Brasthesis Prototype for Women Veterans With Upper Limb Amputations
Phase: NA
Conditions: Upper Limb Amputation
Sponsor: VA Office of Research and Development

 
 
 
 
 
      
PROTOCOL TITLE: 
Brasthesis™ Prototype for Women Veterans with Upper Limb Amputations  
 
PRINCIPAL INVESTIGATOR: 
Jeffrey Heckman, DO 
JAHVH Physical Medicine and Rehabilitation Service 
813-972-2000 ext. 7506  
Jeffrey.t.heckman@va.gov 
VERSION NUMBER/DATE: 
_ v.6_07.06.23 
REVISION HISTORY 
*This table should only be used during submission of a Modification application to the IRB.  
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
v.2_05.17.22 
Adding non-Veterans to recruitment 
procedures 
yes 
2 
v.3_09.07.22 
Removing body powered prosthesis as an 
exclusion criteria 
no 
3 
v.4_10.24.22 
Changing PI to Jeffrey Heckman, DO; 
Clarifying that we request to bring clinical 
staff in addition to patients for fitting to 
JAHVH.  
yes 
4 
v.5_11.21.22 
Adding caregiver (if necessary) for travel 
yes 
5 
v.6_07.06.23 
Add activity tracker information; and add 
distribution of flyers to national amputee 
conference for recruitment. 
yes 
 
 

 
 
Page 2 of 18 
Revised: July 6, 2023  
 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 4 
3.0 
Background .............................................................................................................. 4 
4.0 
Safety Endpoints ...................................................................................................... 7 
5.0 
Study Interventions, Investigational Agents, and FDA-Regulated Products (as 
applicable) .......................................................................................................................... 8 
6.0 
Procedures Involved................................................................................................. 8 
7.0 
Data and Specimen Storage for Future Research .................................................. 12 
8.0 
Sharing of Results with Subjects ........................................................................... 12 
9.0 
Study Timelines ..................................................................................................... 12 
10.0 Inclusion and Exclusion Criteria ............................................................................ 12 
11.0 Vulnerable Populations .......................................................................................... 13 
12.0 Local Number of Subjects ..................................................................................... 13 
13.0 Recruitment Methods ............................................................................................. 13 
14.0 Withdrawal of Subjects .......................................................................................... 14 
15.0 Risks to Subjects .................................................................................................... 14 
16.0 Potential Benefits to Subjects or Others ................................................................ 14 
17.0 Data Management and Confidentiality .................................................................. 14 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 16 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 16 
20.0 Compensation for Research-Related Injury ........................................................... 16 
21.0 Subject Costs and Compensation ........................................................................... 16 
22.0 Consent Process ..................................................................................................... 17 
23.0 Setting .................................................................................................................... 18 
 
 

 
 
Page 3 of 18 
Revised: July 6, 2023  
 
1.0 
Study Summary  
 
1.1 Please provide a brief summary of the study in the table below. A complete 
description of the study with detailed information should be provided in the body of the 
protocol. For sections not applicable to the study, mark them as N/A. 
 
Study Title 
Brasthesis Prototype for Women Veterans with Upper Limb 
Amputations  
 
Study Design 
Prospective, Case series 
 
Primary 
Objective/Purpose 
To evaluate the satisfaction of and function and comfort with 
Brasthesis. 
 
Secondary 
Objective(s)/Purpose 
To compare Brasthesis to the amputee’s traditional harness. 
 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Use of a sports bra as a gender-specific harness for upper 
limb prostheses 
 
 
IND/IDE #  
N/A 
 
ClinicalTrials.gov 
NCT# 
Pending 
 
Study Population 
Women with a unilateral upper limb amputation 
 
Sample Size 
10  
 
Study Duration for 
individual subjects 
8 weeks (4 weeks for fitting and 4 week wearing period) 
 
Study Specific 
Abbreviations/ 
Definitions  
CPRS - Computerized Patient Record System 
FY – Fiscal Year 
HIPAA – Health Insurance Portability and Accountability 
Act 
IRB – Institutional Review Board 
JAHVH – James A. Haley Veterans’ Hospital 
PHI – Protected Health Information 
PI – Principal Investigator 
PM – Project Manager 
 
 

 
 
