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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
VA Office of Research and Development
Study ID
NCT07266077
Status
Not Yet Recruiting

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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Fillauer Slope Adaptive Foot — DEVICE
    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.
  • Fillauer Motion Foot SLX — DEVICE
    The SLX is an articulated, hydraulic ankle that provides passive ankle motion through damped plantarflexion and dorsiflexion to facilitate slope accommodation.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SAF-SLX
    Participants in this arm will start the cross-over randomized controlled trial with the SAF. After a four-week take-home period with the SAF, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SLX for a four-week take-home period.
  • Experimental: SLX-SAF
    Participants in this arm will start the cross-over randomized controlled trial with the SLX. After a four-week take-home period with the SLX, participants will return to their usual prosthetic foot for a four-week washout period. They will then be fit with the SAF for a four-week take-home period.

Primary Outcome Measure

PROMIS Ability to Participate in Social Roles and Activities (APSRA) [ Time Frame: Day 1 of the RCT, after each 4-week intervention in the RCT, and 13 weeks, 26 weeks, 39 weeks, and 52 weeks into the 1-year observational period of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Sara Koehler-McNicholas, PhD MS BS
[email protected]
612-467-4017
Alexandria Lloyd, MS
[email protected]
(612) 467-4705
Mary E Matsumoto, MD (PRINCIPAL_INVESTIGATOR)
Sara Koehler-McNicholas, PhD MS BS (PRINCIPAL_INVESTIGATOR)

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By research site
Minneapolis VA Health Care System, Minneapolis, MN· Minneapolis, MN

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