content 
server. 
 
Data Collection 
Data is collected from three sources: subjects, prosthetists, and therapists. Standardized outcome measures 
are used to assess dexterity, functional performance, and prosthetic satisfaction while the use of qualitative 
methods including interviews, videotaped observations, and open-ended surveys are used to understand 
participants’ perspectives on the use of the DEKA Arm. Additionally; all subjects complete a brief battery of 
widely-used, standardized, clinical neuropsychological tests. 
 
Data Analysis 
Both qualitative and quantitative analyses for Phase I (Gen 2) are underway. While the bulk of study analyses 
to date have focused on providing recommendations to DEKA for improving the design of the Gen 3 Arm, we 
have conducted descriptive analyses, and preliminary analyses of differences between dexterity, function and 
satisfaction at Visit 1 with current prostheses and after training with the DEKA Arm.  Additionally, we conducted 
preliminary analyses of neuropsychological tests to quantify the relationship between test scores and clinician 
judgment regarding whether or not subjects were appropriate candidates for home use of the Arm. 
 
Sample 
In the Gen 2 portion of the study, we screened 56 potential research subjects, 26 of whom were fit with the 
Gen 2 DEKA 
Arm. The 
characteristics of 
the twenty six 
participants were 
tested with the 
Gen 2 DEKA 
Arm are shown 
below in Table 1. 
We began 
testing of the 
Gen 3 Arm in 
spring 2011 and 
based upon our 
CRADA with 
DEKA plan to 
include between 
8 and 10 
subjects. Our 
Table 1. Characteristics of Study Participants Fit with the Gen 2 Arm 
Transradial 
(N=8) 
Transhumeral 
(N=8) 
Powered Shoulder 
(N=10) 
All 
(N=26) 
Age  mean (sd) 
Minimum, Maximum 
53.13 (19.92) 
21, 82 
36.38 (13.78) 
19, 62 
45.7 (14.21) 
22, 62 
45.12 (16.8) 
19, 82 
Gender 
Male 
8 
6 
8 
22 
Female 
0 
2 
2 
4 
Status 
Veteran 
6 
3 
4 
13 
Active Duty 
1 
2 
2 
5 
Non-Veteran 
1 
3 
4 
8 
Prosthetic User 
Yes (full & part time) 
8 
6 
9 
23 
No 
0 
2 
1 
3 

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experience to date suggests that there is a robust and motivated pool of potential subjects who would be 
willing to participate in the proposed study. 
 
Results 
Dexterity 
Although the study was not designed to test the effectiveness of the DEKA Arm, we did collect 
data on use of the existing prosthesis which can be contrasted with use of the DEKA Arm. 
Results of the dexterity testing are shown 
in Table 2. Preliminary analyses suggest 
that subjects using the DEKA Arm had 
equivalent dexterity as evidenced by 5/6 
scores of the Jebsen-Taylor Hand 
Function Test (JTHFT)2 at the end of the 
study, and superior dexterity as measured 
by 2/6 Jebsen tests. However, 
performance with the current prosthesis 
surpassed that of the DEKA Arm in 
number of blocks moved in the  Modified 
Box and Block Test of Manual Dexterity.3, 
4 These results should be interpreted 
cautiously due to the small number of 
subjects in the study, as well as the 
variability in baseline proficiency with 
current prosthesis, type of device, and 
years of experience with usage. 
 
Function   
Subjects self-reported their function using  a patient-specific outcome measure, the Patient Specific Functional 
Scale (PSFS),5   and the Upper Extremity Functional Scale  (UEFS) from the Orthotics and Prosthetics Users 
Survey (OPUS). 6, 7 Results of 
preliminary analyses (Table 3) 
reveal better or equivalent self- 
reported functional scores 
using the DEKA Arm as 
compared to the existing 
prosthesis.  Of note, the 
number of daily activity items 
performed using the prosthesis 
increased from 9 using the 
current prosthesis to 17 (out of 
23 items) using the DEKA Arm. 
 
At the end of the study subjects were asked to list up to five new activities they were able to perform using the 
DEKA Arm that they had not been able to perform with their current prostheses. Among 22 subjects who used 
prostheses prior to the study, 21 gave examples of new activities performed. The most frequently mentioned 
types of new functional activities were self-care and everyday household/office tasks. 
 
Satisfaction 
Satisfaction with the current prosthesis and the DEKA Arm were comparable as measured by 
Table 2.   Dexterity with Current Prosthesis and 
DEKA Arm 
Existing 
Prosthesis 
DEKA Arm 
P 
Mean(sd) 
Mean(sd) 
Box and Block 
14.7 (13.0) 
8.6 (5.8) 
.05 
Jebsen Number of Items 
Jebsen Writing 
17.3 (1.9) 
20.9 (.87) 
.10 
Jebsen Page turning 
3.3 (2.2) 
3.5 (1.6) 
.65 
Jebsen Small objects 
3.9 (2.4) 
4.5 (1.8) 
.37 
Jebsen Checkers 
3.0 (1.6) 
2.7 (1.4) 
.68 
Jebsen Eating 
3.4 (2.3) 
3.6 (2.2) 
.71 
Jebsen Light cans 
4.0 (1.8) 
4.9 (2.9) 
.02 
Jebsen Heavy cans 
4.1 (1.8) 
4.9 (2.1) 
.03 
 
Table 3.  Self-Reported Function with Current Prosthesis and DEKA 
Arm 
 
Existing 
Prosthesis 
DEKA Arm 
P 
 
Mean(sd) 
Mean(sd) 
PSFS (0-10) 
3.1 (1.8) 
5.6 (2.1) 
.00 
UEFS (1-5) 
2.1 (0.72) 
2.1 (0.50) 
.72 
UEFS (N items with prosthesis) 
9.4 (6.3) 
17.3 (6.6) 
.00 

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the Trinity Amputations and Prosthetics Experience Scale (TAPES) (Table 4). 8   However, TAPES scores 
alone do not capture the overall positive view of the DEKA Arm that was observed in the majority of subjects. 
Nineteen out of 25 (76%) subjects 
who completed end of study 
questionnaires indicated that they 
wanted to receive a DEKA Arm in the 
future. Many spoke about the 
potential for increased function and 
quality of life saying it “will make everyday activities better”, “would open up a whole new world of 
independence and quality of life”, and “it would make me feel whole again.” Examples of positive feedback 
from subjects are provided below: 
 
My impression of the Arm is that it is very useful in performing your activities of daily living. Pretty 
much all your everyday tasks that will require the use of very fine motor  skills which someone who 
doesn’t have arms at all would find very helpful. So it’s something that would open up a whole new 
world for some individual who’s never had  an arm or who’s lost an arm. -Subject with bilateral SD 
amputation 
Gives me hope for the future, gives me a reason to believe I could work again with the  use of two 
arms.  -Subject with TH amputation 
The DEKA Arm to me it’s sort of a miracle type of prosthesis -Subject with TR amputation 
 
Despite the positive responses of participating subjects, 21/25 (84%) did express one or more concerns about 
using the DEKA Arm at home. The most frequent concern related to durability and repair. Other common 
areas of concern were about the weight of the system, waterproofing, and independent donning and doffing. 
 
Appropriateness for Home Use 
Although the purpose of this study was not to determine readiness for home usage, we were interested in 
assessing who might be appropriate candidates for future (i.e. home usage of the DEKA Arm). At the end of 
the study we classified subjects as poor or questionable candidates for home use or good candidates for home 
use, based upon the clinical staff comments and observations of subject performance on video. We classified 
subjects as good users who we believed would be appropriate for home usage. We classified 2 users as poor 
candidates, and 3 users as questionable candidates. Preliminary evaluation of neuropsychological tests 
(conducted on 22/26 subjects) revealed that subjects classified as poor/questionable users had lower scores 
(P=.004) on time to complete an oral version of the Trail Making Test Part B , a test of cognitive set-switching 
involving alphanumeric sequencing.9   Successful users performed the task significantly faster than 
questionable/unsuccessful users with no difference in error rate. The groups did not differ significantly on any 
other test in our battery including measures of attention, processing speed, language, and memory. Based on 
these findings, the neuropsychological test battery for the proposed study will emphasize cognitive set- 
switching using the same battery used in our pilot study with additional switching tasks and other executive 
measures. 
 
Table 5. Trail Making B Test Results for Poor/Questionable Users and Good Users 
Poor/Questionable User 
Good Users 
P 
Mean (sd) 
Mean (sd) 
Trail Making B time to complete 
69.7 (26.9) 
35.3 (19.8) 
0.004 
Trail Making B Errors 
2.4 (2.5) 
1.6 (1.7) 
0.177 
 
Need for future research 
The VA Study to Optimize the DEKA Arm was conducted entirely in-laboratory, meaning that all usage of the 
DEKA Arm was supervised by study staff and subjects did not take the arm home, nor were any subjects left 
Table 4.   Satisfaction with Current Prosthesis and DEKA Arm 
Existing Prosthesis 
DEKA Arm 
P 
Mean(sd) 
Mean(sd) 
TAPES 
3.0 (1.4) 
3.3 (.81) 
.39 

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alone while wearing the arm.  Although our training protocol involves performance of many functional activities 
such as cooking, simulated housekeeping and eating, subjects did not have the opportunity to utilize the arm in 
their own environment, or without supervision. Thus, the study was unable to gather data on the impact of 
DEKA Arm usage on quality of life. Nor was this study able to glean information on adoption of the arm in home 
use and/or compare data on wear time of the DEKA Arm in the home environment. The proposed study       
will provide the opportunity to examine these critical areas of prosthetic use. 
 
Research Design and Methods 
Design 
This  proposed study will employ a quasi-experimental, time series design to provide the data needed to 
compare usage of existing prosthesis to the of the DEKA Arm, and assess the acceptance and benefits of 
home usage. This study will involve two parts. Part A will involve in-laboratory training and supervised 
community based outings using the DEKA Arm. A selection of Part A participants will be invited to participate 
in Part B testing which will involve a 3 month trial of home use with biweekly study visits. 
 
Acquisition of DEKA Arms 
Gen 2 and Gen 3 Arms for the VA Study to Optimize the DEKA Arm were provided under the terms of 
CRADAs between each VA Medical Center and DEKA. These activities were coverable under the terms of the 
DEKA-DARPA contract to develop the advanced prosthetic arms. Because the DARPA contract is ending, a 
new mechanism for obtaining the DEKA Arms will be utilized. The PVAMC will contract with DEKA directly to 
purchase arms for this study. Negotiations with DEKA are underway and this multi-year contract is expected to 
be executed by 10/1/11. 
Sample 
Part A: We expect that we may need to enroll up to 100 amputees across all sites in order to yield complete 
Part A data on 40 subjects. This is due to anticipated screen failures (estimated at 20%) and the likelihood that 
some 20% of subjects (based upon prior study experience) who do meet eligibility criteria will not be able to 
participate in all research activities. Additionally, we will purposefully sample subjects to insure that we have an 
even distribution of subjects at each level of DEKA Arm fit during Part B (10 SD, 10 TH, 10 TR). 
 
Note: Subjects who have completed study participation may be invited, at the request of the Principal 
Investigator, to participate a second time in order to be set up with and evaluate an alternative controls scheme 
than what they had used previously.  These subjects will need to be consented again and complete all study 
activities including screening. 
 
Part B: We expect that up to 20% of Part A participants may not be considered appropriate for home study 
usage. Thus, we expect that up to 36 participants who have completed Part A of the study will be invited to 
participate in the home study portion (Part B) of the study. We will purposefully select subjects who have 
completed Part A and who are judged to be appropriate candidates for home use (see Part A Preliminary 
Determination of Appropriateness for Unsupervised, Home Device Use). Our goal is to have complete data on 
up to 30 subjects with the Gen 3 DEKA Arm. We plan to include approximately10 subjects fit at each of the 3 
levels of amputation (SD, TH, TR). We estimate that 20% (or 4 subjects) may terminate the study early. 
 
For both parts of the study, an estimated 80% of subjects will be veterans enrolled in the VHA or DOD 
healthcare systems. Approximately 20% of subjects may be non-veterans whose participation may be needed 
to meet sampling goals for amputees with higher levels of limb loss, and to insure the inclusion of female 
amputees. Subjects who have participated in the VA Study to Optimize the DEKA Arm or the VANYHHS pilot 
study to optimize the DEKA Arm will be eligible to participate in this study. 
Inclusion Criteria (Parts A and B): 
 
All subjects must be at least 18 years old and have single or bilateral upper limb amputation. 
 
Subjects must be able to understand the requirements of the study and sign an Informed Consent Form 

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and HIPAA Authorization Form. 
 
Subjects will include those who are current users of any type of prosthetic device (body powered, 
electric or hybrid), non-users of devices who have been previously fit with a device, but have chosen 
not to wear it, as well as new users of devices. 
 
To participate in the study all subjects must  have active control over one or both ankles, OR have an 
appropriate number of myoelectric and/or other control sites (as determined by the Principal 
Investigator in conjunction with the research team) to allow adequate prosthetic controls configuration. 
Inclusion Criteria Part B only: 
 
Completion of all Part A study activities. 
 
Meets all criteria for Preliminary Determination of Appropriateness for Unsupervised, Home Device Use 
(see Preliminary Determination of Appropriateness for Unsupervised, Home Device Use). 
Exclusion Criteria (Parts A and B): 
 
Amputees with elbow disarticulation, wrist disarticulation and partial hand amputations will be excluded.* 
 
Amputees will be excluded if the length of their residual limb would prohibit socket fitting, as determined 
by the study prosthetist. 
 
Persons with significant uncorrectable visual deficits that would impair the ability to see the prosthesis 
and those who have major communication or neurocognitive deficits will be excluded. 
 
Persons with skin conditions such as burns or poor skin coverage as well as those with severe 
contractures that prevented prior prosthetic wear will be excluded. 
 
Persons with electrically controlled medical devices including pacemakers, and implanted defibrillators 
will be excluded. 
 
Persons with neuropathy, uncontrolled diabetes, who are receiving dialysis, have insensate feet, severe 
phantom pain or a history of skin ulcers or any other significant comorbidity which would interfere with 
the study will be excluded. 
 
Those with severe circulatory problems including peripheral vascular disease and pitting edema will be 
excluded. 
 
Persons with cognitive deficits or mental health problems that would limit their ability to participate fully 
in the study protocol will be excluded. 
 
Women who are pregnant or who plan to become pregnant in the near future will also be excluded. 
 
We will exclude those amputees who work for prosthetic companies that may be considered 
competitors for the DEKA Arm technology in the future. 
 
Persons taking medication which poses a risk for operation of heavy equipment will be excluded. 
  
 After 7/1/16, all amputees with shoulder disarticulation or forequarter amputation will be excluded. 
 
Impaired Decision-making Capacity: 
In cases where decision-making capacity of a potential research subject is questioned, the modified Dysken 
tool will be used as an assessment tool to evaluate capacity to provide informed consent.  Subjects must 
answer at least 70% of questions on the screening tool correctly in order to be considered as having sufficient 
understanding of the study to provide informed consent. 
 
Sampling strategy 
Subjects will be purposefully sampled to include participants at each of three levels: transradial, transhumeral, 
shoulder disarticulation/forequarter level. Our goal is to have a heterogeneous sample with a mix of unilateral 
and bilateral amputees, regular prosthetic users as well as non-users. We hope to include female amputees at 
each level, if at all possible. We believe that this projected sample size will be adequate to achieve our goals. 
Previous studies show that 80% of major usability problems (as judged by need for technical support and 
repair) can be detected within the first 5 cases.10 The FDA suggests that data from about 10 individuals from a 
homogenous population is typically sufficient to discover most types of usability concerns.11 However, with 
greater heterogeneity, a greater sample size may be desirable.11 Thus, experts in usability testing recommend 

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the number of subjects should not be fixed apriori, but rather continue, if possible, until no issues are 
uncovered. 10 Given this, our goal is to sample between 5 and 10 subjects from each amputation level. 
 
 Subject Recruitment   
A number of methods will be utilized to recruit subjects into the study. First, clinical staff from study sites will 
inform potentially eligible subjects about the study and invite them to participate. Second, email notifications 
regarding the study will be sent periodically to national list-servs for prosthetic and rehabilitation staff. Third, 
approved flyers and brochures will be distributed at VA/DoD medical centers, private prosthetic treatment 
centers, and other locations that upper limb amputees might frequent. Fourth, we will distribute press-releases 
to news groups as well as consumer organizations including the Amputee Coalition of America, Wounded 
Warriors, and the Disabled Veterans of America. Thus, potential subjects who show an interest in participating 
can learn more about the study from this informational material.  Finally, subjects who participated in earlier VA 
studies of the DEKA Arm, who consented to be contacted in the future may be informed about the new study 
and invited to participate. 
 
Research Sites 
The proposed study will be coordinated by Dr. Linda Resnik at the Providence VA Medical Center (PVAMC). 
Dr. Resnik is the Principal Investigator for the multisite VA Study to Optimize the DEKA Arm. As such, her team 
has acquired the expertise and experience to lead the proposed study. Data collection will take place at 3 sites, 
including 2 VA Medical Centers and 1 DoD site. Given that upper limb amputees comprise less than 3%         
of the amputee population and few VA/DoD prosthetists have extensive experience in this area, we will utilize 
sites who participated in the VA Study to Optimize the DEKA Arm. If additional funding becomes available, 
there is the possibility that we may include one or two additional research sites to achieve our subject 
recruitment goals. New sites will be required to have certified prosthetists who are very experienced with upper 
extremity prosthetic fitting and fabrication, fabrication facilities, and the availability of an experienced therapist 
to lead the training. We expect to begin Year 1 of the study with the following 3 experienced sites: VANYHHS 
(Manhattan), James Haley VA (Tampa) and Center for the Intrepid (CFI) at Brooke Army Medical Center (San 
Antonio.) After 7/1/2016, the James Haley VA (Tampa) will be the only site actively recruiting participants. 
 
Training and Supervision of Study Staff at each Site 
Proper fit of the prosthetic socket requires a great deal of advanced clinical decision-making and prosthetic 
fabrication skill. Proper socket fit is an absolute requirement for successful set-up and use of the DEKA Arm 
system. Because the fitting and fabrication of the DEKA Arm’s dynamic socket may be new to study 
prosthetists, we plan to provide training, supervision and support for prosthetists to increase the chances of a 
successful result. Before a new site begins data collection, the site prosthetist will participate in hands-on 
training to observe fit and fabrication of the dynamic socket and set-up of a DEKA Arm system.  Following that 
observation, each prosthetist will fit the first subject of each level of amputation under the supervision of a more 
experienced study prosthetist. Additional subjects (beyond the initial subject at each amputation level) will be fit 
under supervision as needed, based on the complexity of the case and prosthetist judgment. Throughout the 
remaining study data collection period, the site prosthetist will consult with the study’s lead prosthetist and/or 
prosthetic consultant/s and with DEKA engineers by telephone, video consultation and in-person as needed for 
troubleshooting and technical advice. 
 
Prior to initiation of study activities at each site, the study therapist (who will be either a PT or an OT), will be 
trained in the study training and testing procedures by Dr. Resnik in conjunction with experienced therapists 
(who participated in VA Study to Optimize the DEKA Arm). Dr. Resnik and/or the study Project Manager will 
oversee implementation of training and testing protocols. Video and teleconferences between the study 
personnel will be held at regularly scheduled intervals (e.g. monthly) and as needed for monitoring of fidelity to 
the study protocol and troubleshooting. 
 
Overview of Study Procedures 
Part A – Current Device Usage Monitoring and Supervised Training 

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Version: 06-16-2017 
 
 
 
Each subject’s involvement in Part A of the study will require 2 weeks of home device use monitoring with their 
existing prosthesis and between 18-34 supervised visits at the site. The majority of visits will be for training 
with the DEKA Arm. In addition, some subjects may require an additional 3-5 visits beyond the estimated 18- 
34 visits because of a need to modify their prosthetic socket or reconfigure their controls. 
 
Part A study procedures may be broken down into two components: 1) baseline testing and current device 
usage monitoring and 2) fitting/set-up and 3) training, in order to allow subjects to fit the study activities into 
their schedule. The estimated timeline of participation for Part A study activities is shown in the Gannt chart 
below. 
 
Estimated Timeline of Study Activities: Part A 
(Weeks) 
Activities 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Consent Process 
Medical Screening 
Baseline Data Collection 
Current device usage monitoring 
Pre-Prosthetic Training 
Prosthetic fit and set up 
Training sessions (average 3x/week) 
Preliminary Determination of Appropriateness for Home Use 
 
Part B - Take Home Portion of the Study 
Subjects who complete all Part A study activities and who are determined to be appropriate candidates for 
unsupervised home device use will be invited to participate in the Take Home Portion of the study (Part B). 
Prior to initiation of any take home activities, the study staff will conduct an assessment of the subject’s home 
environment to make a final determination of appropriateness of unsupervised, take home usage. Once 
cleared for home use, Part B, subjects will return to the sites on a biweekly basis for study visits and will be 
asked to maintain daily usage logs between visits.  At the conclusion of Part B subjects will have a final 
session of data collection. It is estimated that Part B participation will last a minimum of 13 weeks. This 
timeline, shown in the Gannt chart below may be extended in the event that the arm is broken and requires 
repair. If this should occur, and the subject agrees, the length of the home study time will be extended to 
adjust for the number of days lost. 
 
