[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588119":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":66,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":19,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":19,"enrollmentInfo":82,"targetDuration":19,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Hanger Institute for Clinical Research and Education, LLC","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"MPK (Ottobock C-Leg 4 or Ottobock Kenevo)","EXPERIMENTAL","The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria.",[13,14],"Device: Ottobock C-Leg 4 Microprocessor Knee","Device: Ottobock Kenevo",{"label":16,"type":17,"description":18,"interventionNames":19},"nMPK","NO_INTERVENTION","Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DEVICE","Ottobock C-Leg 4 Microprocessor Knee","Subjects in the intervention group who can walk more than 0.83m\u002Fs in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Ottobock Kenevo","Subjects in the intervention group who can walk up to 0.83m\u002Fs (3km\u002Fhr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.",[9],[31],{"name":32,"affiliation":33,"role":34},"Shane R. Wurdeman, PhD","Hanger Institute for Clinical Research and Education","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":19,"email":39},"CONTACT","281-829-4746","swurdeman@hanger.com",{"name":41,"role":37,"phone":42,"phoneExt":19,"email":43},"Bretta L. Fylstra, PhD","512-994-6685","bfylstra@hanger.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Hanger Inc.","RECRUITING","Austin","Texas","78758","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-97.74306,30.26715,{"lat":57,"lon":56},[60,61,63],{"name":32,"role":37,"phone":38,"phoneExt":19,"email":39},{"name":62,"role":37,"phone":42,"phoneExt":19,"email":43},"Bretta L. Fystra, PhD",{"name":32,"role":34,"phone":19,"phoneExt":19,"email":19},{"type":65,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[67,70],{"name":68,"class":69},"University of Washington","OTHER",{"name":71,"class":72},"U.S. Army Medical Research Acquisition Activity","FED","100588119","effects-of-microprocessor-controlled-prosthetic-knees-on-fall-related-health-outcomes-in-limited-community-ambulators-100588119",false,"NCT06937242","Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators","Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees","Inclusion Criteria:\n\n* Unilateral transfemoral or knee disarticulation limb loss.\n* 6 months or longer since time of limb loss.\n* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.\n* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.\n* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).\n* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:\n\n  1. Houghton Score: 5-10\n  2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease\u002Fdiabetes \\\u003C49.45, otherwise, \\\u003C36.75.\n  3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months\n* Ability to read, write, and understand English.\n\nExclusion Criteria:\n\n* Any health condition that would prevent safely completing trial activities.\n* Any individuals that weigh 275 lbs or more.\n* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week\n* Individuals with a history of acute or chronic residual limb breakdown\n* Individuals with declining health status such that he\u002Fshe subsequently reports reduced activity over the past 6 months","ALL","18 Years",{"count":83,"type":84},100,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:\n\n* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?\n* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?\n\nParticipants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.",[90,91,92,93,94,95],"Amputation","Prosthesis User","Amputation; Traumatic, Leg: Thigh, Between Hip and Knee","Limb; Absence, Congenital, Lower","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation Above Knee",[97,98,99,100,101,102,103,104,105,106,107,108,109],"amputation","lower limb amputation","lower limb prosthesis user","mechanical knee","microprocessor knee","transfemoral amputation","knee disarticulation","prosthetic knee","falls","falling","amputee","transfemoral amputee","MPK","2026-02-03",{"date":112,"type":113},"2026-02-05","ACTUAL",{"date":115,"type":113},"2025-07-11",{"date":117,"type":84},"2027-02",{"name":5,"class":6},1]