Brasthesis Prototype for Women Veterans with Upper Limb Amputations

NIH RePORTER · VA · I21 · · view on reporter.nih.gov ↗

Abstract

Current traditional prosthetic chest harnessing worn by women Veterans with limb loss) is less than optimal 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. We have designed a bra with incorporated prosthetic harness prototype for women Veterans with mid to short transhumeral, shoulder, or interscapulothoracic amputation(s) that we 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 we used for constructing our 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. We 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). We 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 con...

Key facts

NIH application ID
11044975
Project number
5I21RX003851-03
Recipient
JAMES A. HALEY VA MEDICAL CENTER
Principal Investigator
Jeffrey T. Heckman
Activity code
I21
Funding institute
VA
Fiscal year
2024
Award amount
Award type
5
Project period
2022-04-01 → 2024-09-30