Estimated Timeline of Study Activities: Part B 
(Weeks) 
Activities 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
Consent for Part B 
Home Visit/Final Determination of Appropriateness 
Begin take home activities 
Daily Usage Logs 

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Biweekly study visits 
Final data collection session 
 
Part A Procedures  
Part A - Visit 1 
Consent process 
After initial telephone screening to assess eligibility criteria, each potential subject will be scheduled for an 
in- person assessment which will be held in a private area. Before the assessment begins, the site PI, 
research assistant, or prosthetist will explain the study protocol. Subjects will be asked to make a 
commitment to be available for all study activities. Individuals will be given adequate time to review and 
comprehend all information about the study before agreeing to take part, minimizing the possibility of 
coercion and undue influence.  
 
Please note: (1) subjects who enrolled in the Gen 2 phase of the study and are returning for the Gen 3 
phase of testing will be given a new subject number and will complete all study visits. (2) Subjects who 
enrolled in the VA Study to Optimize the DEKA Arm and / or the Home Study of An Advanced Upper Limb 
Prosthesis, who are returning to participate, be set up, and evaluated with an alternative controls scheme 
will be given a new subject number. 
 
Medical screening 
The site physician will conduct an in-person medical screening to confirm that inclusion/exclusion criteria are 
met. If the subject is found to meet the inclusion/exclusion criteria, is willing to participate, provides written 
consent, and is considered a viable candidate for pattern recognition (Coapt) use -if enrolling in to be 
evaluated with this alternative controls scheme- they will then be enrolled in the study. After enrollment, the 
study staff will provide detailed teaching and orientation material about the DEKA Arm system. Subjects will 
be scheduled for prosthetic fitting and set- up as scheduling and Arm availability permits. The remainder of 
activities for Visit 1 may be completed in the same session, or if scheduling requires, may be completed in a 
separate session. 
 
Collection of baseline data 
After enrollment, the prosthetist and therapist will collect baseline data on current prosthetic use (if any), 
prosthetic componentry, history of falls, and study measures. Diagnostic information regarding traumatic brain 
injury (TBI) and/or history of head injury will be recorded. Subjects will complete a brief neuropsychological 
screening exam. Baseline self-report and functional performance and quality of life testing will be conducted 
using the subject’s usual prosthetic device. (See Standardized Outcome Measures section). If the subject 
does not have a prosthetic limb, all applicable baseline testing will be performed without a device. 
 
Pre-prosthetic Training 
The study therapist will evaluate the subjects’ strength and ROM and prescribe a home exercise program 
to address any impairment. In addition, all appropriate subjects will be instructed in a home-based rotator 
cuff strengthening program to prevent excessive muscle soreness due to use of the DEKA Arm. 
 
Part A - Visit 2 
Baseline Retesting 
This visit will take place within 1 week of Visit 1. It will involve repeat administration of the self-report and 
functional performance testing administered during Visit 1. This information will be used to help us to 
determine the stability of the baseline test scores. 
 
Part A - Home Usage Monitoring 
    Subjects will be asked to maintain daily logs detailing usage of their current prosthesis over a period of two     

Home Study of an Advanced Upper Limb Prosthesis 
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Version: 06-16-2017 
 
 
 weeks. Additionally, subjects may be asked to wear an activity monitor for prosthetic use (the exact device  
 would be determined through pilot work.) This data will be collected prior to initiation of in-lab training with the  
 DEKA Arm. These measures of existing prosthetic activity will be compared with those of home use of DEKA  
 Arm to determine the extent of adoption.  Subjects who fail to complete the home use monitoring portion of the  
 study may be offered a second chance to complete the at-home log in a new two week time period.  Subjects   
 will be re-instructed on the use of the diary. Those who fail to complete study logs a second time will be  
  terminated from the study and will not be fit with a DEKA Arm. Non-prosthetic users will be exempted from this   
 requirement. 
 
Part A – Visits 3-8 
Fabrication of the prosthetic socket and set-up of prosthetic controls 
After baseline data collection (Visits 1 and 2) are completed, the prosthetist will begin fitting a custom socket 
and setting up the system controls. Subjects will have their prosthetic fitting, fabrication and systems set-up 
done at the participating VA site where they were screened. In some cases, the study lead prosthetist may 
travel to the participating site to provide direct supervision during the fitting and set-up. For all subjects, video 
and telephone conferencing with the study’s lead prosthetist, prosthetic consultant and DEKA engineers will 
take place as needed to troubleshoot concerns about socket fit and fabrication and controls set-up. All 
videoconferencing will take place using secure VA video equipment hosted and maintained by VA OI&T. We 
recognize that there is the possibility that a satisfactory check socket will not be able to be fabricated without 
direct supervision despite video or in-person prosthetic consultation. Because, testing and training activities 
with the DEKA Arm cannot commence without a satisfactory socket fit, if this should occur, then study activities 
may be delayed until a supervisory visit from the study prosthetic team can be arranged. 
 
We expect that the process of socket fabrication and determination of control set-up will take up to 6 sessions 
which last from 60 minutes to four hours each depending upon the complexity of the case. However, if the 
prosthetist agrees and the subject consents and their schedules allow, the duration of visits will be extended 
beyond four hours to accommodate patient preferences. We expect that each subject will require 1-6 check 
sockets prior to fabrication of the definitive socket. 
 
During prosthetic fit and set-up visits the subject will be familiarized with the arm controls using the Virtual 
Reality Environment (VRE).The VRE is an interactive computer software program which allows the subject to 
practice controlling the components of the arm without wearing the prosthetic limb.  Subjects using the RC and 
HC arms will have between 30 minutes and 2 hours of VRE time. The time allotted to VRE training for RC and 
HC will be determined, by the site therapist. Subjects using the SC arm will receive 4 hours of VRE training. 
 
During fitting and VRE activities, subjects will be provided with regular breaks as needed. Long prosthetic  
fitting sessions would involve substantial “down time” when the subject is resting or may be doing the VRE 
training and the socket is being fabricated in the laboratory. During fitting, the subject will have multiple 
standard impressions taken of their residual limb and torso using a plaster bandage method.  A stockinet and a 
barrier will be placed over the subject’s skin.Clothes will be covered to minimize the possibility of staining by 
the plaster. The impressions will be used to fabricate an appropriate socket with a harness as needed. 
Measurements of soft tissue compliance or stiffness at multiple locations on the residual limb and torso will be 
taken. 
 
The subject will be offered a variety of control options and the final decision as to the control scheme will be a 
collaborative decision-making process between the subject and the prosthetist. Subjects enrolling in the study  
phase evaluating use of the DEKA Arm with pattern recognition (Coapt) control, are required to use this control 
scheme as part of their control option. Whenever possible, the occupational therapist will be present during the 
systems controls set-up process so as to provide additional input into the decision-making process. Prosthetic 
controls may include surface EMG electrodes and combine the use of touch pads, switches, cables, inertial 
measurement units (IMUs) and other input devices that track or sense movements, such as foot pads, as well 
as tactors that provide mechanical stimulation to the skin surface related to activity or contact pressure. 
  Special Note: The Rivermead Extended Activities Index (REAI) may be completed during 2 consecutive visits   

Home Study of an Advanced Upper Limb Prosthesis 
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Version: 06-16-2017 
 
 
 between Visits 1 and 4. Administration must take place between 1 day and 1 week apart. Repeat    
 administration of this instrument will be used to help us to determine the stability of the instrument. 
 
Part A - Training Visits 
Once prosthetic fit, set-up and necessary VRE training is complete, subjects will be trained in the use of the 
   DEKA Arm by the study therapist.  Each subject will participate in an average of 18 training sessions. The    
 actual number of training sessions may vary from a minimum of 5 for TR amputees to a high of 25 for    
 amputees using the powered shoulder. The exact number of 2-hour training visits will be determined by the  
 site therapist based upon the speed of the subject’s acquisition of skills and knowledge needed to use the arm  
 appropriately and safely. We expect that subjects who have used the DEKA Arm in prior VA studies will   
 already be acquainted with the basic functions and controls of the arm and thus will require fewer visits, and  
 subjects who are new to the DEKA Arm as well as those who are powered shoulder users will require more  
 visits. We will cap the number of training visits at 20 (40 hours of training) for TR/TH users and 25 visits (50  
 hours of training) for SD users. 
 
Training session visits will last a minimum of 2 hours and could last as long as 4 hours (time estimate includes 
time for donning and doffing the arm, regular breaks, adjusting the system controls and handling other 
technical matters). If study staff encounter extensive technical difficulties, a session may be extended to 
accommodate teleconferences to troubleshoot and resolve the technical problems.  Subjects will be able to 
return on another day to complete the session if they are not able to stay for the duration of this time.  Five 
minute rest breaks will be provided every 20-30 minutes. Training activities will include: strengthening and 
ROM, a review of control sites, repetition of various drills to reinforce the patterns required for prosthetic 
utilization and a review of “new” prosthetic terminology relating to the DEKA Arm. Prosthetic use training will 
begin with reinforcement of prosthetic control patterns of motions, proceed to simple grasp and release 
activities, performance of patient requested activities, and  progress to more complex utilization of the 
prosthesis in unilateral and bilateral tasks, and ultimately lead  to supervised community based outings. 
 
Part A - Advanced Training Visits 
A minimum of 3 community outings will be conducted towards the end of the training visits. The purpose of 
these outings is to allow the subject to experience using the DEKA Arm in a public setting; the environment 
may be noisy or distracting. These outings will be scheduled when the therapist considers the subject adept 
enough to utilize the arm in a public setting with only minimal coaching and supervision. Key supervised 
outings will include at least one of each of the following types of activities: 1) eating a meal in public, such as at 
the cafeteria or a local restaurant, 2) riding in a car (as a passenger) or on some form of public transportation, 
3) shopping - entering a store, selecting and carrying purchases and paying for items. 
 