Page 4 of 18 
Revised: July 6, 2023  
 
2.0 
Objectives  
2.1 a. Evaluate the satisfaction of and function and comfort with Brasthesis. 
b. Use goniometry measures of range of motion and pressure mapping to compare 
range of motion and interface pressure of Brasthesis with the traditional harness. 
2.2  No hypotheses will be tested in this pilot proof-of-concept study. 
3.0 
Background 
3.1 Female Anatomy and Prosthetic Harness.  
              Limitations exist with the current traditional chest strap due to female anatomy. 
We know from the sports [1] and seat belt/airbag [2] literature that breast tissue injuries 
can disrupt the blood flow to the breast resulting in swelling, significant blood loss, 
hematoma, fat necrosis, and oil cyst hematoma. Injury to the mammary ducts can affect 
the future or current flow of breast milk [3]. More commonly, smaller superficial arteries 
along with veins become injured, leading to more localized injury and less serious 
bleeding and bruising. While there is no known research on whether a prosthetic harness 
can cause injury to breast tissue, we know that frequent wearing of tight clothing [4] can 
cause bruising, swelling, and thrombophlebitis. Further, regular physical activity is 
important in maintaining fitness, injury prevention, and overall well-being. Even without 
the additional pressure of a prosthetic harness, 50% of women report suffering exercise-
induced breast discomfort during exercise which leads to reduced physical activity 
participation [1].  
Both males and females with upper limb loss [5] report musculoskeletal pain, 
with no difference in reported pain between prosthetic wearers and non-wearers. Women 
with large breast sizes also report an increased prevalence and severity of 
musculoskeletal pain exacerbating the pain already caused by amputation(s), a problem 
exacerbated over the past decade as the mean bra size has increase from a 12B to a 14C; 
25% of bras sold are now a D cup or larger [6]. Age is an additional risk factor. 
Beginning about age 45, breast skin thickness decreases significantly [7]. Breast skin 
elasticity begins to decrease in the mid-twenties [7].  
Gender Comparisons. 
Satisfaction in Women with Limb loss (Non-Veteran). Most of the prosthetic 
satisfaction literature includes men and lower limb loss. In a sample of 362 participants 
with upper and lower limb trauma-related above elbow amputations (78% men) [8], 30% 
were dissatisfied with the comfort of their prosthesis. Women were less likely to be 
satisfied with fit, comfort and appearance [8]. Similarly, of 181 upper limb prosthesis 
wearers (86% men) [9], nearly 20% were dissatisfied with their prosthesis. Most used 
their prosthesis for about half of the tasks performed in everyday life [9].  
Rejection. In a study [9, 10] of 199 non-Veterans with upper limb loss (84% 
men), 25% of women and 11% of men discontinued wearing their upper limb prosthesis. 
The main reasons were dissatisfaction with comfort, function, and control. Discontinued 
use was more likely in more proximal amputations and in women [10]. In a second study 
[11] of 191 non-Veterans with upper limb loss (51% men), 31%, not stratified by gender, 
discontinued wearing their prosthesis. In both studies [9-11], 29% of the sample had an 
elbow or more proximal amputation. There are no known publications with women as the 
sole sample, although it is believed that this research is in progress.  

 
 
Page 5 of 18 
Revised: July 6, 2023  
 
A study [12] of 776 Veterans with upper limb loss (97% men) found that women 
were less likely to have ever used a prosthesis or received training in use of the 
prosthesis, more likely to use a cosmetic prosthesis, and less likely to use a body-powered 
prosthesis when compared to men. Device heaviness or fatigue was the most common 
reason for discontinued use. There were however only two women Veterans with 
forequarter or shoulder disarticulation enrolled in the study. Another study [13] of 196 
Veterans with upper limb loss (98% men) found 40% with transhumeral amputations and 
50% with shoulder disarticulations did not use a prosthesis. Prosthetic use was most 
frequently discontinued because of discomfort, pain, and weight of the device. 
A study [14] of 242 males and females with upper limb loss that included 68 
(28%) individuals with humeral amputation/shoulder disarticulation found that 80% of 
women with high-level amputations and 15% of men with high-level amputations 
discontinued use of their prosthesis. Ninety-five percent of participants reported comfort 
as a reason for discontinued use. In summary, we only have data for a few women with 
proximal upper limb amputations and disarticulations. The literature overall identifies 
comfort as a problem for women with upper limb amputations. 
Socket Fit.  
            The term ‘socket fit’ encompasses the factors that impact prosthetic comfort and 
stability on the residual limb [15]. Fit and associated comfort have a substantial effect on 
user satisfaction and prosthetic use [15]. The socket is the crucial junction where the soft 
tissue of the user's residual limb interfaces with the rigid materials of the prosthesis. 
Socket fit must, for our purposes, accommodate the female anatomy as well as position 
the prosthetic device to efficiently transmit intended movements [15]. Socket fit also 
includes appropriate distribution of pressure across the residual limb. While compression 
can increase mechanical stability, it can also cause discomfort, tissue irritation, and 
damage. This challenge is increased for individuals with proximal amputations as the 
weight of the prosthesis amplifies the demand of the socket and the residual limb [15]. 
We believe that Brasthesis may relieve uncomfortable pressure at the residual limb by 
increasing the contact area of the harness to include the sports bra. The Revolutionizing 
Prosthetics 2009 program [16] offered a solution similar to Brasthesis to the problem of 
the tightening around the intact shoulder required by the traditional harness  [16]. 
Recognizing that secure attachment to the body and distribution of weight are critical to 
comfortable fit and function, designed a shoulder-level socket with full fabric, tee shirt-
like suspension. 
Socket Pressure.  
           Accuracy and repeatability of the Tekscan F-Socket has been shown to be accurate 
with good reliability [17]. Daly et al. [18] were perhaps the first to use the pressure 
mapping with upper limb amputation research. No correlation was found between patient 
report of discomfort and pressure data. Schonfield et al. [15] built on the limitations of 
the Daly study to successfully characterize pressure distribution patterns unique to the 
participants socket designs. While using pressure mapping to better understand socket-fit 
is in its early stages, we believe that pressure mapping may be a useful tool to compare 
harness and socket pressure when wearing Brasthesis with the traditional prosthesis. 
We are not using pressure mapping to measure absolute values, rather, our focus is on 
how the harness distributes pressure and positions the socket on the residual limb and 

