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โ† Trials
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Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations

RecruitingNAAges 18 Years - 89 YearsAllVA Office of Research and Development
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In plain words

What the trial is, and whether it could suit you

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 randomiz

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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, tablet, or smartphone and internet for video conferencing and REDCap data collection Exclusion Criteria: * 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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What it tests

  • Fillauer Slope Adaptive Foot
  • Fillauer Motion Foot SLX
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Where

1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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