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

NCT07266077 | Not Yet Recruiting

• 1 other identifier: RRD4-004-24W
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation

Keywords

Artificial Limbs; Amputation; Leg Prosthesis; Ankle; Community Participation; Social Participation; Falls

Outcome Measures

Primary Outcomes (2)

• PROMIS Ability to Participate in Social Roles and Activities (APSRA)

  This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-APSRA specifically measures the frequency with which one has trouble with completing or needs to limit participation in social roles and activities, including leisure activities and activities with friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of ability to participate.

  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

• PROMIS Satisfaction with Social Roles and Activities (SSRA)

  This Patient Reported Outcome Measurement Information System (PROMIS) short form is an 8-item self-report survey instrument, developed from PROMIS item banks, that provides T scores (mean = 50, SD = 10) based on a normative sample from a general population of healthy US adults. The PROMIS-SSRA measures the level of satisfaction with one's ability to participate in recreational activities, activities of daily living, and to meet the needs of friends and family. This PROMIS measure uses a 5-point ordinal response scale, where higher values indicate a higher degree of satisfaction with participation.

  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

Secondary Outcomes (1)

• Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH)

  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

Other Outcomes (13)

• Timed Up and Go (TUG)

  Day 1 of the RCT, after each 4-week intervention in the RCT, and at the end of the 1-year observational period of the study

• 10-meter Walk Test (10MWT)

  Day 1 of the RCT, after each 4-week intervention in the RCT, and at the end of the 1-year observational period of the study

• Modified Five-Time Sit-to-Stand (m5xSTS)

  Day 1 of the RCT, after each 4-week intervention in the RCT, and at the end of the 1-year observational period of the study

Study Arms (2)

SAF-SLX

EXPERIMENTAL

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.

Device: Fillauer Slope Adaptive Foot; Device: Fillauer Motion Foot SLX

SLX-SAF

EXPERIMENTAL

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.

Device: Fillauer Slope Adaptive Foot; Device: Fillauer Motion Foot SLX

Interventions

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.

Also known as: SLX

SAF-SLX; SLX-SAF

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.

Also known as: SAF

SAF-SLX; SLX-SAF

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: collaborator
• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Study Officials

• Sara Koehler-McNicholas, PhD MS BS

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

• Mary E Matsumoto, MD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Koehler-McNicholas, PhD MS BS

CONTACT

(612) 467-4017; sara.koehler@va.gov

Mary E Matsumoto, MD

CONTACT

(612) 725-2000; mary.matsumoto@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This study includes two distinct phases. The first is a cross-over randomized controlled trial (RCT) with a four-week take-home period to test two hydraulic foot types: the SAF and a typical hydraulic foot (Fillauer Motion Foot SLX). The second phase of this study is a one-year observational period of the Veteran's preferred foot (ESAR, SAF, or SLX).

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)