[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651914":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":32,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":10,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":72,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Ischial Containment Socket user",null,"Person with unilateral transfemoral amputation wearing an ischial containment socket",{"label":13,"type":10,"description":14,"interventionNames":10},"Sub-Ischial Socket user","Person with unilateral transfemoral amputation wearing a sub-ischial socket",{"label":16,"type":10,"description":17,"interventionNames":10},"Able-bodied control","Person without an amputation",[19],{"name":20,"affiliation":21,"role":22},"Rebecca Stine, MS","Jesse Brown VA Medical Center, Chicago, IL","PRINCIPAL_INVESTIGATOR",[24,28],{"name":20,"role":25,"phone":26,"phoneExt":10,"email":27},"CONTACT","(312) 503-5726","rebecca.stine@va.gov",{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},"Steven A Gard, PhD","(312) 503-5718","steven.gard@va.gov",[33],{"facility":21,"status":10,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Chicago","Illinois","60612","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-87.65005,41.85003,{"lat":43,"lon":42},[46,47,48],{"name":20,"role":25,"phone":26,"phoneExt":10,"email":27},{"name":29,"role":25,"phone":30,"phoneExt":10,"email":31},{"name":20,"role":22,"phone":10,"phoneExt":10,"email":10},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651914","a-comparison-between-ischial-containment-and-sub-ischial-prosthetic-sockets-to-determine-their-effects-on-secondary-health-conditions-100651914",false,"NCT07768072","A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions","Inclusion Criteria:\n\nFor all participants:\n\n* Ability to complete the experimental protocol without undue fatigue or health risks\n* Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)\n\nIn addition for persons with lower limb amputation:\n\n* Prosthesis user for a minimum of 2 years with their current socket design\n* Good fit with either an ischial containment (IC) or sub-ischial (SI) socket\n* Good skin integrity on their residual limb upon visual inspection\n* Does not require the use of assistive devices to walk\n\nExclusion Criteria:\n\n* Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)\n* Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)",true,"ALL","18 Years","70 Years",{"count":62,"type":63},45,"ESTIMATED","OBSERVATIONAL","Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.",[67],"Unilateral Transfemoral Amputation",[69,70,71],"transfemoral amputation","prosthetic socket design","low back pain","NOT_YET_RECRUITING","2026-08-12",{"date":75,"type":76},"2026-08-17","ACTUAL",{"date":78,"type":63},"2027-01-01",{"date":80,"type":63},"2030-12-31",{"name":5,"class":6},1]