 
 
Page 6 of 18 
Revised: July 6, 2023  
 
thus influencing pressure distribution. Dr. Schonfield will provide expertise on pressure 
mapping on the proposed project 
 
3.2 Preliminary Prototype. We fit one non-Veteran patient with Brasthesis  during 
two Zoom sessions. The research team was in Tampa, Florida and the patient and 
prosthetic team in Texas. The patient had a short trans- humeral amputation, was two 
years post-trauma, and had five unsuccessful fittings including the Ottobock Active 
TH Harness, Figure 1a and 1b. The patient described the previous harnessing as “way 
too bulky and ugly. I tried to put clothes over it and I looked like a football player – I 
might as well put it over my clothes if I had to use the other one – it kind of defeats the 
purpose of trying to look normal.”  The patient’s prosthesis is a hybrid with a body 
powered elbow. The patient uses a lift assist incorporated into the body-powered elbow 
to ballistically move the elbow into flexion or she can bend forward at the waist and 
the elbow will move into flexion. Once she locks the elbow into the position she needs 
for function, she uses electromyographic (EMG) input from one muscle to open and 
close her myoelectric hand. Contraction of the muscle opens the hand and relaxation of 
that same muscle closes the hand. 
  
We fit the patient with Brasthesis in one session by adding two straps to the 
sports bra. We chose the Shefit sports bra because it provides a front closure and 
provides more support than other sport bras. Because we were unable to obtain the 
flexible yet strong fabric and strapping used in high end sports bras, we used two bras to 
fit one patient: one for the patient to wear and the other to deconstruct and reconstruct 
strapping to secure the prosthesis to the bra. Shefit donated bras for our prototype in the 
preliminary study. To fit Brasthesis, we cut two small d-rings (including fabric) from 
the second bra and attached one of these to the anterior portion of the socket and the other 
to the posterior portion of the socket using rivets. See Figures 2a-2d. All of the straps are 
removable from the socket of the prosthesis so that the bra can be washed. The patient 
described Brasthesis as “This feels great”, “It fits great under my shirt”, “I don’t feel 
like a football player”, “This bra is so comfortable and I can wear clothes over this”, “I 
love it”, and “Oh my gosh, I want to cry”. The patient wore Brasthesis home and has 
been using it regularly and successfully.  
The patient returned for a second session to adjust the front zipper closure for 
independent donning. We discovered during this fitting that strap placement will need to 
be individualized per women based on the presence and length of the residual limb and 
the available skin surface area that will be in contact with the prosthetic sensor. For this 
patient, post-surgery, the fascia of the deltoid and triceps muscles were used to facilitate 
coverage over the remainder of her humeral bone after amputation.  As a result, she has a 
large area of scarring that makes it difficult to find usable muscles for electromyographic 
(EMG) use to power her prosthesis. Thus, only one usable muscle site was identified and 
used for controlling the prosthesis. Her electrode needed to be secured in one particular 
area to avoid placing the electrode on half regular skin and half scarred skin emphasizing 
the importance of the right harnessing option to keep the socket in place for good 
activation of the prosthesis. Fitting this patient has made our design team appreciate how 
Brasthesis will need to be individualized for each woman. 
 
  
 

 
 
