Prosthetic Socket Fit Testing System

ConditionAmputation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Prosthetic socket fit testing system

    Device

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Individuals with transfemoral amputationOther 1 intervention

Trial outcomes

Primary outcomes

1

Repeatability

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

Time frame
1 week

Secondary outcomes

1

Practice effects

Assess how many trials are required for steady state performing the prosthetic socket fit test in terms of movement time and accuracy.

Time frame
Day 1
2

Known groups validity

Assess difference in measurement time and accuracy between loose and tight prosthetic socket fit

Time frame
Day 1
3

Convergent validity

Assess correlation between movement time and accuracy with socket comfort score for difference between tight and loose fitting prosthetic sockets.

Time frame
Day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: