Prosthetic Socket Fit Testing System

NCT07491614 | Not Yet Recruiting

• 2 other identifiers: STUDY00023726UL1TR002319
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Amputation

Keywords

prosthesis; assessment; socket fit

Outcome Measures

Primary Outcomes (1)

• Repeatability

  Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy.

  1 week

Secondary Outcomes (3)

• Practice effects

  Day 1

• Known groups validity

  Day 1

• Convergent validity

  Day 1

Study Arms (1)

Individuals with transfemoral amputation

OTHER

Prosthetic socket fit testing system

Device: Prosthetic socket fit testing system

Interventions

Prosthetic socket fit testing system DEVICE

Prosthetic socket fit testing system to assess socket-limb coupling using movement error and duration.

Individuals with transfemoral amputation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Officials

• Stefania Fatone, PhD, BPO(Hons)

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Fatone, PhD, BPO(Hons)

CONTACT

206-685-7918; sfaton@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share