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Upper Limb AmputationBrasthesisNCT05179395

Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations

A study testing Brasthesis in people with Upper Limb Amputation, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Upper Limb Amputation
What is being tested?
Brasthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
18 Jul 2022to 14 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • mid to short transhumeral, shoulder, or interscapulothoracic unilateral amputation,
  • 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.

Who cannot join

  • open wounds in the upper torso or extremities,
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James A. Haley Veterans' Hospital, Tampa, FL

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Brasthesis Prototype for Women Veterans With Upper Limb Amputations

This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra. The position of the harnessing straps are individualized for each woman so that the prosthesis can be positioned for optimal contact between the prosthetic sensor and the residual limb. The investigators foresee Brasthesis being available as an adaptable sports bra that comes with a goodie bag of spare parts that can be used to customize Brasthesis. The investigators plan to develop Brasthesis to be machine washable and relatively inexpensive so that Veterans can have more than one in a variety of colors.

Read the detailed description

Current traditional prosthetic chest harnessing worn by women Veterans with limb loss) is less than optimal due to female anatomy. The investigators know from the sports and seat belt/airbag literature that breast tissue injuries can disrupt the blood flow to the breast resulting in swelling, significant blood loss, hematoma, fat necrosis, and oil cyst hematoma. Injury to the mammary ducts can affect the future or current flow of breast milk. More commonly, smaller superficial arteries along with veins become injured, leading to more localized injury and less serious bleeding and bruising. While there is no known research on whether a prosthetic harness can cause injury to breast tissue, the investigators know that frequent wearing of tight clothing can cause bruising, swelling, and thrombophlebitis. The investigators have designed a bra with incorporated prosthetic harness prototype for women Veterans with mid to short transhumeral, shoulder, or interscapulothoracic amputation(s) that the investigators have named Brasthesis (patent pending). The purpose of the proposed project is to use a case series design to prove the concept of Brasthesis prototype. The specific aims of this project are to: (1) Compare the satisfaction and function with and comfort of Brasthesis with the traditional harness and (2) Use pressure mapping to compare the interface pressure of Brasthesis with the traditional prosthesis. Five women with proximal upper limb loss will be fit with Brasthesis using a procedure similar to the one the investigators used for constructing the prototype. The inclusion criteria are: (1) unilateral mid to short trans-humeral, shoulder, or interscapular-thoracic unilateral amputation and (2) have an existing myoelectric or hybrid prosthetic limb that they used or rejected/abandoned. The additional resources required to train a participant with no prosthetic experience is judged beyond SPIRE resources/scope of this study. 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 harness. The investigators will pursue Using Brasthesis with body powered prosthetics in a subsequent study. Once the patient has provided written informed consent, two bras will be ordered. One bra the patient will wear. The second bra will be deconstructed and reconstructed for individualized suspensory harness strapping. At the time of Brasthesis fitting, baseline will be collected, demographic and clinical data and satisfaction, function, and comfort outcomes measures. After fitting, the participant will wear Brasthesis for four weeks. Participants will be contacted weekly to track wearing time in days per week and hours per day (Aim 1). The investigators will also employ a Jawbone Up 24 activity tracker as a quantitative proxy of prosthesis wear time. Pre to post ordinal change in wearing time, satisfaction, function, and comfort outcomes will be analyzed using quantitative descriptive analyses. At the end of the wearing period, PI Winkler will conduct semi-structured phone interviews with participants and the prosthetist. Interviews will be transcribed and analyzed using thematic analysis guided by descriptive phenomenology theory. The semi-structured interview will have three overall discussion points: (1) Describe the barriers encountered while fitting Brasthesis , (2) How did you manage strap placement based on the presence and length of the residual limb and the available skin surface area available for contact with the prosthetic sensor, and (3) How does Brasthesis compare with traditional prosthesis? Aim 2 will use pressure mapping technology to compare the residual limb and intact limb under arm pressure distribution data for Brasthesis and participants' traditional prostheses. The investigators will create color-coded 'heat maps' that directly link pressure values to the three-dimensional anatomy of each participant.

Being tested
Brasthesis
Keywords
amputation, artificial limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrasthesisDevice

    Brasthesis is a harness that is integrated with an off the shelf sports bra

Study groups in NCT05179395
Study groupRoleWhat they receive
BrasthesisExperimentalAll five participants will wear Brasthesis for 4-weeks
Receives: Device: Brasthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS)

    One of the OPUS self-report survey modules is the Upper Extremity Functional Status Survey which will be used to measure change:

    The Upper Extremity Functional Status Survey- when wearing a traditional and Brasthesis harness.

    1. The Upper Extremity Functional Status Survey has 28 items that are rated on a 5-point Likert type scale with a a possible range from 0 to 112 with a higher score representing a higher level of independent function.

    Measured: Pre and post 4-week harness wearing time

  2. Change in Comfort Measures With the Socket Comfort Score

    The change in comfort will be measured between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post).

    The Socket Comfort Score is a 1-item measure that rates comfort on a 11-point Likert-type scale with a range of 0-10. A higher score indicates more comfort.

    Measured: Pre and post 4-week harness wearing time

  3. Satisfaction With Devices

    The Satisfaction with Device Survey has 11 items that are rated on a 5-point Likert type scale with a a possible range from 11 to 55 with a higher score representing a better outcome, e.g., more satisfaction.

    Measured: At post 4 week harness wearing time

Secondary outcomes (2)
  1. Change in Range of Motion

    Change in range of motion of the residual limb will be measured using a goniometer.

    Normal values for shoulder flexion range from 0-180 Normal values for shoulder extension range from 0-60 Normal values for shoulder adduction range from 0-50 Normal values for shoulder abduction range from 0-180

    Measured: Pre and post 4-week harness wearing time

  2. Change in Pressure Using the Tekscan F-Socket Pressure Mapping System

    The change in pressure between the residual limb and socket and axilla of intact arm will be measured with the traditional harness (pre) ad Brasthesis (post). Data reported as mean max pressure mmHg

    Normal range of pressure readings are 0-250 mmHg

    Measured: Pre and post 4-week harness wearing time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start18 Jul 2022
  3. Primary completion14 Mar 2024
  4. Study completion14 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
All Participants unilateral upper limb amputation participants will wear the Brasthesis harness with their prosthetic arm for 4 weeks. Each subject served as their own control with baseline data collected at visit 1 and interventional data collected after 4 weeks.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179395
Sponsor's protocol ID
A3851-P
Other IDs
I21RX003851-01A1
Acronym
Brasthesis
Status last verified
May 2025
First submitted
16 Dec 2021
Last updated
23 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brasthesis in people with Upper Limb Amputation, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Prosthetic Function and Satisfaction Using the Orthotic and Prosthetic Users Survey (OPUS) (time frame: Pre and post 4-week harness wearing time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

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