Brasthesis Prosthetic Harness for Arm Amputation (Brasthesis Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJeffrey T Heckman, DO
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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
James A. Haley Veterans' Hospital, Tampa, FLTampa, FL
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor