Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations

ConditionAmputation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

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

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor

University of Washington

Collaborator