Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations

NCT05179395 | Completed Results FDA Device

• 2 other identifiers: A3851-PI21RX003851-01A1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Upper Limb Amputation

Keywords

amputation; artificial limb

Outcome Measures

Primary Outcomes (3)

• 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.

  Pre and post 4-week harness wearing time

• 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.

  Pre and post 4-week harness wearing time

• 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.

  At post 4 week harness wearing time

Secondary Outcomes (2)

• Change in Range of Motion

  Pre and post 4-week harness wearing time

• Change in Pressure Using the Tekscan F-Socket Pressure Mapping System

  Pre and post 4-week harness wearing time

Other Outcomes (1)

• Activity Tracker

  4 week time frame from baseline to follow up

Study Arms (1)

Brasthesis

EXPERIMENTAL

All five participants will wear Brasthesis for 4-weeks

Device: Brasthesis

Interventions

Brasthesis DEVICE

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

Brasthesis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Intervention includes wearing a sport bra. If a male with an upper limb amputation were to want to be fitted with a sports bra, he could be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Results Point of Contact

• Title: Dr. Jeffrey Heckman
• Organization: James A Haley Veterans' Hospital and Clinics

jeffrey.t.heckman@va.gov

813.972.2000

Study Officials

• Jeffrey T Heckman, DO

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: July 18, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)