[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630741":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":23,"locations":18,"responsibleParty":28,"collaborators":31,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":18,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"University of Washington","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Individuals with transfemoral amputation","Prosthetic socket fit testing system",[12],"Device: Prosthetic socket fit testing system",[14],{"type":15,"name":10,"description":16,"armGroupLabels":17,"otherNames":18},"DEVICE","Prosthetic socket fit testing system to assess socket-limb coupling using movement error and duration.",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Stefania Fatone, PhD, BPO(Hons)","PRINCIPAL_INVESTIGATOR",[24],{"name":21,"role":25,"phone":26,"phoneExt":18,"email":27},"CONTACT","206-685-7918","sfaton@uw.edu",{"type":22,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Stefania Fatone","Professor, Department of Rehabilitation Medicine",[32],{"name":33,"class":34},"National Center for Advancing Translational Sciences (NCATS)","NIH","100630741","prosthetic-socket-fit-testing-system-100630741",false,"NCT07491614","Prosthetic Socket Fit Testing System","Evaluation of a Prototype Socket Fit Testing System to Assess Coupling of the Prosthetic Socket in Individuals With Lower Limb Amputation","Inclusion Criteria:\n\n* be between 18 and 70 years old\n* have a unilateral transfemoral amputation\n* be at least 12 months post-amputation\n* have a residual limb that is free of open wounds or infections\n* wear a prosthesis for a minimum of four hours per day\n* be able to ambulate short distances with a prosthesis\n* be able to stand on the intact leg for brief periods\n* be able to hold onto parallel bars with the arms for balance\n* have pain-free range of motion at the hip on the amputated side\n* have no back problems that make standing or hip movement difficult\n* have corrected vision that is sufficient to see the cursors on the screen\n* be able to follow simple instructions in English\n\nExclusion Criteria:\n\n* residual limb issues (e.g. sensitive or frail skin) that may be made worse by testing\n* a prosthetic socket that cannot be disconnected from the distal prosthetic components\n* unable to read and speak English","ALL","18 Years","70 Years",{"count":46,"type":47},18,"ESTIMATED","INTERVENTIONAL",[50],"NA","Ensuring a well fitting prosthetic socket is a major challenge in the care of people with amputation. Poor fit causes pain, skin issues, reduced mobility, and lower satisfaction, affecting daily activity and quality of life. Current prosthetic socket fit assessment relies on prosthesis user feedback, prosthetist experience or intrusive equipment. The investigators have developed a non-invasive prototype socket fit testing system that attaches externally to the end of any prosthetic socket and uses two air cylinders to apply resistance and track motion. During testing, socket motion is mapped to a cursor on a screen. Participants perform a test where they move their leg and socket to randomly presented targets. Movement duration and accuracy provide measures of how well the socket and leg move together. This pilot study will assess feasibility and validity of the socket fit testing system performance for above-the-knee prosthesis users.",[53],"Amputation",[55,56,57],"prosthesis","assessment","socket fit","NOT_YET_RECRUITING","2026-03-18",{"date":61,"type":62},"2026-03-24","ACTUAL",{"date":64,"type":47},"2026-04-01",{"date":66,"type":47},"2027-02-28",{"name":5,"class":6}]