Part A - Testing Visits 
All subjects will repeat the baseline battery of tests after the completion of the initial 5 visits of training, and 
again after training is deemed complete. The plan for data collection at these visits is shown in Table 6. At the 
end of study testing session subjects will be asked to provide information about their impressions of the arm, 
the socket, their training experience, readiness for home usage as well as history of falls during the previous 
month. 
 
Part A - Preliminary Determination of Appropriateness for Unsupervised, Home Device Use 
Determination of appropriateness for unsupervised, home device use will be made by the therapist when the 
therapist thinks that the subject has mastered the knowledge and skills necessary for appropriate home usage, 
or after completion of the maximally allowable number of study training visits.  Therapists will utilize criteria 
relating to skillfulness of prosthetic use, independence in daily device maintenance and storage and safety 
awareness. (See Appendix 3:  DEKA Arm Do’s and Don’ts and Appendix 4: Assessment of Skill and Safety in 
Device Operation.) 
 
Part B Procedures 
Part B - Selection and Consent for Home Study 
  Subjects who complete all Part A study activities and who are determined to be appropriate for unsupervised    

Home Study of an Advanced Upper Limb Prosthesis 
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Version: 06-16-2017 
 
 
 home device use will be invited to participate in the Take Home Portion of the study (Part B). Subjects who  
 agree to participate will sign new informed consent forms that explain all study procedures, risks and benefits.  
 
Part B - Home Visit 
The purpose of the home visit is to determine suitability of the home environment for safe home use and to 
identify any potential hazards in the subject’s home environment which may make home use ill-advised. 
Two trained study staff members will visit the subject at home to conduct an assessment of the home 
environment.  Elements of the home safety assessment are detailed in Appendix 2.  At the completion of the 
home study assessment, the site PI in conjunction with Dr. Resnik will determine whether or not the subject‘s 
home environment is safe and appropriate for unsupervised home device use.  This visit may take place over 
two days to allow time for the study staff to discuss the visit with Dr. Resnik and to deliver the Arm on the 
second day. During the home visit the study staff member will walk through the subject’s home to determine 
adequacy of plumbing, electricity, and note general cleanliness, presence of pets, and need for major repairs. 
The staff will identify potential hazards and will discuss these potential hazards with the subject. Together, the 
staff will identify the location where the subject plans to store and electrically charge the investigational 
prosthesis. Study staff will take photographs of the subject’s home to provide detail and documentation of the 
home environment. The subject will be asked to invite their emergency contact person and their caretaker if 
they require one, to be present during this visit.  If the study staff identify any immediate safety concerns or 
recommendations for enhancing the subject’s independence in their home environment they will make 
appropriate referrals and provide additional information. 
 
Part B - Home Usage Monitoring 
Prior to sending the subject home with the DEKA Arm the study staff will review all instructional material and 
make sure that the subject has correct contact information for study personnel. The subject will be informed 
about all potential hazards of the investigational prosthesis and how to avoid these hazards (see Appendix 1) 
and agree to follow the instructions and restrictions given to them by the study staff. If needed, a 
caregiver/companion will be been trained on the use, maintenance, shipping and potential hazards of the 
investigational prosthesis. Subjects will be provided with 24-hour contact information in the event of an 
emergency related to use of the DEKA Arm. 
 
Periodic phone calls to the subject at home will be made during the home usage portion of the study.  The 
frequency of these calls will be no less than 1x/week, but may be increased at the discretion of the study staff if 
there are concerns about compliance or the home environment. 
 
During the first month of home use of the DEKA Arm subjects will be asked to wear and use the arm for a 
minimum of 2 hours per day.  Our expectation is that this requirement will help establish a pattern of regular 
usage. After 1 month subjects will be instructed to wear and use the DEKA Arm as much and as often as they 
wish. Throughout Part B subjects will be asked to maintain daily logs detailing use of the DEKA Arm over the 
course of Part B participation. These daily logs will be mailed to the study staff weekly. 
 
At the monthly in-person study visits, engineering logs will be downloaded from the DEKA Arm and sent to 
DEKA for data extraction.  This technical data will consist of event logs and usage statistics. The event logs 
consist of time stamped lists of selected internal inter-processor messages. These logs are used to monitor 
system performance and assist in trouble shooting technical problems. The engineering usage statistics data 
files consist of histogram data of position/speed/current for each motor drive in the system, as well as 
histograms of battery parameters such as voltage and current. DEKA will provide the Principal Investigator with 
usage summaries for each two week period. These will be compared to the subject’s self-report. 
 
Part B - Biweekly Study Visits: 
Reassessments of self-reported quality of life, prosthetic satisfaction and function will be conducted on a 
biweekly basis. These visits will occur either by telephone, videoconference, or in-person. 
 
Part B – In-person Visits: 

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  In-person visits will occur at least monthly (and may overlap with the biweekly visit). Reassessments of dexterity    
 and function (measured by performance based tests) will be conducted.Subjects will complete surveys that ask   
 about their impressions of the arm, concerns about the arm, prosthetic comfort and fit, and training. In-person  
 visits will be videotaped  to provide qualitative data on functional performance over time. More frequent in-person   
 visits will be scheduled as necessary to address any concerns about arm operation or use. 
 Prior to the start of Part and at all in-person study visits, Arm Usage Data (engineering logs) will be  
 downloaded from the DEKA Arm by the study site and sent to PVAMC for data extraction. 
 
Part B - Final Study Assessment 
The final study visit will include reassessment of all outcome measures tested at baseline (except 
neuropsychological tests), administration of a participant survey and/or semi-guided interview asking about the 
experience of home use of the DEKA Arm, the added benefits, challenges, and maintenance needs. In 
addition, subjects will be asked about their history of falls during the previous month. 
 
Part A and B Additional Considerations 
Poor socket fit 
In the event that a problem with the definitive socket fit and comfort occurs during the study, the prosthetist 
may need to fit and fabricate a new socket. This could potentially require up to an additional 14 visits to fit and 
check the new socket and would only be done if the subject agrees and can accommodate the scheduling of 
additional visits. 
Malfunction of DEKA Arm System 
In the event that the DEKA Arm system malfunctions in any manner, subjects will be instructed to contact study 
staff within 24 hours. If necessary, the study staff will make the determination to put study activities on hold  
and will consult with DEKA systems engineers. If the problem is not resolvable remotely, the arm will be 
shipped back to DEKA and repaired. The repaired arm or a new arm will be returned to the study site and 
study activities will resume.  Subjects will not contact DEKA engineers directly for troubleshooting or repairs. 
Neuropsychological and other health concerns 
Subjects will undergo medical screening prior to enrollment in the study. If, during the course of study activities, 
the study staff suspect any undiagnosed neurocognitive deficits that were not detected upon screening or if any 
other health problems arise, subject will be referred for further evaluation outside of the study. 
 
 Transition to Part B 
 There may be instances where participants need to come into the lab for additional prosthetic fitting or training   
 visits after completing Part A and before beginning Part B to ensure that the prosthetic socket fits well, the DEKA  
 arm and controls are working correctly and/or that the subject has retained the skills gained in Part A.  These  
 visits may be needed if the subject gains or loses weight, if a change to the controls configuration is needed for  
 any reason or if a significant amount of time has passed since completing Part A (>4 weeks).  The Principal  
 Investigator and study staff will consult to determine the best plan of visits on a subject-by-subject basis. 
 
Some subjects, after completing Part A at one site may be invited to continue Part B at a different site.  In this 
case, subjects would make an in-person visit to the new site to meet the staff and have their socket and DEKA 
Arm function inspected prior to their home visit.  These subjects would consent to Part B at the new site and 
information about them will be shared with the study team. This transition may be needed as the study terminates 
at 2 sites but continues at a 3rd site. 
 
Study Data Sources   
We will use standardized outcome measures collected at key intervals over time to examine outcomes of pain, 
dexterity, functional activities, prosthetic satisfaction and quality of life (see Appendix 5).  Most of these 
measures were utilized in the VA Study to Optimize the DEKA Arm. Additionally, we will collect qualitative data 
from home safety assessments (Appendix 2), video logs, surveys, interviews and prosthetic usage journals. 
Each data type is described in the section below. The proposed time frame of data collection is shown in 
Table 6 below. 

Version: 06-16-2017 
 
Home Study of an Advanced Upper Limb Prosthesis 
Lead PI: Resnik 
 
 
 
PART A 
PART B 
Current Prosth esis 
DEKA A rm 
DEKA Arm 
Baseline 
Visits 
1 &2 
Prior to 
DEKA 
Arm 
training 
Visit 
14 
End of 
Part A 
Home 
Visit 
Weekly 
Biweekly 
Monthly 
End of 
Part B 
Outcome Measures 
Neuropsychological testing 
X 
Myosite screening 
X 
Pain 
X 
X 
X 
X 
X 
X 
Dexterity 
X 
X 
X 
X 
X 
Self-reported Functional Activities 
X 
X 
X 
X 
X 
Prosthetic Satisfaction 
X 
X 
X 
X 
X 
Performance based Functional Activities 
X 
X 
X 
X 
Quality of Life 
X 
X 
X 
X 
X 
Community Integration 
X 
X 
X 
X 
X 
Other Data Sources 
Home safety assessment 
X 
Weekly telephone call 
X 
Video logs of performance 
Surveys of patient 
X 
X 
X 
X 
Guided interviews 
X 
X 
Prosthetic usage journals 
X 
X 
Prosthetic usage technical data 
X 
X 
Appropriateness for Home Use 
X 
Final Determination of Appropriateness 
for Home Use 
X 
Estimated time to complete assessment 
2 hours 
10 min 
1.5 
hours 
2 hours 
1. 5 hrs 
10 min 
30 min 
1.5 hours 
2 hours 
 
Table 6. Schedule of data collection plan 
 
 
16 

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Version: 06/16/17 
 
 
 
