About this trial
Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.
Eligibility criteria
Qualifiers
US military Veterans willing to travel to the Minneapolis VA Health Care System
Unilateral, below-knee amputation
Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)
Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)
Disqualifiers
Residual-limb skin problems
Not a regular prosthesis user
Mass over 125 kg (275 lbs)
Residual limb too long to accommodate the study feet (104 mm of build height)
Trial design
Treatments tested in this trial
- Fillauer Slope Adaptive Foot
- Fillauer Motion Foot SLX
Treatment groups
Sponsors and collaborators
VA Office of Research and Development
Lead sponsor
University of Washington
Collaborator