[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637147":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":53,"collaborators":55,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":12,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":86,"whyStopped":12,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Florida","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"C-Leg","NO_INTERVENTION","The first assessment will involve testing the participant with their current C-leg microprocessor prosthesis.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Bio Leg","EXPERIMENTAL","After the Bio Leg fitting, the participant will exclusively wear the Bio Leg knee component for an acclimation period that will be a minimum of 4 weeks and up to 6 depending on participant's schedule and comfort\u002Fease of using the device. Each participant will complete a minimum of 2 and up to 4 physical therapy sessions during the acclimation period. These physical therapy sessions will involve standard physical therapy training for use of a prosthetic limb after amputation. Following the acclimation period, the participant will complete the second assessment, which will mirror the first assessment.",[18],"Device: Bio-Leg",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Bio-Leg","After completing biomechanics and clinical testing at Pre Assessment with their C-Leg, participants will be fitted with a Bio-Leg prosthesis at the prosthetist clinic. The participant will train and use the Bio-Leg prosthesis during a 4-6 week acclimation period. The participant will then complete the same biomechanics and clinical testing at Post Assessment.",[14],[26],{"name":27,"affiliation":28,"role":29},"Emily J Fox, PT, DPT, MHS, PhD","University of Florida & Brooks Rehabilitation","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":12,"email":34},"CONTACT","904-742-2500","ejfox@phhp.ufl.edu",{"name":36,"role":32,"phone":37,"phoneExt":12,"email":38},"Joshua C Encarnacion, BS","904-345-8969","Joshua.Encarnacion@brooksrehab.org",[40],{"facility":41,"status":12,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":12},"Brooks Rehabilitation","Jacksonville","Florida","32216","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-81.65565,30.33218,{"lat":51,"lon":50},{"type":54,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[56],{"name":41,"class":6},"100637147","bio-leg-advancing-mobility-100637147",false,"NCT07613502","Bio Leg: Advancing Mobility","Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg","BAM","Inclusion Criteria:\n\n* Adults 40 to 70 years of age\n* Unilateral transfemoral amputation \\> 1 year\n* K3 or K4 ambulator and able to walk with no greater assistances than a single point cane\n* Current microprocessor-controlled prosthesis (C-leg) user with \\> 6 months experience and able to walk without a device of using a single point cane\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Severe cardiovascular condition or other disease limiting study participation\n* Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities\n* Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation\n* Pain that limits walking of participation in walking activities\n* Current participation in rehabilitation to address walking function","ALL","40 Years","70 Years",{"count":69,"type":70},12,"ESTIMATED","INTERVENTIONAL",[73],"NA","Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.",[76,77,78],"Amputation of Lower Limb Above Knee","Amputee","Amputation",[78,80,81,82,83,84,85,77],"Above Knee Amputation","AKA","Prosthetic Use","Prostheses","C-leg","BioLeg","NOT_YET_RECRUITING","2026-05-21",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":70},"2026-06-01",{"date":94,"type":70},"2028-07",{"name":5,"class":6},1]