Standardized Outcome Measures 
Neuropsychological Testing 
All subjects will complete a brief battery of widely-used, standardized, clinical neuropsychological tests at 
baseline to determine the association between cognitive function and success of the DEKA arm intervention. 
The battery is designed to assess all major cognitive domains with emphasis on executive function. It is 
designed to be brief (approximately 35 minutes), easily and reliably administered, and amenable to completion 
by participants with upper extremity amputation. The battery is comprised of following: Color-Word 
Interference and Verbal Fluency Tests from the Delis-Kaplan Executive Function System (D-KEFS),12 
Judgment of Line Orientation (JLO),13   Digit Span and Letter-Number Sequencing subtests from the Wechsler 
Adult Intelligence Scale – IV (WAIS-IV),14   oral versions of the Trail Making Test parts A & B,15 Symbol-Digit 
Modalities Test,16 Shape Learning and Shape Recall items from the Screening Module of the 
Neuropsychological Assessment Battery (NAB),17 and several components of the Repeatable Battery for the 
Assessment of Neuropsychological Status (RBANS).18, 19   Each of these assessment tools is described briefly 
below. We have determined that total administration time for this battery of tests is approximately 45-55 
minutes. 
D-KEFS Color-Word Interference Test12: This test measures the examinee's ability to inhibit an overlearned 
(or prepotent) verbal response (i.e., reading a color word aloud) in favor of an alternative response (i.e., naming 
the color of ink the word is printed in). The Color-Word Interference Test has four parts each involving a 5       
X 10 stimulus array. Practice is allowed for each part.  First, examinees are presented with a card of colored 
squares (blue, green, and red only) and are asked to name the colors as quickly as they can (90 second    
limit). Second, they are asked to read aloud an array of color words (blue, green, and red only) as           
quickly as possible (90 seconds). The third array (interference condition) contains the words blue, green, and 
red printed in an incongruous color ink (e.g., "blue" printed in red or green) the correct response is the color of 
the ink (180 seconds ). The fourth condition adds a cognitive set-switching component. Here, the task is the 
same as in the third condition except some words are surrounded by a box, in which case the correct response 
is to read the word (180 seconds). The examiner records the completion time and number of errors. 
D-KEFS Verbal Fluency Test: This test assesses the individuals’ ability to generate words fluently in a 
difficult phonemic format (Letter Fluency) in comparison to an overlearned format (Category Fluency) and to a 
cognitive set-switching condition (Category Switching). The test has three conditions. The first condition, 
Letter Fluency, requires examinees to say words that begin with a specified letter as quickly as possible in 60 
seconds. Three trials are administered, each using a different letter. In the second condition, Category 
Fluency, examinees say words that belong to a specified semantic category (e.g., animals) as quickly as 
possible in 60 seconds. Two trials are given, each utilizing a different semantic category.  In the third 
condition, Category Switching, examinees say words from two different semantic categories (alternating 
between them) as quickly as possible in 60 seconds. 
Judgment of Line Orientation (JLO) 13: This test of visuospatial processing assesses the ability to estimate 
angles between line segments. Examinees are presented with two cards:  a stimulus card with two angled, 
non-intersecting line segments; and a response card with a semi-circular array of 11 numbered lines drawn at 
18-degree intervals. The examinee is asked is to select two lines from the array that form the same angle as 
line segments on the stimulus card. Practice items are provided.  There are 30 items; we will use a shortened 
(15-item) version. 
WAIS-IV Digit Span 14:This is a test of basic and complex verbal attention (working memory). There are three 
components to this test. All components involve the examiner reading aloud a string of digits in and the 
examinee repeats them according to specific rules. In the first component “digits forward,” the examinee 
repeats the items in the same order the examiner read them. In the second component, “digits backward,” the 
examinee repeats the digits in reverse order. In the third component, “digits sequencing,” the examinee 
repeats the digits in ascending order. There are 10 items each consisting of two trials.  String length increases 
across items 1 through 10. The test continues until the examinee fails all three trials of a particular item. 

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WAIS-IV Letter-Number Sequencing 14: In this test of working memory ability the examiner reads aloud a 
string of alternating numbers and letters (e.g., 4-K-2-Q-7-M). The examinee is required to repeat back the 
numbers in ascending order and the letters in alphabetical order.  There are 10 items each consisting of three 
trials. String length increases across items 1 through 10. The test continues until the examinee fails all three 
trials of a particular item.  Practice items are provided. 
 
RBANS18, 19: The RBANS is a brief battery of 12 neuropsychological subtests that have been used to assess 
cognitive function in a wide variety of conditions including those with dementia, stroke, multiple sclerosis, and 
head injury. We will use the following components of the RBANS: Picture Naming (assesses confrontation 
naming); List Learning, Recall, and Recognition (assesses non-contextual verbal learning and recall); and 
Story Learning and Recall (assesses contextual verbal learning and recall).  Delay times for List Recall and 
Story Recall will be set to approximately 10 minutes. 
Trail Making Test part B (oral): This is a test of cognitive set-switching involving alphanumeric sequencing.9 
We will use an oral version of this test rather than the standardized pencil-and-paper test.15   The examinee 
counts as follows “1-a, 2-b, 3-c . . . 12-l”. The examiner records completion time and errors. 
NAB Shape Learning and Shape Recall (Screening Module) 17:  In this test of visual learning and memory, 
examinees are shown a series of five abstract shapes, one at a time, for 5 seconds each. This is followed by 
the Immediate Recognition trial in which the examinee is shown a series of five 2 x 2 arrays. Each array 
contains one of the five shapes learned earlier (target) and three similar shapes (distracters). The examinee is 
asked to identify the target. We will modify this task by having examinees indicate their selection verbally (i.e., 
“upper right”) rather than pointing. The Delayed Recognition trial is administered approximately 10 minutes 
later. The score is the number of items correctly identified in the recognition trials. 
 
Symbol-Digit Modalities Test16:  In this widely used test of mental processing speed involving digit-symbol 
matching. Examinees are presented with a sheet of paper. The top of the page shows a “key” showing the 
digits 1-9 each paired with an abstract shape. The remainder of the page consists of rows the symbols in 
mixed order. The examinee is asked to write or state the number that should be matched with the symbol 
based on the key (which remains in plain view at all times) and to complete as many items as possible 
correctly in 90 seconds. 
 
Pain 
Wong-Baker FACES Pain Rating Scale (FACES)20: The FACES is a commonly used 6-point pain scale that 
utilizes faces to indicate the intensity of pain. The subject is asked to choose the face that best describes how 
he/she is feeling. 
 
Dexterity 
Jebsen-Taylor Hand Function Test (JTHFT) 2: This seven-part test evaluates the time needed to perform 7 
hand-related tasks including: 1) printing a 24-letter, third-grade reading difficulty sentence, 2) turning over 7.6 x 
12.7 cm (3x5”) cards in simulated page turning, 3) picking up small common objects including pennies, paper 
clips, bottle caps and placing them in a container, 4) stacking checkers, 5) simulated feeding, 6) moving large 
empty cans and 7) moving large 1 lb. cans. The subtests are scored by recording the number of seconds 
required to complete each task.  Additionally, we will count the number of sub-activities completed within the 
allotted two minutes. Increased time to complete the subtest is related to decreased function of the hand. The 
JTHFT will be administered with the subject seated on an 18 inch stool in front of a table of 30 inches in height. 
Only the involved side (i.e. prosthetic side) will be tested.  Subjects are limited to two minutes to complete each 
sub-test. The entire test takes about 15 minutes to complete.  Prior studies have reported excellent test-retest 
reliability.21 This test has been widely used as an outcome measure of upper limb function in studies of 
prosthetics,22 orthotics,23 wrist arthrodesis,24 stroke,25-28    brain injury,29 arthritis,30, 31 and nerve injury.32 
Normative values for time-based adults have been published.2 

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Functional activities 
Performance Based Functional Activities 
University of New Brunswick Test of Prosthetic Function (UNB) 33: The UNB test, one of the best known 
measures in the upper extremity prosthetics, was originally developed for children.34 However, others have 
used the age-appropriate activities from the UNB test as a measure of prosthetic function in upper limb 
prosthetic training for adults who are not amputees.35   Inter-rater reliability of the rating scale in a pediatric 
amputee population has been reported as 0.73-0.91. This test will be used for unilateral amputees only. We 
will use one of the subtests of activities designed for ages 11-13 year olds, which include activities that are 
appropriate for adults. The subtest we will use includes the following activities: wrapping a parcel, sewing a 
button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush.  No instructions 
will be given regarding the use of the prosthesis; instead the subject will be directed to do the activity. 
Performance on the UNB test will be videotaped and the test scored from the video by two VA Credentialed 
independent raters who are trained in the UNB scoring system.  For each of 10 tasks, the amputee is rated on 
a 5-point scale of 0-4 for dual functions: spontaneity of prosthetic function and skill of prosthetic function. 
Spontaneity measures the extent to which the amputee has incorporated the prosthesis into his or her body 
image and measures the tendency to use the prosthesis to assist with the task.  Skill measures the dexterity 
with which the prosthesis is used. It includes the ability to open and close the terminal device to grasp and 
release objects with confidence, speed and consistency and maintain grasp without letting go accidentally, and 
apply correct amount of pressure.  Spontaneity is rated first, then skill. 
 
Activities Measure for Upper Limb Amputees (AM-ULA): The AM-ULA is an 18-item measure that assesses 
key elements of functional performance with a prosthesis: the ability of the amputee to complete daily   
activities, the speed of the performance, the movement quality, skillfulness of prosthetic use and  
independence. The AM-ULA is a new observational outcome measure of activity performance developed 
during the VA Study to Optimize the DEKA Arm to address the need for a validated functional activity measure 
for adults with upper limb amputation. It was implemented part-way through the Gen 2 protocol. The 18 items 
of the test include: brush/comb hair, put on a T-shirt, remove a T-shirt, button shirt, zip a jacket, put on socks, 
tie shoe laces, drink from a paper cup, use a fork, use a spoon, pour from a 12 oz can, write the word 
“LETTER” legibly, use a pair of scissors, turn around doorknob, dial a touch tone phone, use a hammer and 
nail, fold a bath towel, and reach overhead and grasp an object. Each item of the AM-ULA test was videotaped 
and the performance was independently scored by two certified hand therapist raters who were trained in the 
scoring criteria and blinded to the subject’s visit number. Extensive psychometric evaluation of the new 
measure was conducted examining test-retest reliability, inter-rater reliability, and internal consistency. We then 
chose only those items that had at least moderate (0.5 or above) test-retest and inter-rater reliability to    
include in the final version of the activity measure. To validate the new measure we used ANOVAs to compare 
scores at the first testing session (Visit 1) for subjects by level of amputation, expecting that subjects with more 
proximal levels of amputation would have lower (worse) scores than those with more distal (i.e. transradial) 
amputations. We also used ANOVAs to compare mean scores (mean of independent raters 1 and 2) for each 
activity item by amputation level.  Analysis showed that the AM-ULA had excellent test-retest reliability, inter- 
rater reliability and internal consistency.  Scores of transradial amputees were significantly better than those of 
transhumeral and shoulder level amputees. 
 
