An interventional study of Brasthesis in Upper Limb Amputation, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Device feasibility
This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra. The position of the harnessing straps are individualized for each woman so that the prosthesis can be positioned for optimal contact between the prosthetic sensor and the residual limb. The investigators foresee Brasthesis being available as an adaptable sports bra that comes with a goodie bag of spare parts that can be used to customize Brasthesis. The investigators plan to develop Brasthesis to be machine washable and relatively inexpensive so that Veterans can have more than one in a variety of colors.
Current traditional prosthetic chest harnessing worn by women Veterans with limb loss) is less than optimal due to female anatomy. The investigators know from the sports and seat belt/airbag 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. 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, the investigators know that frequent wearing of tight clothing can cause bruising, swelling, and thrombophlebitis. The investigators have designed a bra with incorporated prosthetic harness prototype for women Veterans with mid to short transhumeral, shoulder, or interscapulothoracic amputation(s) that the investigators have named Brasthesis (patent pending). The purpose of the proposed project is to use a case series design to prove the concept of Brasthesis prototype. The specific aims of this project are to: (1) Compare the satisfaction and function with and comfort of Brasthesis with the traditional harness and (2) Use pressure mapping to compare the interface pressure of Brasthesis with the traditional prosthesis. Five women with proximal upper limb loss will be fit with Brasthesis using a procedure similar to the one the investigators used for constructing the prototype. The inclusion criteria are: (1) unilateral mid to short trans-humeral, shoulder, or interscapular-thoracic unilateral amputation and (2) have an existing myoelectric or hybrid prosthetic limb that they used or rejected/abandoned. The additional resources required to train a participant with no prosthetic experience is judged beyond SPIRE resources/scope of this study. The exclusion criteria are: (1) open wounds in the upper torso or extremities and (2) body-powered prosthetic users due to the dynamic requirements of the harness. The investigators will pursue Using Brasthesis with body powered prosthetics in a subsequent study. Once the patient has provided written informed consent, two bras will be ordered. One bra the patient will wear. The second bra will be deconstructed and reconstructed for individualized suspensory harness strapping. At the time of Brasthesis fitting, baseline will be collected, demographic and clinical data and satisfaction, function, and comfort outcomes measures. After fitting, the participant will wear Brasthesis for four weeks. Participants will be contacted weekly to track wearing time in days per week and hours per day (Aim 1). The investigators will also employ a Jawbone Up 24 activity tracker as a quantitative proxy of prosthesis wear time. Pre to post ordinal change in wearing time, satisfaction, function, and comfort outcomes will be analyzed using quantitative descriptive analyses. At the end of the wearing period, PI Winkler will conduct semi-structured phone interviews with participants and the prosthetist. Interviews will be transcribed and analyzed using thematic analysis guided by descriptive phenomenology theory. The semi-structured interview will have three overall discussion points: (1) Describe the barriers encountered while fitting Brasthesis , (2) How did you manage strap placement based on the presence and length of the residual limb and the available skin surface area available for contact with the prosthetic sensor, and (3) How does Brasthesis compare with traditional prosthesis? Aim 2 will use pressure mapping technology to compare the residual limb and intact limb under arm pressure distribution data for Brasthesis and participants' traditional prostheses. The investigators will create color-coded 'heat maps' that directly link pressure values to the three-dimensional anatomy of each participant.
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Exclusion Criteria:
All five participants will wear Brasthesis for 4-weeks
Device: Brasthesis
Brasthesis is a harness that is integrated with an off the shelf sports bra
Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS)
One of the OPUS self-report survey modules is the Upper Extremity Functional Status Survey which will be used to measure change: The Upper Extremity Functional Status Survey- when wearing a traditional and Brasthesis harness. 1. The Upper Extremity Functional Status Survey has 28 items that are rated on a 5-point Likert type scale with a a possible range from 0 to 112 with a higher score representing a higher level of independent function.
Time frame: Pre and post 4-week harness wearing time
Change in Comfort Measures With the Socket Comfort Score
The change in comfort will be measured between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post). The Socket Comfort Score is a 1-item measure that rates comfort on a 11-point Likert-type scale with a range of 0-10. A higher score indicates more comfort.
Time frame: Pre and post 4-week harness wearing time
Satisfaction With Devices
The Satisfaction with Device Survey has 11 items that are rated on a 5-point Likert type scale with a a possible range from 11 to 55 with a higher score representing a better outcome, e.g., more satisfaction.
Time frame: At post 4 week harness wearing time
Change in Range of Motion
Change in range of motion of the residual limb will be measured using a goniometer. Normal values for shoulder flexion range from 0-180 Normal values for shoulder extension range from 0-60 Normal values for shoulder adduction range from 0-50 Normal values for shoulder abduction range from 0-180
Time frame: Pre and post 4-week harness wearing time
Change in Pressure Using the Tekscan F-Socket Pressure Mapping System
The change in pressure between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post). Data reported as mean max pressure mmHg Normal range of pressure readings are 0-250 mmHg
Time frame: Pre and post 4-week harness wearing time
Activity Tracker
The activity tracker measures prosthesis/harness wearing time and reports in 15 minute increments of time. Wearing time was summed to a calculation of hours per week across the 4 weeks of the study period. The range of hours per week is 0-168.
Time frame: 4 week time frame from baseline to follow up
| Milestone | Brasthesis |
|---|---|
| Started | 5 |
| Participants enrolled | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Lack of efficacy | 1 |
One of the OPUS self-report survey modules is the Upper Extremity Functional Status Survey which will be used to measure change: The Upper Extremity Functional Status Survey- when wearing a traditional and Brasthesis harness. 1. The Upper Extremity Functional Status Survey has 28 items that are rated on a 5-point Likert type scale with a a possible range from 0 to 112 with a higher score representing a higher level of independent function.
| Units on a scale | Brasthesis |
|---|---|
| Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS) | 73 ± 2.9 |
The change in comfort will be measured between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post). The Socket Comfort Score is a 1-item measure that rates comfort on a 11-point Likert-type scale with a range of 0-10. A higher score indicates more comfort.
| score on a scale | Brasthesis |
|---|---|
| Change in Comfort Measures With the Socket Comfort Score | 4.75 ± 1.25 |
The Satisfaction with Device Survey has 11 items that are rated on a 5-point Likert type scale with a a possible range from 11 to 55 with a higher score representing a better outcome, e.g., more satisfaction.
| units on a scale | Brasthesis |
|---|---|
| Satisfaction With Devices | 41.25 ± 5.8 |
Change in range of motion of the residual limb will be measured using a goniometer. Normal values for shoulder flexion range from 0-180 Normal values for shoulder extension range from 0-60 Normal values for shoulder adduction range from 0-50 Normal values for shoulder abduction range from 0-180
| Degrees | Brasthesis |
|---|---|
| Change in ROM in shoulder flexion | 103 ± 56 |
| Change in ROM in shoulder extension | 39 ± 18 |
| Change in ROM in shoulder adduction | 0 ± 0 |
| Change in ROM in shoulder abduction | 100 ± 53 |
The change in pressure between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post). Data reported as mean max pressure mmHg Normal range of pressure readings are 0-250 mmHg
| mmHg | Brasthesis |
|---|---|
| Change in Pressure Using the Tekscan F-Socket Pressure Mapping System | 92 ± 10 |
The activity tracker measures prosthesis/harness wearing time and reports in 15 minute increments of time. Wearing time was summed to a calculation of hours per week across the 4 weeks of the study period. The range of hours per week is 0-168.
| Hours per week | Brasthesis |
|---|---|
| Activity Tracker | 43.75 ± 32.85 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brasthesis | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Brasthesis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Age, Continuous(years) | Brasthesis |
|---|---|
| Mean | 49.8 ± 10.3 |
| Sex: Female, Male(Participants) | Brasthesis |
|---|---|
| Female | 5 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Brasthesis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Brasthesis |
|---|---|
| United States | 5 |
| Socket Comfort Score(units on a scale) | Brasthesis |
|---|---|
| Mean | 4.8 ± 1.1 |
| Wear Time(hours per week) | Brasthesis |
|---|---|
| Mean | 32 ± 24.7 |
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