[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613399":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":49,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":44,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":44,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":102,"whyStopped":44,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13,14],"Device: Fillauer Slope Adaptive Foot","Device: Fillauer Motion Foot SLX",{"label":16,"type":10,"description":17,"interventionNames":18},"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.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Fillauer Slope Adaptive Foot","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.",[9,16],[26],"SAF",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Fillauer Motion Foot SLX","The SLX is an articulated, hydraulic ankle that provides passive ankle motion through damped plantarflexion and dorsiflexion to facilitate slope accommodation.",[9,16],[32],"SLX",[34,38],{"name":35,"affiliation":36,"role":37},"Sara Koehler-McNicholas, PhD MS BS","Minneapolis VA Health Care System, Minneapolis, MN","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":37},"Mary E Matsumoto, MD",[41,46],{"name":35,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","(612) 467-4017",null,"sara.koehler@va.gov",{"name":39,"role":42,"phone":47,"phoneExt":44,"email":48},"(612) 725-2000","mary.matsumoto@va.gov",[50],{"facility":36,"status":44,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Minneapolis","Minnesota","55417-2309","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-93.26384,44.97997,{"lat":60,"lon":59},[63,65,69,70],{"name":35,"role":42,"phone":64,"phoneExt":44,"email":45},"612-467-4017",{"name":66,"role":42,"phone":67,"phoneExt":44,"email":68},"Alexandria Lloyd, MS","(612) 467-4705","alexandria.lloyd@va.gov",{"name":39,"role":37,"phone":44,"phoneExt":44,"email":44},{"name":35,"role":37,"phone":44,"phoneExt":44,"email":44},{"type":72,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[74],{"name":75,"class":76},"University of Washington","OTHER","100613399","influence-of-a-slope-adaptive-foot-on-participation-of-veterans-with-lower-limb-amputations-100613399",false,"NCT07266077","Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations","Inclusion Criteria:\n\n* US military Veterans willing to travel to the Minneapolis VA Health Care System\n* Unilateral, below-knee amputation\n* Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)\n* Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)\n* Well-fitting and well-aligned prosthesis\n* Uses a prescribed energy storage and return foot (ESAR)\n* Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment)\n* Access to computer, tablet, or smartphone and internet for video conferencing and REDCap data collection\n\nExclusion Criteria:\n\n* Residual-limb skin problems\n* Not a regular prosthesis user\n* Mass over 125 kg (275 lbs)\n* Residual limb too long to accommodate the study feet (104 mm of build height)\n* Has used a hydraulic foot previously as part of clinical care or a research study\n* Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and\u002For instrumental activities of daily living\n* Baseline PROMIS-APSRA or PROMIS-SSRA scores at the maximum levels (no room for improvement on primary outcomes)","ALL","18 Years","89 Years",{"count":87,"type":88},30,"ESTIMATED","INTERVENTIONAL",[91],"NA","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.",[94],"Amputation",[96,94,97,98,99,100,101],"Artificial Limbs","Leg Prosthesis","Ankle","Community Participation","Social Participation","Falls","NOT_YET_RECRUITING","2026-05-21",{"date":105,"type":106},"2026-05-26","ACTUAL",{"date":108,"type":88},"2026-07-01",{"date":110,"type":88},"2029-08-01",{"name":5,"class":6},1]