Actively Recruiting

Phase Not Applicable
All Genders
Healthy Volunteers
NCT05990062

Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality

Led by VA Office of Research and Development · Updated on 2025-06-26

25

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

S

Stumpworx LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research and development will improve upon and investigate the potential validity of an innovative new transradial socket and harness design (the KSH system) that offers an alternative to standard hard sockets and rubber liners with a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The project consists of designing, custom fitting and evaluating the function and comfort of the this new novel system. The study will take place in 3 phases; Phase 1, five experienced Veterans with transradial arm amputations will be recruited to provide guidance and to assist with the design and development. Experienced end-user Veterans and Clinical staff will work together to assist with design, develop the fitting process and working with engineers on the design of a completely digital fitting device for measuring the residual limb and locating bony prominences of the limb to inform the socket design. Phase 2, testing and assessment, the design and process validation will take place with the five Veteran upper transradial arm amputees Phase 3, an additional 20 Veterans with transradial arm amputations will be recruited and fit with the KSH system and undergo a series of evaluative tests. Veterans will perform a series of static and dynamic tasks to evaluate function, comfort and load bearing failure. The primary goal of this study is to improve upon the current preliminary prototype and to test it with a broader population of potential users to help advance the engineering and design, and to learn the potential to fit a range of Veterans with transradial amputations.

CONDITIONS

Official Title

Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral transradial arm amputation
  • Possession of a functioning and wearable previously fit prosthetic arm of any type
  • Residual limb length of at least 4 inches from the lateral epicondyle to the distal tip
  • Residual limb length allowing clearance of 1.5 inches or less from a fitted wrist
  • At least 5 years of prosthetic use experience (for Phase 1 and 2 participants)
  • At least 1 year of prosthetic use experience (for Phase 3 participants)
Not Eligible

You will not qualify if you...

  • Current open sores, incisions, heterotopic ossification, traumatic neuromas, or any other condition preventing wearing a prosthetic socket
  • Residual limb length less than 4 inches
  • Residual limb length greater than allowing 1.5 inches clearance from a fitted wrist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States, 15240

Actively Recruiting

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Research Team

E

Elizabeth B Toth, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Improving Prosthetic Arms for Amputee: A Better Fit and More Functionality | DecenTrialz