Extended Activities Measure: The Extended Activities measure is an observational measure of ability to 
complete specific activities. This assessment tool was implemented for the Gen 3 portion of the study.  The 
eleven activities included in this measure were: tuck shirt in pants, pull down pants, reach a container on a 
high shelf, open a water bottle, lift a 20 lb box from the floor, remove a wallet from the back pants pocket, 
replace the wallet in the back pocket, take a gallon jug of water from the refrigerator, open and pour water 
from a gallon jug, pick up an egg from a carton, and carry a 20 lb bag. Therapists used a standardized set of 
instructions to administer this test. All activities were graded by the site therapist as “0” unable to complete, or 
“1” can complete. A standardized definition of each activity was used in the grading. 

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Rivermead Extended Activities Index (REAI): The REAI is an Instrumental Activities of Daily Living (IADL) 
measure that was developed to measure functioning in the stroke population, many of whom have upper limb 
involvement (Whiting and Lincoln 1980). Several studies support the reliability and inter-rater reliability of the 
REAI. Test retest reliability for persons post CVA was reported to be 0 .95. -0.97 (Whiting and Lincoln 1980; 
Rossier, Wade et al. 2001). The REAI was validated for persons with stroke and elderly persons (Whiting and 
Lincoln 1980; Lincoln and Edmans 1990). The REAI is a performance based measured that is scored on a 
three-point scale: 1, dependent; 2, independent but requires verbal supervision; and 3, independent. It has 
been used in young stroke patients (<65 years) and elderly stroke patients (>65 years) (Hamrin 1982). We will 
also add a timed element to the testing procedures. 
 
Self-reported Functional Activities   
Upper Extremity Functional Scale (UEFS) from the Orthotics and Prosthetics Users Survey (OPUS): 6, 7 
The UEFS is a self-report measure developed for use with upper limb adult amputees. UEFS items ask clients 
to evaluate the ease of performing 23 activities including self-care and instrumental daily living tasks using a 5- 
point scale from “1” very easy to “5” cannot perform. Items include activities varying from washing, buttoning 
shirt, tying shoe laces, using fork or spoon, and writing name, to donning and doffing the prosthesis.  All 
activities on the UEFS test will be included as part of the standardized training protocol for the study. 
Preliminary analyses of the UEFS were done using a sample of amputees in Slovenia and the Slavic version of 
the UEFS. We will supplement the items on the UEFS with up to a dozen other functional activities identified 
as important for daily living. 
 
The Patient Specific Functional Scale (PSFS): The PSFS is a patient-specific outcome measure to assess 
functional status.5 Patients are asked to identify up to five activities that they have difficulty performing due to 
their condition and then rate the amount of limitation they have in performing these activities on a scale of 0 to 
10 with 0 being unable to perform the activity and 10 being able to perform the activity with no problem. 
Individual items are scored separately. The PSFS has been shown to be valid and responsive to change for 
patients with neck pain, cervical radiculopathy, knee pain and low back pain.37, 38 Its use with upper limb 
amputees has not been previously explored. 
 
QuickDASH Outcome Measure: The QuickDASH is an 11 item self-report measure developed from the 
original 30-item Disabilities of the Arm Shoulder and Hand Measure (DASH). Each scale item has 5 response 
options ranging from 0 (no disability) to 100 (most severe disability).  At least 10 of the 11 items must be 
completed for a score to be calculated. The assigned values for all completed responses are summed and 
averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one 
and multiplying by 25. A higher score indicates greater disability. 
 
Prosthetic satisfaction 
Trinity Amputations and Prosthetics Experience Scale (TAPES):  The TAPES was originally developed for 
people with lower limb amputations, but has recently been used for persons with acquired upper limb 
amputations.8   The TAPES assesses three primary areas: psychosocial adjustment, activity restriction and 
satisfaction with the prosthesis. We will use the 10 item scale related to prosthetic satisfaction which include 
questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, 
comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device.8   Each item is 
rated on a 5-point scale from very dissatisfied to very satisfied.  Cronbach alpha (internal consistency) for the 
prosthetic satisfaction scale for upper limb amputees has been reported as 0.94.8 
 
Quality of life 
SF-36 V: Four scales of the SF-36V (Veterans version) will be used to assess quality of life. The Role Physical 
Scale is a 4-item subscale that measures difficulty with role function in work or daily activities attributable to 
physical health problems. 39 The 3-item Role Emotional subscale measures difficulty with role function in work 
or daily activities attributable to mental health problems. Finally the 2-item Social Functioning subscale 
measures interference with social activities related to physical and emotional problems. 39 The Physical 

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Functioning Subscale (PF-10) is a 10-item subscale of the SF-36 that measures difficulty with performance of 
physical activities.39 
 
Quality of Life Scale (QOL): The QOL consists of 16 questions that assess satisfaction with independent 
living and self-care activities. 40 
 
The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT): The CRIS 
measures community reintegration of veterans, using the construction of participation as defined by the WHO’s 
International Classification of Health and Functioning. The CRIS-CAT, developed with funding from VA 
HSR&D, was recently developed from the CRIS. 41   It consists of three scales which assess three different 
dimensions of community integration, extent and frequency, perceived limitations, and satisfaction. CATs for 
all three scales require 10-20 items to achieve accuracy above .88. 
 
Other Data Sources 
Home Usage Logs - Part A: Subjects will be asked to maintain home usage logs which document the number 
of hours per day that they wore their existing prosthesis, and the estimated number of hours that they actually 
utilized the device.  They will also be asked to identify the major types of activities that they performed using 
their prosthesis by checking off Yes/No to major categories of use including: household chores, driving, 
cooking, eating, recreation, working. Usage logs will also provide space for additional comments. 
 
Home Usage Logs - Part B: We expect that subjects will utilize both their existing prostheses and the DEKA 
Arm during the home study portion of the trial. Thus, home usage logs for Part B while similar to those of Part 
A, will also ask specifically about the use of the DEKA Arm. 
 
Activity monitoring/engineering logs: DEKA engineering data files consist of histogram data of 
position/speed/current for each motor drive in the system, as well as histograms of battery parameters (i.e. 
voltage and current.) DEKA will provide the PI with usage summaries for each two week period. 
Open Ended Survey questions: Study-specific surveys will contain both open-ended questions as well as 
quantitative scales specific to use of the Gen 3 DEKA Arm. Open-ended questions will ask about the subject’s 
overall impression of the DEKA Arm, the experience of using the arm at home, and will ask the subject to 
compare the DEKA Arm to current prosthetic device. 
Semi-guided interviews: After the last visit, subjects may participate in a semi-structured interview 
administered by the study therapist or research assistant and will be audio recorded. During these interviews 
subjects will be asked to expand on the questions asked in the open ended survey questions, to talk about the 
DEKA Arm and their lifestyle.  See Appendix for examples of semi-guided interview questions. 
Audio Logs: At each session the subject and study staff will be provided with digital hand held micro recorders 
and asked to record comments for the investigative team before, during, or after their scheduled visits. Audio 
files will be uploaded to VA secure Sharepoint or FTP site and will be transcribed verbatim for analysis. 
Video Logs: Part A baseline and baseline retesting and reassessment visits will be video recorded.  Part B 
biweekly study visits and the final study visit will be video recorded. Additionally, per request of Dr. Resnik or at 
the discretion of the site study staff, set-up and training visits may be recorded to capture important milestones 
or other information. Video logs will be recorded and video data stored on the study secure content server or (if 
recorded via handheld video camera) will be stored in a restricted folder on the PVAMC P: Drive. 
 
Data Analysis 
1. Identify and describe upper limb amputees who would be appropriate candidates for home use of 
this advanced prosthesis, as well as those who would not be appropriate. 
All subjects will participate in Part A of the study, which will involve supervised, in-laboratory training, as well as 
supervised community based outings. Based upon the findings from Part A, study staff will classify participants 
as appropriate or not appropriate for participation in Part B (the home usage portion of the study). This 

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classification will be based upon a specified set of criteria established to determine potential for safe home 
usage, as well as the completion of all aspects of Part A study activities. Safe home use criteria will include 
elements such as skillfulness of prosthetic use, independence in daily device maintenance and storage and 
safety awareness. 
 
We will calculate the percentage of subjects who participate in Part A of the study who are determined to have 
met the preliminary criteria for home use appropriateness. Based upon our early experience in the VA study to 
optimize the DEKA Arm, we expect this percentage to be as high as 75-80%.  For those subjects who are 
invited to participate in Part B and consent to do so, we will then calculate the percentage whose home 
environment is considered appropriate to allow home use. 
 
We will then describe the subjects in each group and examine characteristics of those subjects who were not 
considered appropriate candidates for home use to identify which, if any factors were predictive. Analysis of 
variance (ANOVA), t-tests, and χ2 analyses will be used to compare the appropriate vs. non-appropriate 
candidates on demographic and clinical variables: age, amputation level, years of education, results of 
neuropsychological testing. We hypothesize, based upon our preliminary experience, that subjects with long 
response times for Trail-Making B test may not possess the speed of executive function to enable them to be 
deemed safe and appropriate home use candidates. 
 
2. Compare the extent of use of the existing prosthesis to that of the DEKA Arm. 
Subjects will be asked to maintain daily logs detailing usage of their current prosthesis. Additionally, subjects 
may be asked to wear an activity monitor for prosthetic use (the exact device would be determined through 
pilot work). This data will be collected several weeks prior to in-lab training with the DEKA Arm.  Quantitative 
measures of existing prosthetic activity gathered prior to the initiation of the in-laboratory training will be 
compared with measures taken during the last 2 months of home use of DEKA Arm. We will utilize measures 
such as logged hours of wear time, hours of use time, and number of times that grips were used (gleaned from 
automated activities measures and engineering logs). This comparison will allow us to assess adoption of the 
DEKA Arm in an unsupervised home environment. 
 
3. Quantify the impact of home use of the DEKA Arm on device satisfaction, performance of functional 
activities and the user’s quality of life. 
We will use a time series design to examine changes in device satisfaction, performance of functional activities 
and quality of life throughout the study.  Each subject will serve as their own comparison using within subject 
pre and post intervention measures.  To determine whether changes occurred in key dependent variables from 
baseline with the current prosthesis (Part A) to end of supervised training (Part A) we will use paired t-tests. 
We will also examine changes in key outcomes from the end of Part A supervised training to the conclusion of 
the home trial (Part B). Additionally, we will examine the influence of successive usage of the DEKA Arm 
through linear regression models testing the principle effect of time. 
 
