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

RecruitingNAAges any - anyAllVA Office of Research and Development
NCT05990062 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 less than or equal to that allowing a clearance of 1.5 inches from a fitted wrist * Must have at least 5-years of prosthetic use experience (For Phase 1 \& 2) * Must have at least 1-year of prosthetic use experience (For Phase 3 only) Exclusion Criteria: * Current open sores or incisions, Heterotopic ossification (HO), traumatic neuromas, or any other condition preventing the wearing of a prosthetic socket * Residual limb length less than 4 inches * Residual limb length greater than that allowing 1.5 inches clearance from a fitted wrist. The investigators will make every effort to recruit Veterans. If its found that it is not possible to recruit enough Veterans, the investigators will perform a non-Veteran amendment to this protocol.
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What it tests

  • K-Socket-Harness
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Where

1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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