Page 7 of 18 
Revised: July 6, 2023  
 
References 
1. 
McGhee, D.E. and J.R. Steele, Breast Biomechanics: What Do We Really Know? 
Physiology (Bethesda), 2020. 35(2): p. 144-156. 
2. 
Majeski, J., Shoulder restraint injury of the female breast. Int Surg, 2007. 92(2): p. 99-
102. 
3. 
Sircar, T., et al., Seat-belt trauma of the breast in a pregnant woman causing milk-duct 
injury: a case report and review of the literature. Ann R Coll Surg Engl, 2010. 92(5): p. 
W14-5. 
4. 
Vincenza Polito, M., P. De Cicco, and R. Apicella, Tight Bra in a 34-Year-Old Woman: 
An Unusual Cause of Mondor's Disease. Ann Vasc Dis, 2014. 7(2): p. 149-51. 
5. 
Ostlie, K., et al., Musculoskeletal pain and overuse syndromes in adult acquired major 
upper-limb amputees. Arch Phys Med Rehabil, 2011. 92(12): p. 1967-1973 e1. 
6. 
McGhee, D.E., The story of . . .  the bra, in The Conversation. 2014, The Conversation, 
Inc.: Australia. 
7. 
Coltman, C.E., J.R. Steele, and D.E. McGhee, Effect of aging on breast skin thickness 
and elasticity: implications for breast support. Skin Res Technol, 2017. 23(3): p. 303-
311. 
8. 
Pezzin, L.E., et al., Use and satisfaction with prosthetic limb devices and related services. 
Arch Phys Med Rehabil, 2004. 85: p. 723-729. 
9. 
Ostlie, K., et al., Prosthesis use in adult acquired major upper-limb amputees: patterns of 
wear, prosthetic skills and the actual use of prostheses in activities of daily life. Disabil 
Rehabil Assist Technol, 2012. 7(6): p. 479-93. 
10. 
Ostlie, K., et al., Prosthesis rejection in acquired major upper-limb amputees: a 
population-based survey. Disabil Rehabil Assist Technol, 2012. 7(4): p. 294-303. 
11. 
Biddiss, E.A. and T.T. Chau, Multivariate prediction of upper limb prosthesis acceptance 
or rejection. Disabil Rehabil, 2008. 3(4): p. 181-192. 
12. 
Resnik, L.J., M.L. Borgia, and M.A. Clark, A National Survey of Prosthesis Use in 
Veterans with Major Upper Limb Amputation: Comparisons by Gender. PM R, 2020. 
12(11): p. 1086-1098. 
13. 
McFarland, L.V., et al., Unilateral upper-limb loss: satisfaction and prosthetic-device use 
in veterans and servicemembers from Vietnam and OIF/OEF conflicts. J Rehabil Res 
Dev, 2010. 47(4): p. 299-316. 
14. 
Biddiss, E. and T. Chau, Upper-limb prosthetics: critical factors in device abandonment. 
Am J Phys Med Rehabil, 2007. 86(12): p. 977-87. 
15. 
Schofield, J.S., et al., Characterization of interfacial socket pressure in transhumeral 
prostheses: A case series. PLoS One, 2017. 12(6): p. e0178517. 
16. 
Moran, C.W., Revolutionizing Prosthetics 2009 Modular Prosthetic Limb–Body 
Interface: Overview of the Prosthetic Socket Development. Johns Hopkins Applied 
Technical Digest, 2011. 30(3). 
17. 
Polliack, A.A., R.C. Sieh, and D.D. Crain, Scientific validation of two commercial 
pressure sensor systems for prosthetic socket fit. Prosthet Orthot Int, 2000. 24(1): p. 63-
73. 
18. 
Daly, W., et al., Socket pressure and discomfort in upperlimb prostheses: A preliminary 
study. Journal of Prosthetics and Orthotics, 2014. 26(2): p. 99-106. 
 
4.0 
Safety Endpoints  
4.1  Primary endpoints are satisfaction, function, and comfort. 
       The secondary endpoints are the interface pressure that drives comfort and range of 
motion that drive functional movement. 

 
 
Page 8 of 18 
Revised: July 6, 2023  
 
5.0 
Study Interventions, Investigational Agents, and FDA-Regulated 
Products (as applicable) 
5.1 The study intervention is our patent-pending harness that we have named ‘Brasthesis’ 
for women amputees. The patent was submitted 12/6/2021. Brasthesis adapts a heavy-
duty sports bra to replace commercially available prosthetic harnesses. See photos of 
commercially available, top, and Brasthesis below. 
5.2 Drug/Device Handling: N/A. While a prosthesis is considered a device, the harness 
attaching the prosthesis to the residual limb is not considered device. 
 
 
 
 
 
 
5.3 N/A.  
5.4 N/A.  
5.5 N/A.  
6.0 
Procedures Involved 
6.1 
This project will use a case series design to fit five women with unilateral 
upper limb loss with Brasthesis (harness). The proposed project will offer three 
fitting options: (1) We will fit patients face to face at the James A Haley VA 
Hospital (JAHVH), (2) We have requested travel funds to bring patients, caregiver 
(if necessary), and clinical staff to JAHVH for fitting, an option we found 
successful with previous prosthetic arm studies, and (3) We will use a VA 
Devices 
Drugs/Biologics 
☐ FDA Approved Device – Approved Use 
☐ FDA Approved Drug/Biologic – Approved 
Use 
☐ FDA Approved Device – Unapproved Use ☐ FDA Approved Drug/Biologic – 
Unapproved Use 
☐ Investigational Device – Non-Significant 
Risk 
☐ Investigational Drug/Biologics 
☐ Investigational Device – Significant Risk 
☐ Placebo 
☐ Humanitarian Use Device Exemption 
☐ Other Drugs/Biologics 
☐ Other Devices 
 

 
 
