[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613235":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":29,"centralContacts":38,"locations":48,"responsibleParty":71,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":29,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":98,"overallStatus":51,"whyStopped":29,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Two prosthetic foot stiffness categories stiffer than the as-prescribed prosthetic foot stiffness","ACTIVE_COMPARATOR","A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal (as-currently prescribed) foot.",[13],"Device: A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot",{"label":15,"type":10,"description":16,"interventionNames":17},"Two prosthetic foot stiffness categories softer than the as-prescribed prosthetic foot stiffness","A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot. The prosthetic foot type, including the manufacturer and length, will remain the same as the nominal foot.",[18],"Device: A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot",{"label":20,"type":10,"description":21,"interventionNames":22},"As-prescribed prosthetic foot stiffness","The prosthetic foot that is currently prescribed and used by each participant daily.",[23],"Device: As-prescribed prosthetic foot stiffness",[25,30,34],{"type":26,"name":20,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Each participant will complete a motion capture collection, tests of physical function, and sensory tests in their currently prescribed prosthetic foot.",[20],null,{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"A prosthetic foot that is two prosthetic foot stiffness categories stiffer than the stiffness of the as-prescribed prosthetic foot","Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories stiffer than their currently prescribed prosthetic foot.",[15],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"A prosthetic foot that is two prosthetic foot stiffness categories softer than the stiffness of the as-prescribed prosthetic foot","Each participant will complete a motion capture collection, tests of physical function, and sensory tests in a prosthetic foot that is two categories softer than their currently prescribed prosthetic foot.",[9],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Brecca Gaffney, PhD","CONTACT","303-315-7559","BRECCA.GAFFNEY@UCDENVER.EDU",{"name":45,"role":41,"phone":46,"phoneExt":29,"email":47},"Natalie Harpenau, MS","‪(720) 772-6887","NATALIE.HARPENAU@CUANSCHUTZ.EDU",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of Colorado, Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045-2559","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-104.83192,39.72943,{"lat":61,"lon":60},[64,66,67,69],{"name":65,"role":41,"phone":46,"phoneExt":29,"email":47},"Natalie Harpenau, M.S",{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},{"name":40,"role":68,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":70,"role":68,"phone":29,"phoneExt":29,"email":29},"Jason Stoneback, MD",{"type":72,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[74],{"name":75,"class":76},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100613235","phase-1-influence-of-prosthetic-foot-stiffness-on-transtibial-osseointegrated-bone-anchored-limb-outcomes-100613235",false,"NCT07263945","Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes","TBAL","Inclusion Criteria:\n\n* Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes\n* \\> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group)\n* \\> 12-months limb amputation (Socket Control group)\n* Non-vascular amputation etiology\n* Low profile prosthetic foot (nominal)\n* Can walk unassisted for 5-minutes\n* \\> 18 years old\n\nExclusion Criteria:\n\n* Major amputation on contralateral limb\n* Vascular amputation etiology\n* Neurologic pathology that impairs coordination\u002Fbalance\n* Regular assistive device use required for community ambulation\n* Inflammatory diseases or diabetes\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.",[94,95,96,97],"Amputation","Transtibial Amputation - Unilateral","Bone Anchored Devices","Osseointegration",[99,100,101,102,103,104],"amputation","bone anchored limb","osseointegration","transtibial amputation","below knee amputation","prosthetics","2026-04-20",{"date":107,"type":108},"2026-04-21","ACTUAL",{"date":110,"type":108},"2025-11-25",{"date":112,"type":88},"2030-05-31",{"name":5,"class":6},1]