4. Quantify the amount and type of technical support and repairs needed during the study, and 
estimate the number of home study days lost due to service/repair. 
We will gather descriptive data on technical support usage, including number and content of calls and email 
exchanges with DEKA support, number and type of repairs needed during the study.  Study sites will be asked 
to document each of their contacts with DEKA technical support and forward this information to the PVAMC 
coordinating site. We will summarize this information across subjects and levels of arm type. This information 
will be useful in estimating service needs for clinical deployment. 

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Risks to Subjects 
Human Subjects Involvement and Characteristics 
Sample 
Part A: We expect that we may need to enroll up to 75 amputees across all sites in order to yield complete 
Part A data on 40 subjects. This is due to anticipated screen failures (estimated at 20%) and the likelihood that 
some 20% of subjects (based upon prior study experience) who do meet eligiblility criteria will not be able to 
participate in all research activities. Additionally, we will purposefully sample subjects to insure that we have an 
even distribution of subjects at each level of DEKA Arm fit during Part B (10 SD, 10 TH, 10 TR). 
 
Part B: We expect that up to 20% of Part A participants may not be considered appropriate for home study 
usage. Thus, we expect that up to 36 participants who have completed Part A of the study will be invited to 
participate in the home study portion (Part B) of the study. We will purposefully select subjects who have 
completed Part A and who are judged to be appropriate candidates for home use (see Part A Preliminary 
Determination of Appropriateness for Unsupervised, Home Device Use.) Our goal is to have complete data on 
up to 30 subjects with the Gen 3 DEKA Arm. We plan to include approximately 10 subjects fit at each of the 3 
levels of amputation (SD, TH, TR). We estimate that 20% (or 4 subjects) may terminate the study early. 
 
For both parts of the study, an estimated 80% of subjects will be veterans enrolled in the VHA or DoD 
healthcare systems. Approximately 20% of subjects may be non-veterans whose participation may be needed 
to meet sampling goals for amputees with higher levels of limb loss, and to insure the inclusion of female 
amputees. Subjects who have participated in the VA Study to Optimize the DEKA Arm or the VANYHSS Pilot 
Study to Optimize the DEKA Arm will be eligible to participate in this study. 
 
Sources of Materials 
The sources of research material will be tests and questionnaires administered to subjects as well as audio 
and video recordings all obtained with written informed consent. These data will be used for research 
purposes only. 
 
Potential Risks 
The risks of participation in this study are minimal and are similar to that of being fit for and using a standard 
commercial battery powered artificial arm. 
 
a) There is a small risk of injury or property damage resulting from improper use of the DEKA Arm under 
extreme or dangerous conditions. 
b) There is a small risk of redness on the skin where the socket is attached. The redness will typically be gone 
within one day of wearing. 
c) The subject may experience some soreness due to the weight of the prosthetic arm and the frequent use of 
the device during training and testing. 
d) There is a risk that the prosthetic arm may possibly bump into the subject’s body or head during function. 
e) There is a risk that the battery on the DEKA Arm could overheat and cause burns. 
f) There is a risk that wearing the DEKA Arm may cause subjects to experience discomfort in their back and/or 
shoulder, or that they may experience an increase in pre-existing pain in their back and/or shoulder. To 
minimize the potential for this, subjects may be asked to stop wearing the arm, and take a break if they begin 
to experience pain as a result of wearing the DEKA Arm. 
g). There is a risk that repeated use of the DEKA foot controls may cause the subject to experience discomfort 
in their ankle, or that they may experience an increase in pre-existing pain in their ankle. 
h) There is some risk of loss of confidentiality in sharing personal experiences or opinions and having 
performance evaluated through videotape, audiotapes and surveys. 
 
Adequacy of Protection Against Risks 
 
Recruitment and Information Consent 

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A number of methods will be utilized to recruit subjects into the study. First, clinical staff from study sites will 
inform potentially eligible subjects about the study and invite them to participate. Second, email notifications 
regarding the study will be sent periodically to national list-servs for prosthetic and rehabilitation staff. Third, 
approved flyers and brochures will be distributed at VA/DoD medical centers, private prosthetic treatment 
centers, and other locations that upper limb amputees might frequent. Fourth, we will distribute press-releases 
to news groups as well as consumer organizations including the Amputee Coalition of America, Wounded 
Warriors, and the Disabled Veterans of America. Thus, potential subjects who show an interest in participating 
can learn more about the study from this informational material.  Finally, subjects who participated in earlier VA 
studies of the DEKA Arm, who consented to be contacted in the future will be informed about the new study 
and invited to participate. 
 
Consent process 
After initial telephone screening to assess eligibility criteria, each potential subject will be scheduled for an in- 
person assessment which will be held in a private area. Before the assessment begins, the site PI, Research 
Assistant, or prosthetist will explain the study protocol. Subjects will be asked to make a commitment to be 
available for all study activities. Individuals will be given adequate time to review and comprehend all 
information about the study before agreeing to take part, minimizing the possibility of coercion and undue 
influence. 
 
Protection Against Risk 
We will make every effort to protect study participants against these risks as outlined below. The research 
protocol will be approved by the Institutional Review Boards of each participating VA site and PVAMC before 
any data collection begins. 
a) Risk of injury: Subjects will be provided with a detailed list of prohibited activities and usage advisories (See 
Appendix 1).  Subjects will not be cleared for home use of the DEKA Arm unless they have demonstrated a 
good comprehension of these safety concerns. In addition, all subjects will have a home safety assessment to 
insure that they have an adequate environment for using, charging and storing the arm. 
 
b) Risk of skin redness: If redness persists, the Site Principal Investigator and prosthetist will be notified and 
modifications to the socket will be made as necessary. 
c) Risk of soreness: Rest breaks will be provided to minimize this risk. 
 
d) Risk of bump to body or head: The movement of the DEKA Arm will be set slow enough that the subject will 
be able to reposition the entire prosthesis or move their body to another position to avoid being bumped. 
During initial in-laboratory training, subjects using powered shoulders will wear safety glasses if appropriate. 
Furthermore, the prosthetic device will only be used under the supervision of study staff. During initial training, 
subjects will not be left unattended while wearing the prosthetic device. Only those subjects who have 
achieved competency with the DEKA Arm (as defined by the study protocol) and are approved by study staff 
will be allowed to take the arm home for unsupervised use. 
e) Risk of battery overheating or burning: To minimize the potential for problems, all batteries are tested by 
DEKA in a manner that simulates their use in the prosthetic arm. The batteries used in the DEKA Arm are 
similar to those presently used in commercially available powered prosthetic arms. 
 
f) Risk of loss of confidentiality: Participants must sign an informed consent indicating their willingness to 
participate in the study, their willingness to be audio taped/recorded and videotaped, their understanding of 
risks and benefits and their understanding that participation is voluntary. Unless required by law, only the study 
investigators, members of the investigator’s staff and the IRB will have authority to review study records. To 
protect confidentiality, each subject will be given a unique identification number that will be used in the name 
field of all study related paperwork. The study numbers will be kept separate from the data and will not contain 
any personal information.  All data regarding subjects (paper and pencil surveys, audiotapes, and data 
collection forms) will be kept confidential and stored in a secure location (locked filing cabinets) at each 

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VA/DoD site. Study materials will be stored in accordance with VA Record Control Schedule 10.1 and may also 
be used for scientific presentation. 
 
All electronic copies of study files will be maintained on the Providence VAMC secure research server in the 
DEKA-R or DEKA-DATA-R folders. OI&T staff is responsible for all electronic data back-up. Each site will 
maintain copies of de-identified data in locked filing cabinets within each designated research office. 
Potential Benefits of Research to Subjects and Others 
Participation in this study will allow subjects to try a new investigational prosthetic device. There is currently no 
commercial prosthesis which affords the same control features and functional capability as the DEKA Arm. As 
a result, we expect that some study participants will be able to perform more daily activities with greater ease 
while using the DEKA Arm as compared to using their existing prosthesis. The study protocol involves 
intensive training and prosthetic education which may carry over to use of their existing prostheses. This 
training and education has the potential to result in functional improvements with their current devices. 
 
Importance of Knowledge to be Gained 
Information gleaned from this study will be critically important in moving the DEKA Arm closer to 
commercialization and successful dissemination and deployment within the VA system of healthcare. An 
important outcome of this study will be the development of clinical guidelines for prescription of the DEKA Arm. 
Currently, VA Prosthetics and Sensory Aids has few, if any, clinical guidelines to inform prescription of 
advanced technologies, determine appropriate candidates or readiness for home use of prosthetic devices 
 
Data and Safety Monitoring Plan 
A Data Monitoring Committee is not required for this project. The Principal Investigator will have primary 
responsibility for day-to-day monitoring of the quality of operations in all data collection, data cleaning and 
transfer activities. 
 
The research protocol will be approved by the Institutional Review Boards of PVAMC, VANYHHS, Tampa VA, 
and the CFI before any data collection begins. 
 
Serious adverse events and all unexpected adverse events will be assessed continuously and as reported to 
the PI immediately. Monitoring by the IRB/R&D is conducted at the continuing reviews as scheduled, whenever 
modification requests are considered, and upon receiving reports of adverse events from the investigator or 
anyone else. 
 
Other information 
Acknowledgment of VA policy to include women and minorities in clinical research 
Neither women nor minorities will be discriminated against in the recruitment of subjects for this study. 
Although the population of veteran upper limb amputees is predominantly Caucasian males, we will make 
every attempt to include both women and minority subjects in the study. 
Financial Information 
Subjects will not be charged for any study-related procedures. After the study concludes, the fabricated socket 
and the DEKA Arm will be returned to the research group.  All non-active duty subjects will be paid a stipend of 
$80 per completed visit which amounts to approximately $25/hour for time spent participating in the in- 
laboratory training and testing activities.  Subjects will be paid $10 per day for in-home usage monitoring. To 
encourage return of the DEKA Arm, the final payment may be withheld until the arm is returned. 
 
Visits may be split into 2 sessions to accommodate scheduling needs for subject and study staff. In these 
instances, subjects will be paid an $80 stipend for the overall visit, but provided with travel and meals 
reimbursement by the day. Additionally, non-active duty subjects will receive a $10 meal allowance for any 
visits (excluding those that take place at distant sites for prosthetic fitting) that take more than 3.5 hours, and 
$30 flat travel allowance per day (excluding those days spent away from home) If subjects require more visits, 

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they will be reimbursed accordingly. 
 
Reimbursement for active-duty participants will be made in accordance with applicable military rules and 
regulations. Military policy prohibits those who are active duty military from receiving stipends and/or gift cards. 
Therefore subjects who are active duty military will not be offered stipends for participation.   For those not 
eligible to receive stipends, we may (if the site specific IRB agrees) donate the gift card to that participant’s 
Family Readiness Group (FRG) or other community/social service organization serving wounded warriors. 
 