Page 9 of 18 
Revised: July 6, 2023  
 
approved video conferencing system/software, e.g., Veteran Video Connect, with 
the research team at one location and the patient and patient’s prosthetic team at a 
second location (as we did for our prototype during the COVID-19 restrictions). 
Option 3 will only be used if we have difficulty recruiting with options 1 and 2. 
6.2 
Outcomes data will be collected via survey and brief interview. Pressure 
mapping and range of motion data will be collected using pressure mapping 
technology and a goniometer. One focus group will be held after all patients have 
been fitted. All data will be analyzed descriptively. Subjects will be given the 
option to consent to having photos taken post intervention for educational and/or 
technology development purposes. 
6.2  
• At baseline, after signing of informed consent, the project manager will work with 
the participant over the phone to order two bras from the Shefit® website, using 
sizing provided on the website. One Shefit® bra will be for the participant to wear 
and the other bra will be deconstructed for strapping and d-rings.  
• During this baseline phone meeting, the project manager will ask how many days 
per week and hours per day the participant wears their prosthesis with traditional 
harness. The project manager will explain, as delineated in the informed consent 
document, that she will contact the participant weekly during the four-week wear 
period for the purpose of checking in, i.e., checking on Brasthesis wearing time 
and problems that may have occurred during the week.  
• During this baseline phone meeting, the two sub-surveys of the Orthotic and 
Prosthetic User Survey (OPUS) and the one-item Socket Comfort Scale will be 
administered.  The socket comfort scale is a one-item analog 0-10 self report 
rating scale.  There is no published pdf for this one-item scale.  The score is 
included in the Data Collection Sheet Item #12.  
• The project manager will extract demographic and clinical information from the 
medical record. 
☒Audio/Video Recording 
☐Physical Exam 
☐Blinding 
☐Radiation or Radiation-Producing 
Machines (e.g. X-ray, CT, etc.) 
☐Control Group 
☐Radioactive Materials (e.g. 
Radiopharmaceuticals) 
☐Deception 
☐Randomization  
☒Focus Groups 
☒Record, Chart, or Dataset Review  
☒Follow-Up Call 
☐Specimen Analysis 
☒Interviews 
☐Specimen Collection 
☐New Innovative Practice/Therapy 
☒Surveys and/or Questionnaires 
☐New Investigational Procedure (e.g. a new 
surgical procedure)  
☐Other Biomedical Procedures  

 
 
Page 10 of 18 
Revised: July 6, 2023  
 
• The participant will be scheduled for a fitting at a prosthetic clinic, either 
at the JAHVH study site or their home VA prosthetic clinic, the clinic 
regularly attend in/ near their place of residence. The fitting process will 
begin with introductions. The participant will don the 
prosthesis/traditional harness. We measure functional range of motion 
(shoulder flexion/extension and abduction/adduction) with a goniometer 
while participants are wearing their conventional prosthetic harness. 
• Also at the fitting visit, we will use the Tekscan Artec Studio system to quantify 
pressure between the prosthetic socket and residual limb and around the 
contralateral axilla while wearing the traditional harness. Pressure mapping entails 
attaching a paper thin, flexible sensor, trimmed to match anatomical contours with 
double sided adhesive tape directly to the skin to securely cover each participant’s 
residual limb and in the contralateral axilla region then mapping pressure at three 
positions: (1) prepressure will be measured wearing the prosthetic liner with the 
residual limb positioned neutral at their side, (2) wearing prosthesis with 90 
degrees prosthetic elbow flexion, and (3) full elbow extension with shoulder 
flexion in the plane of the scapula [5].  
• The subject will then don the Shefit® bra over the traditional harness. We 
will mark where the traditional harness and Shefit® overlap. D-rings from 
the spare bra will be riveted at the marked spots (for our prototype, the 
patient required two d-rings anterior and posterior). Once the d-rings have 
been riveted to the prosthesis, the participant will don modified Shefit 
bra/Brasthesis. At this point the custom fitting will begin which will vary 
from participant to participant. Our prototype patient had gaping at the top 
of the socket that was successfully addressed by adding a strap from the 
spare bra cross the participant’s back. The participant guided the 
prosthetist as to where she needed support. The prosthetist riveted a third 
central d-ring to accommodate a diagonal backstrap. This 
individualization may vary for each of the five subjects and is the primary 
purpose for this proof of concept study. 
• We will replace the front zipper with a commercially available magnetic 
bra closure for one-handed donning, if desired 
• Participants will be provided a Jawbone UP 24 or OPOS1 activity tracker by the 
prosthetist once the prosthesis has been successfully fit using Brasthesis. Jawbone 
API software or OPOS1 software provides direct export of accelerometer that 
contains no PHI or PII (deidentified) data to approximate wear time to the hour of 
each day.  
• The prosthetic and research teams will be available should the participant need 
adjustment to the harness and prosthetic fit, per standard care. 
• At the end of the four-week wearing period, the participant will return to the 
clinic. Range of motion measurement and pressure mapping will be repeated but 
this time with the Brasthesis rather than the traditional harness.    

