What side effects are associated with this type of intervention?

Common treatments for arm amputation include the use of prosthetic devices, which can sometimes cause skin irritation, pressure sores, and discomfort due to improper fit or alignment. The Brasthesis trial, which integrates harnessing straps into a sports bra, aims to improve comfort and positioning. Potential side effects of such integrated systems may include localized skin irritation or discomfort from the straps, but these are generally minimized with proper fitting and adjustment.

What prior FDA approvals exist?

The FDA has approved various prosthetic devices and technologies for the treatment of arm amputation. These include myoelectric prostheses, which use electrical signals from the residual limb muscles to control the prosthetic hand, and body-powered prostheses, which use cables and harnesses to operate the device. While specific FDA approvals for integrated harnessing straps in a sports bra, like the Brasthesis, are not detailed, the concept aligns with the broader trend of developing more comfortable and functional prosthetic solutions. Innovations in prosthetic design continue to focus on improving the fit, comfort, and usability for amputees.

What other types of research exist?

Promising alternatives to Brasthesis for arm amputation patients include: 1) Myoelectric prostheses with advanced sensor technology for improved control and natural movement. 2) Osseointegration, which involves directly anchoring the prosthesis to the bone, eliminating the need for traditional harnesses. 3) Modular prosthetic systems that allow for easy customization and interchangeability of components to suit individual needs. 4) Soft robotic prostheses that offer enhanced dexterity and adaptability through flexible, lightweight materials.

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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

Must not have

open wounds in the upper torso or extremities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during 4-week time period

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during 4-week time period

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Comfort measures with the Socket Comfort Score

Change in Prosthetic Function and Satisfaction using the Orthotic and Prosthetic Users Survey (OPUS)

Secondary study objectives

Change in Pressure using the Tekscan F-Socket Pressure Mapping System

Change in Range of Motion

Other study objectives

activity tracker

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BrasthesisExperimental Treatment1 Intervention

All five participants will wear Brasthesis for 4-weeks

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for arm amputation involve the use of prosthetic devices, which can be either body-powered or myoelectric. Body-powered prostheses use a harness and cable system to control the prosthetic limb through movements of the residual limb and shoulder. Myoelectric prostheses, on the other hand, use electrical signals from the muscles in the residual limb to control the prosthetic hand and arm. The Brasthesis trial introduces an innovative approach by integrating harnessing straps into a sports bra, allowing for optimal positioning and comfort. This matters for arm amputation patients as it enhances the fit and functionality of the prosthesis, improves comfort, and allows for better control and ease of use, ultimately leading to improved quality of life and greater independence.

Prosthetic rehabilitation for older dysvascular people following a unilateral transfemoral amputation.