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Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

5 Participants Needed

Brasthesis Prosthetic Harness for Arm Amputation
(Brasthesis Trial)

Overseen ByNicole Cadorette

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Open wounds, Body-powered prosthetic, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Brasthesis Prosthetic Harness for Arm Amputation?

The research shows that adaptations to prosthetic harnesses can help patients with limited shoulder and trunk mobility use their prostheses more effectively, and early fitting of prostheses can lead to quick recovery and return to daily activities. Additionally, most patients with below-elbow amputations benefit from using prostheses, suggesting that similar harness adaptations like Brasthesis could be effective.¹ ² ³ ⁴ ⁵

Is the Brasthesis Prosthetic Harness safe for human use?

The available research does not provide specific safety data for the Brasthesis Prosthetic Harness, but it does mention adaptations for prosthetic harnesses that help patients with limited mobility, suggesting some level of safety and usability in humans.¹ ³ ⁶ ⁷ ⁸

How does the Brasthesis Prosthetic Harness differ from other treatments for arm amputation?

The Brasthesis Prosthetic Harness is unique because it adapts to allow easier donning and doffing (putting on and taking off) for patients with limited shoulder and trunk mobility, unlike traditional harnesses that can be difficult to manage. This makes it more accessible and comfortable for users who struggle with conventional prosthetic systems.¹ ⁶ ⁹ ¹⁰ ¹¹

Research Team

Jeffrey T Heckman, DO

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

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

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.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fitting and Baseline Assessment

Participants are fitted with Brasthesis and baseline demographic and clinical data are collected

1 week

1 visit (in-person)

Treatment

Participants wear Brasthesis for four weeks, with weekly contact to track wearing time and outcomes

4 weeks

Weekly contact (virtual)

Follow-up

Participants are monitored for changes in prosthetic function, satisfaction, and comfort after the treatment period

2 weeks

1 visit (in-person)

Treatment Details

Interventions

Brasthesis

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: BrasthesisExperimental Treatment1 Intervention

All five participants will wear Brasthesis for 4-weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A systematic study involving 183 below-knee and 100 above-knee amputees found that patients can tolerate a range of alignment variations in their prostheses, with shifts of up to 148 mm and tilts of 17 degrees being acceptable.

The study highlights the significant impact of different prosthetists on alignment outcomes, suggesting that multiple configurations can still provide comfort and function for amputees, challenging the previous belief in a single 'optimum alignment'.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alignment of lower-limb prostheses.Zahedi, MS., Spence, WD., Solomonidis, SE., et al.[2022]

A new prosthetic device was developed for a 19-year-old patient with brachial plexus paralysis and below-elbow amputation, combining mechanical and myoelectric features to improve functionality.

This innovative device aimed to provide better results than conventional mechanical prostheses and myoelectric systems, addressing the unique needs of the patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prosthetic appliance for a patient with a brachial plexus injury and forearm amputation: a case report.Van Laere, M., Duyvejonck, R., Leus, P., et al.[2022]