 
 
Page 11 of 18 
Revised: July 6, 2023  
 
• The outcome measures administered at baseline will be completed again post-
intervention. The project manager will conduct a brief interview for the 
participant and prosthetic team to understand the experience of being fit with and 
using Brasthesis. This interview will be audio recorded. 
• The participant will be told that after all five participants have completed 
Brasthesis, a focus group will be held for the purpose of brainstorming how to 
proceed with the manufacturing and marketing of Brasthesis. This focus group 
will be audio recorded. 
6.3 All procedures will be performed solely for research purposes except for the 
prosthetic clinic visits for Brasthesis and prosthetic adjustment as needed. Returning to 
the amputation clinic for Brasthesis/harness or prosthetic adjustment are standard care. 
6.4 Participants will be under the care of experience amputee and prosthetic clinicians 
including occupational therapists, physicians, prosthetists, and engineers who will be able 
to efficiently and empathetically address any challenge that may occur during the 
Brasthesis fitting process and wearing period. 
Participants can return to the use of their traditional harness at any time. They will not be 
withdrawn from the study if they return to using their traditional harness as data on why 
participants use or do not use Brasthesis are needed to address research questions. 
Participants can contact the project manager, an occupational therapist with extensive 
upper limb amputation and prosthetic experience, at any time. 
6.5 Aim one of this project will capture existing data:  
• Data to be collected is displayed in the Table below and the uploaded data capture 
sheet. 
Table 1  Variables 
Variable 
RQ 
Definition 
Source, Timepoint 
Outcomes 
Wearing time 
1.1 
Days/week, hours/day,  
Traditional versus Brasthesis 
Weekly communication 
Jawbone Up 24 or OPOS1 activity tracker 
Automated 
Satisfaction 
1.2 
OPUS Satisfaction with Device  
Traditional – pre 
Brasthesis - post 
Function 
1.3 
OPUS UE Functional Status [22] (Appendix 
5) 
Comfort 
1.4 
Socket Comfort Score [23], 0-10 numeric 
rating scale 
Barriers 
1.5 
Described by participants and clinicians 
Post interview (QL) 
Pressure 
2.1,2.2 
Tekscan F-Socket (Appendix 7) 
Prosthetist, engineer, post  
Demographic and Clinical Variables 
Age 
All 
Age on date of baseline data collection 
CPRS, baseline interview 
Sex 
Male, female, other 
Race/ethnicity 
Caucasian, African American, Hispanic, 
Time since 
In years: index event – date at baseline 
Amputation 
transhumeral, shoulder, interscalulothoracic 

 
 
Page 12 of 18 
Revised: July 6, 2023  
 
 
6.6 No biological specimens will be collected. 
6.7 The only semi-long-term follow-up will be the focus group once all five participants 
have completed the 4-week wearing period. The focus group will be audio recorded using 
the TEAMS recording feature. Once transcribed, the audio recording will be destroyed. 
6.8 No Humanitarian Use Devices (HUD). 
7.0 
Data and Specimen Storage for Future Research 
7.1 No data or specimens will be banked for future use.  
7.2 N/A 
7.3 N/A 
8.0 
Sharing of Results with Subjects 
8.1 Study results will be shared with subjects and subject’s primary care physicians upon 
request. Shared data will be encrypted and will remain behind the VA firewall.  
9.0 
Study Timelines 
9.1 It should take up to 2-4 weeks to fit Brasthesis (one to three prosthetic clinic visits). 
The Brasthesis wearing period is 4-weeks. Data collection could add a week before and a 
week after the wearing period depending on scheduling. 
9.2 The entire project will take one to two years including dissemination of findings. 
 
10.0 Inclusion and Exclusion Criteria 
10.1 Potential subject will self-identify with the project manager whether they meet the 
inclusion criteria. Inclusion and exclusion criteria are observable. 
10.2 The inclusion criteria are: (1) mid to short transhumeral, shoulder, or 
interscapularthoracic unilateral amputation, (2) have an existing myoelectric, hybrid, 
body-powered or cosmetic prosthetic limb that they use or have abandoned. The 
additional resources to train a participant with no prosthetic experience is beyond the 
scope of this study.  
10.3 The exclusion criteria: (1) open wounds in the upper torso or extremities, (2) women 
who do not have an existing prosthesis would exceed the time resources for a SPIRE 
funding mechanism.  
Prosthesis 
type 
Myoelectric, hybrid, cosmetic 
 
Bra size 
Size of She-fit bra ordered 
OPUS=Orthotics and Prosthetics User’s Survey, UE=upper extremity, QL=qualitative, 
CPRS=Computerized Patient Record System 

 
 
Page 13 of 18 
Revised: July 6, 2023  
 
10.4 A subject will be ineligible to continue participation if they develop a condition on 
their residual body part that disallows them to wear a prosthesis, such as a bone spur or 
open sore. 
10.5 No students, employees, socially and/or economically disadvantaged, or wards of 
the state will be included. 
11.0 Vulnerable Populations 
11.1 No vulnerable populations will be included. 
12.0 Local Number of Subjects 
12.1 We will recruit up to 10 subjects.  
12.2 Five subjects are needed to complete the research.  
13.0 Recruitment Methods 
13.1 
We are proposing three recruitment paths to be initiated at the beginning 
of the project. The first path is to recruit through our current prosthetic patients and 
those of our prosthetic research colleagues in VISNs 2 and 20. Second, the Director 
of our Regional Amputation Center, PI Heckman, will present the study at a 
regularly scheduled National Amputation System of Care meeting. The Amputation 
System of Care network will provide a point of contact at each site to receive an 
email from the study project manager with a pertinent study description and contact 
information for women Veterans interested in the study. An IRB-approved study 
flyer with study contact information will be distributed electronically to all 
recruitment sites and will be included in the approach letters. The third path is to 
send approach letters to women Veterans with upper limb loss, identified in the VA 
Amputation Cube, following VA HIPAA policy. Patients will be identified by sex, 
upper limb unilateral limb loss, and elbow and above disarticulation/ amputation.  
A list will be generated of the patients meeting these criteria. 
If we cannot identify and consent five female Veteran amputees, we will recruit 
non-Veteran female amputees by dispersing IRB approved flyer to prosthetist 
colleagues.  We will distribute IRB approved flyers at a national amputee 
conference. Non-Veterans may be required for this study because female upper 
extremity amputees are a small portion of the general population.  Therefore, we 
may require non-Veterans to meet our enrollment goal. Veterans will be given 
preference.  Non-Veterans will be used if we are unable to meet enrollment goals.   
13.2 
• Flyer and approach letters uploaded.  
13.3 N/A. Special and vulnerable populations not recruited. 
☐ Email 
☐ Online/Social Media Advertisement 
☒ Flyer 
☒ Record Review 
☒ Letter 
☐ Other 
☐ News Advertisement 
 

 
 
Page 14 of 18 
Revised: July 6, 2023  
 
14.0 Withdrawal of Subjects 
14.1 A subject may be withdrawn or preferably partially withdrawn from the research 
without their consent if they develop a condition on their residual body part that disallows 
them to wear a prosthesis, such as a bone spur or open sore. 
14.2 The decision to withdraw will be made between the patient and the study physician. 
14.3 Partial withdrawal is an option where the subject will discontinue wearing 
Brasthesis but will continue with the interview and focus group participation.  
15.0 Risks to Subjects 
15.1 
Based on our preliminary prototypes, the intervention should be more comfortable 
than standard care. To date, no physical risks associated with wearing a prosthetic 
harness have been published.  
Many upper limb amputees have rejected their prostheses due to discomfort or difficulty 
using the prosthesis. Women amputees who have abandon their previous are eligible to 
enroll in this research. There is a risk that they will experience the discomfort and 
learning challenges again.  
All research has inherent risks to privacy and/or confidentiality. 
15.2 There are no risks to an embryo or fetus should the subject be or become pregnant. 
15.3 There are no risks to others who are not subjects. 
16.0 Potential Benefits to Subjects or Others 
16.1 Individual subjects may experience increased comfort and function when using the 
Brasthesis harness as compared to the traditional harness, which in turn can increase 
function.                  
16.2 The study has the potential to offer women with an amputation a more comfortable, 
less expensive prosthetic harness option. 
17.0 Data Management and Confidentiality 
17.1 Because there will be only five subjects, descriptive analyses will be used. 
17.2 All data will be stored electronically on the backed-up and protected JAHVH S-
drive/Research/R drive Research/PROJECTS CURRENT/Winkler Team/Brasthesis. 
There will be no paper data. All staff will be current on their privacy training. Identifiable 
data will be stored separately from informed consent documents and the crosswalk file. 
Only authorized team members (PI, project manager) will have access to protected data 
and documents. All data will remain at the JAHVH in the research protected environment 
for analysis. Access will be terminated for personnel who are no longer part of the 
research team. The project manager and PI will monitor compliance and to ensure that 
the HIPAA, IRB, and VA rules and regulations are being followed and met. The PI will 
be responsible for all incident reporting to the IRB and R&D Committee, ISSO and 
Privacy officer as appropriate.   

 
 
Page 15 of 18 
Revised: July 6, 2023  
 
17.3 Procedures that will be used to ensure the accuracy and quality of collected data 
include: 
• Discussion of data at twice monthly research team meetings 
• A single person collecting and entering data 
• Opportunities exist to collect missing data 
17.4 Handling data study-wide:  
• See Table 1 in 6.5 for data collected. Identifiable information includes names, 
date of birth, telephone number, email address, medical record number 
(lastname+last 4 of SSN), and voice recording.  
• Data will be stored per current VA policy RCS-10. 
• Data will be destroyed per VA policy RCS-10. 
• Confidential data will not be shared with anyone outside of the research group.  
17.5 
  
• No PHI will be disclosed or received from individuals outside of the research 
group. 
• For our requested waiver:  
o Data will be acquired from the VHA Proclarity Analytics Server 
Amputation Cube (for the approach letters for recruiting purposes). 
o Inclusion criteria: VISN, Facility, FY, Upper Limb, Female, Amputation 
level 
o FY 2012 – FY 2022 
o Only the PI and the project manager will have access to identifiers which 
will be located in a password protected file in the research project folder 
on the protected JAHVH research S-drive.  
o For potential subjects who enroll, their name will be added to the 
crosswalk file that will be stored with the informed consent documents 
and separate from data. Data for potential subjects who decline to enroll 
will be destroyed immediately per VA policy. Data for potential subjects 
who cannot be contacted will be destroyed at six months into the study per 
VA policy, providing a 6-month response period. 
☐Obtaining Signed Authorization 
☒Waiver of HIPAA Authorization for 
Recruitment/Screening Purposes Only 
☐Obtaining Online or Verbal Authorization 
(Alteration of HIPAA Authorization) 
☐Data Use Agreement 
☐Waiver of HIPAA Authorization for Entire 
Study 
☐Business Associate Agreement 

