A more comfortable, breathable transradial socket and harness for arm prostheses
The Advancement of a New Variable-Compliance Socket and Frame System for Transradial Amputees to Optimize Socket Fit and Upper Limb Function
This project will test a new hybrid polymer-and-textile transradial socket and harness to see if it improves comfort, breathability, and function for people with a unilateral transradial amputation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05990062 on ClinicalTrials.gov |
What this trial studies
The project will design, custom-fit, and test a novel K-Socket-Harness (KSH) that uses hybrid polymer and textile materials inspired by advanced athletic shoe technology. Phase 1 will recruit five experienced Veteran end users to co-design the device and help develop a digital fitting system that maps residual limb shape and bony prominences. Phase 2 will involve iterative testing of fit, comfort, breathability, and functional use with refinements based on user and clinical feedback. A later phase will expand testing to compare user wear time and task performance against participants' existing prostheses.
Who should consider this trial
Good fit: Adults with a unilateral transradial amputation who currently wear a functioning prosthetic, have a residual limb of at least 4 inches and within the study's wrist-clearance limits, and meet the prosthetic-use experience requirement (≥5 years for Phases 1–2, ≥1 year for Phase 3) are ideal candidates.
Not a fit: Patients with open sores, heterotopic ossification, traumatic neuromas, or residual limb lengths outside the specified range are unlikely to be eligible or to benefit from this device.
Why it matters
Potential benefit: If successful, the KSH system could make prosthetic arms more comfortable and breathable, increasing wear time and functional use in daily activities.
How similar studies have performed: Previous attempts at breathable or porous liner technologies have had mixed results and this specific hybrid polymer-textile approach is relatively novel and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Rory A Cooper, PhD — VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Study coordinator: Elizabeth B Toth, BA
- Email: elizabeth.toth2@va.gov
- Phone: (412) 954-5382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.