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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Prosthetic socket fit testing system
DeviceProsthetic socket fit testing system to assess socket-limb coupling using movement error and duration.
Treatment groups
Trial outcomes
Primary outcomes
Repeatability
Assess repeatability of performing the prosthetic socket fit test in terms of movement time and accuracy.
Secondary outcomes
Practice effects
Assess how many trials are required for steady state performing the prosthetic socket fit test in terms of movement time and accuracy.
Known groups validity
Assess difference in measurement time and accuracy between loose and tight prosthetic socket fit
Convergent validity
Assess correlation between movement time and accuracy with socket comfort score for difference between tight and loose fitting prosthetic sockets.
Locations
Sponsors and contacts
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University of Washington
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
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