Brasthesis Prosthetic Harness for Arm Amputation

(Brasthesis Trial)

Overseen By Nicole Cadorette

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Open wounds, Body-powered prosthetic, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new product called Brasthesis, designed for women veterans who have lost an arm. Brasthesis combines the straps of a prosthetic harness with a sturdy sports bra, enhancing comfort and customization. The goal is to improve the fit and contact of prosthetic arms, making them easier to use. Women who have had an upper arm amputation and currently use or have used a myoelectric or cosmetic prosthetic may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions tailored for women veterans.

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 prior data suggests that this prosthetic harness is safe for women Veterans with arm amputation?

Research does not provide specific safety data for the Brasthesis Prosthetic Harness. The trial's "Not Applicable" status suggests that this new product is being tested mainly for ease and comfort, rather than safety issues. Available information reports no negative effects. This aligns with the design of Brasthesis, a supportive sports bra with adjustable straps for comfort and a personalized fit.

The product is easy to wear and can be adjusted to fit each person. It is not an internal medical device, which typically means fewer safety concerns. The main goal is to assess its effectiveness and fit.

Prospective trial participants should note that while there is no hard safety data yet, the design emphasizes ease and comfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Brasthesis prosthetic harness is unique because it offers a new way to stabilize and support prosthetic arms for people with arm amputations. Unlike traditional harnesses that can be bulky and uncomfortable, the Brasthesis is designed to be more lightweight and ergonomic, potentially improving comfort and usability for wearers. Researchers are excited about Brasthesis because it may enhance the user's range of motion and provide a more natural feel, allowing for improved functionality in daily activities. This innovation could lead to better adoption and satisfaction among prosthetic users compared to current options.

What evidence suggests that the Brasthesis prosthetic harness is effective for arm amputation?

Research shows that Brasthesis aims to improve comfort and functionality for women who have lost an upper limb. A good prosthetic harness should secure the prosthetic, allow easy movement, and be comfortable. Studies have found that comfort and fit greatly influence user satisfaction and prosthetic use. Brasthesis combines the harness with a sports bra, potentially making prosthetic use more comfortable and convenient for daily activities. Early results suggest that a custom fit might enhance the connection between the prosthetic's sensor and the limb, improving performance and user satisfaction. ^{1 6 7 8 9}

Who Is on the Research Team?

Jeffrey T Heckman, DO

Principal Investigator

James A. Haley Veterans' Hospital, Tampa, FL

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Brasthesis

Trial Overview 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.

How Is the Trial Designed?

Group I: Brasthesis Experimental Treatment 1 Intervention

All five participants will wear Brasthesis for 4-weeks

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-6-2022-65d1f

Brasthesis Prosthetic Harness for Arm Amputation 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, ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/95/NCT05179395/ICF_000.pdf

Brasthesis Prototype for Women Veterans with Upper Limb ... The study is about testing a potentially more comfortable prosthetic harness for women with unilateral amputations. This initial information is to give you ...

3. trialx.com trialx.com/clinical-trials/listings/254865/brasthesis-prosthetic-harness-for-women-veterans-with-upper-limb-amputations/

Brasthesis Prosthetic Harness for Women Veterans With ... At the time of Brasthesis fitting, baseline will be collected, demographic and clinical data and satisfaction, function, and comfort outcomes measures.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/95/NCT05179395/SAP_002.pdf

Brasthesis™ Prototype for Women Veterans with Upper Limb ... An effective harness must help hold the prosthetic socket securely on the limb, facilitate a functional range of motion, and remain comfortable when worn [26].

5. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2020.1866684

Current rates of prosthetic usage in upper-limb amputees Depending on the level of amputation, prosthetic usage rates in upper extremity amputees ranging from 9 to 81% can be found in literature [ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27281955/

Overview: Mechanism and Control of a Prosthetic Arm Continuous growth in industrialization and lack of awareness in safety parameters the cases of amputations are growing. The search of safer, simpler and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/den120016.pdf

DEKA ARM SYSTEM FDA identifies this generic type of device ... The safety and effectiveness of the DEKA Arm System has not been established for bilateral amputees that include a unilateral or bilateral transhumeral or.

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05179395?keyword=%22Upper%20Limb%22

Brasthesis Prosthetic Harness for Women Veterans With ... The exclusion criteria are: (1) open wounds in the upper torso or extremities and (2) body-powered prosthetic users due to the dynamic requirements of the ...

9. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/index/oxford/upper-extremity-prosthetic-devices-ohp-04012025.pdf

Upper Extremity Prosthetic Devices – Oxford Clinical Policy An upper extremity prosthetic for amputations is proven and medically necessary when all of the following criteria are met:.