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
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
Treatments tested in this trial
- Prosthetic socket fit testing system
Treatment groups
Locations
Sponsors and collaborators
University of Washington
Lead sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator