Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
VA Office of Research and Development
Summary
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.
Description
Background and Relevance to VA - Over 90% of Veterans who use a below-knee prosthesis in the community are prescribed an energy storage and return (ESAR) foot. ESAR feet are designed to assist with forward propulsion during walking, which many users find helpful for certain activities. However, ESAR feet lack ankle articulation, making it difficult to walk on non-level surfaces. To overcome this limitation, typical hydraulic feet incorporate damped ankle motion to accommodate walking on uneven terrain. While potentially improving aspects of participation and fall-related health, typical hydrau…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) * Well-fitting and well-aligned prosthesis * Uses a prescribed energy storage and return foot (ESAR) * Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment) * Access to computer, ta…
Interventions
- DeviceFillauer Slope Adaptive Foot
The SAF uses an articulated ankle and damped plantarflexion to accommodate slopes and uneven terrain. It locks when the forefoot reaches the ground at the beginning of stance phase, which allows the SAF to re-align, or adapt, to the walking surface. After the SAF locks, the laminated foot plate can deflect and store energy as dorsiflexion occurs, returning that energy to the user in late stance for forward propulsion. Finally, at the end of stance phase, when the toe leaves the ground, the SAF unlocks and actively dorsiflexes the ankle to increase toe clearance during swing.
- DeviceFillauer Motion Foot SLX
The SLX is an articulated, hydraulic ankle that provides passive ankle motion through damped plantarflexion and dorsiflexion to facilitate slope accommodation.
Location
- Minneapolis VA Health Care System, Minneapolis, MNMinneapolis, Minnesota