Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- PROMIS Ability to Participate in Social Roles and Activities (APSRA)
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Fillauer Slope Adaptive Foot (Device)
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.
Intervention: Fillauer Motion Foot SLX (Device)
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.
Intervention: Fillauer Motion Foot SLX (Device)
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.
Intervention: Fillauer Slope Adaptive Foot (Device)
Outcomes
Primary Outcomes
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
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.
PROMIS Satisfaction with Social Roles and Activities (SSRA)
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
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.
Secondary Outcomes
- 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)