Brasthesis Prosthetic Harness for Arm Amputation (Brasthesis Trial)

Recruiting in Palo Alto (17 mi)

Overseen BySandra L. Winkler, PhD MA BS

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests Brasthesis, a sports bra designed for women Veterans who have lost an upper limb. The bra includes special straps to hold a prosthetic arm comfortably and securely. It aims to improve comfort and reduce potential injuries compared to traditional prosthetic harnesses.

Eligibility Criteria

This trial is for women veterans who have lost an upper limb (mid to short transhumeral, shoulder, or interscapularthoracic amputation) and currently use or have stopped using a myoelectric, hybrid, or cosmetic prosthetic limb. It's not suitable for those with body-powered prosthetics, without any prosthesis experience, or with open wounds in the upper torso/extremities.

Inclusion Criteria

I have an amputation above the elbow, at the shoulder, or between the shoulder blades.

Exclusion Criteria

I have open wounds on my upper body or arms/legs.

Participant Groups

The study tests Brasthesis—a new type of sports bra that integrates harnessing straps for holding a prosthesis. It aims to provide comfort and better positioning of the prosthetic sensor against the residual limb. The product will be customizable and machine washable.

1Treatment groups

Experimental Treatment

Group I: BrasthesisExperimental Treatment1 Intervention

All five participants will wear Brasthesis for 4-weeks