Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
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About
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.
Full 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 hydraulic feet have reduced energy storage and return compared to ESAR feet.
To combine the benefits of ESAR and typical hydraulic feet, the Minneapolis VA, in collaboration with Fillauer Motion Control, Inc., has developed a novel hydraulic Slope Adaptive Foot (SAF). During pilot testing, most Veterans preferred the SAF over their prescribed ESAR foot and reported improvements in participation. Further research is needed to evaluate the impact of different prosthetic feet on participation and fall-related health in order to identify which patients are best suited for an ESAR foot, a typical hydraulic foot, or the SAF.
Innovation and Impact - The long-term goal of this project is to inform prescription of hydraulic feet for Veterans living with lower-limb amputation to optimize their participation in important life roles and activities. Results of this study will help to develop evidence-based provider training and patient education materials to assist with precision rehabilitation and a patient-centered care approach to prescribing hydraulic prosthetic feet.
Aim 1 - Evaluate the influence of different prosthetic foot-related factors on participation. PROMIS Ability to Participate in Social Roles and Activities (APSRA) and PROMIS Satisfaction with Social Roles and Activities (SSRA) will be administered during a cross-over randomized control trial (RCT). This aim will test the hypothesis that using the SAF will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores relative to a typical hydraulic foot and that using either hydraulic foot will be associated with greater PROMIS-APSRA and/or PROMIS-SSRA scores compared to the ESAR foot.
Aim 2 - Characterize the lived experiences of Veterans using their preferred prosthetic foot to inform clinical decision making. Mixed-methods will be used to explore how participation in social roles and activities is influenced by hydraulic and ESAR feet. Gaining a deeper understanding of Veterans' experiences across a range of situations and environments will inform the development of evidence-based education materials.
Exploratory Aim - Evaluate the influence of different prosthetic foot-related factors on fall-related health outcomes. The Prosthetic Limb Users Survey of Fall-Related Health (PLUS-FRH), which includes four distinct and important domains, will be administered during a cross-over RCT. This aim will test the hypothesis that using the SAF will be associated with improved fall-related health outcomes relative to a typical hydraulic foot and that using either hydraulic foot will be associated with improved fall-related health outcomes compared to the ESAR foot.
Methodology - To address these aims, this study will 1) conduct a cross-over RCT of the SAF versus a typical hydraulic foot (Motion Foot SLX, Fillauer) among 30 Veterans with a below-knee amputation who use an ESAR foot and have no prior experience with a hydraulic foot, and 2) conduct a one-year observational study in which Veterans use their preferred prosthetic foot. Participants will complete quantitative (PROMIS-APSRA, PROMIS-SSRA, PLUS-FRH) and qualitative (semi-structured interviews) assessments at baseline and after each period of the cross-over RCT and quarterly during the one-year observational study. A participatory method will be used in which Veterans will be asked to share photos with a short narrative to portray their experiences with their preferred prosthetic foot to prompt discussion during the quarterly interviews of the one-year observational study.
Participating Sites - Minneapolis VA Health Care System (data collection site) and the University of Washington.
Duration of Participant Intake (Study Duration) - This project is projected to occur over four years. The project will begin with a 3-month start-up period and recruitment will continue for 18 months following start-up. Data collection will conclude with 9 months remaining in the study timeline, which will be used for data analysis, dissemination, development of implementation materials, and study closure.
Path to Implementation - Data gathered from this study will be used to draft evidence-based education materials for providers and Veterans. These materials, which will provide pertinent and useful information about foot options (ESAR, SLX, SAF) for prosthetic prescription, will be used in a future implementation study.
Enrollment
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Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
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Central trial contact
Sara Koehler-McNicholas, PhD MS BS; Mary E Matsumoto, MD
Data sourced from clinicaltrials.gov
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