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Prosthetic Harness

Brasthesis Prosthetic Harness for Arm Amputation (Brasthesis Trial)

N/A
Waitlist Available
Led By Jeffrey T Heckman, DO
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
mid to short transhumeral, shoulder, or interscapularthoracic unilateral amputation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during 4-week time period
Awards & highlights

Brasthesis Trial Summary

This trial is testing Brasthesis, a new product for women Veterans with upper limb loss that is adaptable to each individual. The aim is to make it more comfortable and practical for everyday use.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not mentioned in this summary, potential issues may include discomfort from improper fitting or skin irritation due to material sensitivity. However, one participant reported comfortable use under regular clothing.

Brasthesis Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an amputation above the elbow, at the shoulder, or between the shoulder blades.

Brasthesis Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during 4-week time period
This trial's timeline: 3 weeks for screening, Varies for treatment, and during 4-week time period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Comfort measures with the Socket Comfort Score
Change in Prosthetic Function and Satisfaction using the Orthotic and Prosthetic Users Survey (OPUS)
Secondary outcome measures
Change in Pressure using the Tekscan F-Socket Pressure Mapping System
Change in Range of Motion
Other outcome measures
Jawbone UP24 activity tracker

Brasthesis Trial Design

1Treatment groups
Experimental Treatment
Group I: BrasthesisExperimental Treatment1 Intervention
All five participants will wear Brasthesis for 4-weeks

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,682 Total Patients Enrolled
Jeffrey T Heckman, DOPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL
1 Previous Clinical Trials
20 Total Patients Enrolled
Sandra L. Winkler, PhD MA BSPrincipal InvestigatorJames A. Haley Veterans' Hospital, Tampa, FL

Media Library

Brasthesis (Prosthetic Harness) Clinical Trial Eligibility Overview. Trial Name: NCT05179395 — N/A
Arm Amputation Research Study Groups: Brasthesis
Arm Amputation Clinical Trial 2023: Brasthesis Highlights & Side Effects. Trial Name: NCT05179395 — N/A
Brasthesis (Prosthetic Harness) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05179395 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are registered for this research trial?

"Affirmative, the information on clinicaltrials.gov shows that enrollment is currently open for this trial which was initially posted on July 18th 2022 and revised lastly on July 26th 2022. Only 5 participants are needed across 1 site."

Answered by AI

Are there any openings in the current trial for prospective participants?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical trial is currently underway; it was first uploaded on July 18th 2022 and underwent its last update seven days later. Five participants need to be admitted at a single site."

Answered by AI
~2 spots leftby Mar 2025