Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations

Upper Limb Amputation Clinical Trial

— Brasthesis  

Official title:

Brasthesis Prototype for Women Veterans With Upper Limb Amputations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179395
• Other study ID #: A3851-P
• Secondary ID: I21RX003851-01A1
• Status: Completed
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. One woman who was unable to wear a traditional prosthesis reported that Brasthesis was comfortable and that she was able to wear her clothes over Brasthesis without feeling like a football player. 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. Brasthesis will be inexpensive so that Veterans can have more than one in a variety of colors. Brasthesis is machine washable.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• mid to short transhumeral, shoulder, or interscapularthoracic unilateral amputation,

• have an existing myoelectric, hybrid, 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.

Exclusion Criteria:

• open wounds in the upper torso or extremities,

• body-powered prosthetic users are excluded due to the dynamic requirements of the harness. The investigators decided including women who did not have an existing prosthesis would exceed the time resources for a SPIRE funding mechanism.

Related Conditions & MeSH terms

• Upper Limb Amputation

Intervention

Other:
• Brasthesis
Brasthesis is a harness that is integrated with an off the shelf sports bra

Locations

Country	Name	City	State
United States	James A. Haley Veterans' Hospital, Tampa, FL	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	activity tracker	The activity tracker will automatically track prosthesis/harness wearing time	During 4-week time period
Primary	Change in Prosthetic Function and Satisfaction using the Orthotic and Prosthetic Users Survey (OPUS)	The OPUS self-report survey consisting of five modules. Two of the modules will be used to measure change: The Upper Extremity Functional Status Survey and Satisfaction with Devices - when wearing a traditional and Brasthesis harness.; The 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. The 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. 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.	Pre and post 4-week harness wearing time
Primary	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.	Pre and post 4-week harness wearing time
Secondary	Change in Range of Motion	Change in range of motion of the residual limb will be measured using a goniometer.	Pre and post 4-week harness wearing time
Secondary	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).	Pre and post 4-week harness wearing time