Recruiting

Socket Fit Testing

Sponsor:

University of Washington

Code:

NCT07491614

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Prosthetic socket fit testing system

Study Details

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

Study ID

NCT07491614

Start date

Oct 12, 2026

Status verified date

Oct, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Individuals with transfemoral amputation

Prosthetic socket fit testing system

Interventions

Prosthetic socket fit testing system

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

Primary outcome measure

  • Repeatability [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Stefania Fatone, PhD, BPO(Hons)

206-685-7918sfaton@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Stefania Fatone, PhD

206-685-7918sfaton@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • prosthesis
  • assessment
  • socket fit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Washington on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.