N/A
N=5
Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations
Upper Limb Amputation
Bottom Line
View on ClinicalTrials.gov: NCT05179395 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS) — 73 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brasthesis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS) |
73 | — |
| PRIMARY Change in Comfort Measures With the Socket Comfort Score |
4.75 | — |
| PRIMARY Satisfaction With Devices |
41.25 | — |
| SECONDARY Change in Range of Motion |
103; 39; 0; 100 | — |
| SECONDARY Change in Pressure Using the Tekscan F-Socket Pressure Mapping System |
92 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- mid to short transhumeral, shoulder, or interscapulothoracic 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.
Data sourced from ClinicalTrials.gov (NCT05179395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.