Prosthetic Socket Fit Testing System

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Apr 1, 2026 to Oct 12, 2026
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 15 words
    • Study description expanded, about 5 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Ensuring a well fitting prosthetic socket is a major challenge in the care of people with amputation. Poor fit causes pain, skin issues, reduced mobility, and lower satisfaction, affecting daily activity and quality of life. Current prosthetic socket fit assessment relies on prosthesis user feedback, prosthetist experience or intrusive equipment. The investigators have developed a non-invasive prototype socket fit testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.
Trial Details
NCT Number NCT07491614
Lead Sponsor University of Washington
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)
Amputation
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov