Socket Fit Testing System for above-the-knee prosthesis users
Official title: Evaluation of a Prototype Socket Fit Testing System to Assess Coupling of the Prosthetic Socket in Individuals With Lower Limb Amputation
Run by University of Washington · NCT07491614 · Data updated 2026-11-12
A non-invasive device attached to a prosthetic socket is tested to see if it helps measure and improve socket fit for people with above-the-knee amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Status | Recruiting |
| Started | October 12, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07491614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with unilateral transfemoral amputation, at least 12 months post-amputation, who wear a prosthesis at least four hours daily and can ambulate short distances.
✕Probably not a fit
Individuals unable to participate safely due to balance, hip movement limitations, or other exclusion criteria may not benefit from the device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study tests a non-invasive prototype that attaches to the end of a prosthetic socket and uses two air cylinders, sensors, and a screen to map socket movement. Participants perform leg movements against resistance while the system records movement duration and accuracy to see how well the socket and residual limb work together. The goal is to determine feasibility and validity of the device as a quantitative socket-fit assessment beyond patient feedback. The study protocol includes standardized hip movements scaled to each participant to ensure consistent difficulty across individuals. Primary outcomes focus on the system’s performance and how well it correlates with functional socket fit.
Why it matters
Potential benefit: If successful, the device could provide an objective, non-invasive way to assess and optimize socket fit for prosthesis users.
How similar studies have gone: The approach builds on prior efforts to quantify socket fit with non-invasive measurements, with this study aimed at feasibility and validity in a pilot setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * be between 18 and 70 years old * have a unilateral transfemoral amputation * be at least 12 months post-amputation * have a residual limb that is free of open wounds or infections * wear a prosthesis for a minimum of four hours per day * be able to ambulate short distances with a prosthesis * be able to stand on the intact leg for brief periods * be able to hold onto parallel bars with the arms for balance * have pain-free range of motion at the hip on the amputated side * have no back problems that make standing or hip movement difficult * have corrected vision that is sufficient to see the cursors on the screen * be able to follow simple instructions in English Exclusion Criteria: * residual limb issues (e.g. sensitive or frail skin) that may be made worse by testing * a prosthetic socket that cannot be disconnected from the distal prosthetic components * unable to read and speak English
Where it's running
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University of Washington
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Stefania Fatone, PhD, BPO(Hons) — University of Washington
- Study coordinator: Stefania Fatone, PhD, BPO(Hons)
- Email: sfaton@uw.edu
- Phone: 206-685-7918
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.