RecruitingNot ApplicableNCT07266077

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

Sponsor

VA Office of Research and Development

Enrollment

30 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Amputation

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.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria8

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, tablet, or smartphone and internet for video conferencing and REDCap data collection

Exclusion Criteria7

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)
Has used a hydraulic foot previously as part of clinical care or a research study
Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
Baseline PROMIS-APSRA or PROMIS-SSRA scores at the maximum levels (no room for improvement on primary outcomes)

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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.