 
 
Page 16 of 18 
Revised: July 6, 2023  
 
o PHI will not be reused/disclosed to any other person or entity except as 
required by law, for authorized oversight of the research project, or for 
other research which use/disclosure of PHI would be permitted by the 
HIPAA privacy regulations. 
o It is not practicable to obtain signed HIPAA Authorizations from the 
subjects before using their PHI because we are going back 10 years in the 
records. We anticipate that we will not have current contact information 
for many of the potential subjects. It is not practicable as not all subjects 
will be eligible. Signed authorization will be obtained from subjects who 
are eligible and agree to participate. 
o The study cannot be conducted without access to and use of subjects’ PHI 
because we may not have a large enough sample size to successfully 
complete the study. We need access to PHI to verify eligibility. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
18.1 The surveys/questionnaires/interview/focus groups will ask questions about 
satisfaction with and comfort of a new and traditional prosthetic harnesses and function 
skills. The study is not enrolling new amputees who have never been fitted for a 
prosthesis. We do not anticipate that these questions will be unsettling but should a 
subject need counseling or other assistance, the study will be completed in a medical 
environment with a physician specializing in amputation on the team. Resources will be 
readily available for counseling or other assistance referrals.  
18.2 N/A. This research does not involve more than minimal risk to subjects. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subjects will be interacting with the research and clinical teams, both comprised of 
licensed clinicians (physiatry, prosthetics, occupational therapy). The clinical team is the 
subjects standard care team. The research team is at the JAHVH. Should a subject not 
want to interact with one of the research team members, the situation will be discussed at 
a research team meeting. It may be necessary to unenroll the subject. Limits placed on to 
whom the subjects provide personal information will be honored. The licensed 
occupational therapist program manager who will be collecting data has extensive 
amputation, prosthetic, and research experience and has regularly received VA 
recognition for her empathy with Veterans.  
19.2 The research team is permitted to access any sources of information about the 
subjects because they are VA employees. 
20.0 Compensation for Research-Related Injury 
20.1 N/A. The research does not involve more than minimal risk to subjects. 
21.0 Subject Costs and Compensation 
21.1 The only cost that will be incurred is travel to the VA. We are able to reimburse 
travel expenses (mileage, airfare, meals, hotel, etc.) for the subject and caregiver (if 
necessary). The Brasthesis harness will be provided at no cost to the subject. 

 
 
Page 17 of 18 
Revised: July 6, 2023  
 
21.2 Other than travel, no payments will be made to subjects. 
22.3 The VA Medical Center is not responsible for any research-related injury treatment 
costs of a non-Veteran. The non-Veteran and his or her insurance or third-party payer 
cannot be a responsible party. 
 
22.0 Consent Process 
22.1  
 
22.2  Informed consent process: 
• The consent process will most likely take place over the phone. Potential subjects 
will contact the project manager who will answer questions and mail a blank 
informed consent for review. The potential subject will have up to one week to 
sign the consent and return the project manager in the provided addressed and 
postage paid envelop. 
• If the potential subject has not responded within two weeks of mailing the blank 
consent document, the project manager will call the potential subject to answer 
further questions. 
o The project manager and the PI will be involved in the consent process.  
o There will be no limit on the time devoted to the consent discussion. 
o The informed consent document itself and the person obtaining informed 
consent will explain that participation is voluntary and that they have the 
option of trying the Brasthesis harness or continuing to use their 
traditional harness.  
o The project manager obtaining informed consent is a licensed clinician 
with years of experience treating patients, responding empathetically, 
reading body language, creating an environment where patients feel safe 
to ask questions. 
22.3 N/A. We will not be obtaining consent online or verbally. 
22.4 Justification was provided in 17.5. 
22.5 N/A. We will not be obtaining consent from non-English speaking subjects. 
22.6 N/A. We will not enroll individuals who have not attained the legal age for consent. 
☒Obtaining Signed Consent (Subject or 
Legally Authorized Representative) 
☐Obtaining Consent Online (Waiver of Written 
Documentation of Consent) 
☐Obtaining Signed Parental Permission 
☐Obtaining Verbal Consent (Waiver of Written 
Documentation of Consent) 
☐Obtaining Signed Assent for Children 
or Adults Unable to Consent 
☒Waiving Consent and/or Parental Permission 
(Waiver of Consent Process -
RECRUITMENT ONLY) 
☐Obtaining Verbal Assent for Children or 
Adults Unable to Consent 
☐Waiving Assent/Assent is Not Appropriate 

 
 
Page 18 of 18 
Revised: July 6, 2023  
 
22.7 N/A. Project does not involve HUD. 
23.0 Setting 
23.1  All research procedures will be performed at the JAHVH. Fitting of the Brasthesis 
harness may take place at other VA facilities via VideoConnect with the JAHVH-based 
research team and the subjects’ home clinical team.