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

NCT05990062 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-26

No results posted yet for this study

Summary

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

  • Amputation, Surgical

Interventions

DEVICE

K-Socket-Harness

A transradial socket and harness design that offers a hybrid polymer and textile-based design derived from advanced athletic shoe technology. The KSH integrated socket, frame, and wrist, the "variable compliance prosthetic socket with breathable matrix," creates a dynamic and secure attachment with a combination of two lacing systems. The lacing systems lengthen and shorten six flexible hinges at the elbow, maintaining a secure attachment throughout the range of motion and accounting for volume changes in the soft tissue of the elbow that would otherwise restrict range of motion or cause the socket to separate from the residual limb.

Sponsors & Collaborators

  • Stumpworx LLC

    collaborator UNKNOWN

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Rory A Cooper, PhD · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-05-31
Completion
2028-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990062 on ClinicalTrials.gov