Special note: Some subjects may be invited to participate in presentations and demonstrations of the DEKA 
Arm during or following completion of study activities. These Public Relations activities are not considered to be 
part of study protocol activities. These sessions are optional and subjects will be informed that their 
participation in current or future study activities will not be impacted in any fashion by their decision to 
participate in such presentations or not. If the subject agrees to participate they will be asked to sign a 
separate PR Release form (distributed by Public Affairs).  All travel costs associated with such activities will be 
paid for by the VA. 
 
Special Travel Funds 
Additional, supplemental travel funds will be available for use at the discretion of the Study PIs to defray costs 
of nightly hotel accommodations, travel and per locality based per diem expenses for subjects and caregivers 
who must travel more than 2 hours (each way) to participate in study activities at the participating VA sites. We 
expect that up to 50% of subjects at each site will need to travel and stay overnight to participate in study 
activities. 
 
Reimbursement for Subjects Study Time 
Subjects who travel for participation in study activities will be paid $80/day, plus an approved locality based per 
diem meal allowance during the time they are away. In addition, we will cover costs of hotel expenses during 
the stay as well as transportation from their home.  For subjects who need to travel with a caregiver, we will 
provide a per diem for the caregiver as well as travel expenses. 
 
Withdrawal from Study 
If subjects withdraw from the study, they will be paid for the visits they participated, but not for any additional 
days. 
 
Withdrawal information 
Subjects have the right to withdraw from the study at any time by notifying the Principal Investigator orally or in 
writing. Subjects can also be withdrawn from the study at the discretion of the site PI due to non-compliance, 
missed appointments, not following instructions, illnesses or problems that affect participation in the study. If 
subjects withdraw or are withdrawn from the study, all photographs, audio and/or video recordings up to the 
point of withdrawal will remain on file for research purposes. Subjects who withdraw will be asked to come to 
the study site for a final visit and complete all end of study questionnaires and testing. If the subject is unable 
or unwilling to come to the study site for a final visit and is in possession of the DEKA Arm at the time of 
withdrawal, they will be required to make arrangements to ship the arm back to the study site.  All shipping 
costs will be covered by the VA. 
 
Termination 
Subjects may be terminated from either portion of the study at any time at the discretion of study staff if there 
are concerns about physical, mental or behavioral health that may impact the wellbeing of the subject or staff. 
 
Data Collection Procedures: 
All data for this study are collected at participating study sites using a study code (i.e. subject number) that 
does not identify the patient. No primary data is collected by PVAMC (therefore there are no consent   
forms approved for PVAMC).  All data is transferred via secure VA approved methods to PVAMC study staff 
for data analysis. 

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The following types of data are collected for this study: 
- paper data 
- electronic data 
- photograph and video data (note subjects must sign a separate consent for use of Picture/voice). 
 
Data Transmittal Procedures: 
Electronic VA sensitive data or information collected as part of this protocol may only be transmitted using VA- 
approved solutions such as FIPS 140-2 validated encryption. Electronic data sent via regular mail or delivery 
service, such as on disk, will be encrypted with FIPS 140-2 validated encryption and will be sent via delivery 
service with a chain of custody. 
 
Data Storage: 
All electronic VA sensitive information will be stored on the secure VA server located at: 
\\vhaprofpc14\Research\DEKA-R 
\\vhaprofpc14\Research\DEKA-DATA-R 
 
All paper VA sensitive information will be stored in the research offices of Linda Resnik in Building 32. 
All data collected in connection with this research study will be stored in the VA protected environment. No VA 
sensitive data will be transmitted outside the VA, with the exception of photographs and videos that are sent to 
DEKA staff as part of the study CRADA between the VA and DEKA. 
 
Study data will be entered by study staff directly to the Providence VAMC secure research server folders listed 
above. OI&T staff is responsible for all electronic data back-up. 
 
All mobile devices used as part of this study will be encrypted (FIPS 140-2 validated). 
Data collected from this study will be used for research purposes only.  No patient identifiable information will 
be released or published without written permission unless required to do so by law. 
 
Training of Study Staff: 
All study staff listed on this project will maintain up to date training for Information Security Awareness and 
Rules of Behavior. In addition, DEKA staff working on this project take all required research training as 
required by the VA Business Associates Agreement (BAA). Training certificates for VA and DEKA staff are on 
file with the PVAMC Research Office. 
 
Data Access: 
Only VA study staff listed on the IRB application will be given access to study files (paper, electronic, photo and 
video). The study PI will terminate access to study records when a user no longer requires access to them.       
If there is a theft, loss, or other unauthorized access of study data or storage devices associated with this study, 
this will be reported according to VA regulations. 
 
 The study PI and VA study staff listed on the IRB application will also access study records collected during the     
 “VA Study to Optimize the DEKA Arm” for further analysis as part of the Home Study data analysis and  
 reporting. This will enable us to build on study results from the Optimization Study by including a larger sample  
 size, and/or analyze the data in different ways. All access and use of study records from the Optimization Study  
 will be terminated after IRB approval of study closure for the Home Study of an Advanced Upper Limb 
Prosthesis protocol 
 
Data Analysis: 
As data is collected, it is entered into Microsoft excel or word and then transferred to the appropriate statistical 
programs (STATA, SAS, SPSS, NVivo) for analysis. The PVAMC Research Service maintains the licenses for 
all listed statistical software. 
 
All data collected as part of this study will be stored and analyzed at the PVAMC. A summary of the data 
analysis will be shared with DEKA per the VA- DEKA CRADA. This summary will not contain any identifiable 

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data. Only VA non-sensitive data will be transmitted electronically via internet for discussion during study 
meetings. 
 
 In most cases, study results will report on individual case analysis and analysis of combined data gathered from   
 people taking part in the Home Study. There may be times that the lead investigator wishes to compare and/or   
 combine data collected during the Home study with data from the “VA Study to Optimize the DEKA Arm”. To 
 maintain participant confidentiality reports resulting from data analyses will not contain identifiable data. 
 
Data Removal: 
In the event that VA sensitive electronic data requires removal from the VA protected environment, the PI will 
obtain written approval from the supervisor and concurrence from the ISO and CIO. In addition, the PI will 
obtain written approval from the supervisor and concurrence from the ISO and PO to physically remove VA 
  sensitive information in paper format from the VA protected environment in connection with this study. 
 
Other: 
Records will be maintained in accordance with the Department of Veterans Affairs Record Control Schedule 
10-1. In the event that theft, loss of other unauthorized access of sensitive data or storage devices and non- 
compliance with security controls occur, study staff has been instructed to follow the Providence VA Medical 
Center’s standard operating procedure on incidence reporting. 
 
Project Management Plan: 
This study will be directed by Principal Investigator Linda Resnik, a physical therapist researcher who is based 
at the Providence VA Medical Center.  Dr. Resnik has already assembled a highly qualified team of 
collaborators across VA and DoD sites, and has a demonstrated track record of multi-site leadership in upper 
limb prosthetics research. The PVAMC research team is the only team in the country who has direct 
experience with the DEKA Arm and is well prepared to lead the proposed study.  The PVAMC team includes a 
project manager, data manager, research assistant, qualitative data analysts, and several graduate students. 
The proposed study will keep this research team intact, utilize study staff at 3 of the 4 data collection sites who 
participated in the VA Study to Optimize the DEKA Arm, and add up to 2 additional sites in a staggered 
fashion. 
 
Dr. Resnik’s team will be responsible for orienting and training Research Assistants and study staff at all sites. 
The Study Lead Prosthetist will be responsible for working with DEKA as needed to train any new prosthetic 
staff added to the study. Dr. Resnik will be responsible for training study therapists. Each site will be staffed by 
a Site Principal Investigator, at least one prosthetist and therapist (either OT or PT), study physician (who may 
be the PI), and a research assistant. Some sites may also have additional back-up staff.  At the outset of study 
activities or major changes to the protocol a site visit will be conducted by Dr. Resnik and the Project Manager 
for in-person orientation and training. Per request of Dr. Resnik, the lead prosthetist may also travel to assist in 
training team members at sites. The project team will meet weekly through telephone and videoconferencing 
to discuss project activities. The project team will convene annual for a group meeting. Additionally, group 
training sessions will be held as needed at the PVAMC or other study locations. 
 
VA RR&D has already made a major investment in purchasing dedicated IT equipment specifically for Dr. 
Resnik’s study of the DEKA Arm. The current study of the DEKA Arm has an established videoconferencing 
network with secure VA video equipment hosted and maintained by VA OI&T. PVAMC owns 4 Tandberg 
videoconferencing systems for use at data collection sites, and another 4 systems for service, support and 
communication. In addition, PVAMC owns a dedicated content server specifically for the VA Study to Optimize 
the DEKA Arm, and maintains Tandberg service contracts for all equipment. Additionally, PVAMC has an 
established secure VA Sharepoint as well as a secure FTP site for sharing study documents and files between 
sites. We expect to utilize this IT network and equipment in the proposed study. 
 
Whenever possible audio wave files, handheld video files and surveys will be uploaded to a study specific VA 
maintained secure Sharepoint or FTP sites. In the event that this is not possible, all data files will be mailed to 

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PVAMC using a secure courier and tracking number. All video and audio data will be kept on the study’s 
secure content server or on the PVAMC P: drive in a restricted folder. The PVAMC research team will be 
responsible for timely transcription and data entry. Results of quantitative tests and measures will be scored 
and analyzed in an ongoing fashion by Dr. Resnik’s team. 
 
 
Duration of the study and timeline 
Project activities as shown in the Gannt chart below (Table 7)  will commence immediately upon funding and 
receipt of IRB approval.  We anticipate that the length of the data collection period will be a minimum of 36 
months and that we will need 6 months for data analysis and dissemination activities. 
 
Year 1 
Year 2 
Year 3 
Year 4 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Qtr 1 
Qtr 2 
Qtr 3 
Qtr 4 
Qtr 1 
Qtr 2 
IRB approval 
x 
Staff training 
x 
Part A data collection 3 sites 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Part B data collection 3 sites 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Training new site staff 
x 
x 
Data collection site 4 
x 
x 
x 
x 
x 
x 
x 
x 
Data collection site 5 
x 
x 
x 
x 
x 
x 
x 
Preliminary data analysis 
x 
x 
Data analysis 
x 
x 
x 
Dissemination and reporting 
x 
x 
Table 7. Timeline of Study Activities 

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