Actively Recruiting
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
Eligibility Criteria
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)
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
Trial Site Locations
Total: 1 location
1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Actively Recruiting
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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