[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569318":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":42,"centralContacts":51,"locations":60,"responsibleParty":127,"collaborators":131,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":42,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":42,"enrollmentInfo":147,"targetDuration":42,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":42,"overallStatus":63,"whyStopped":42,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",[8,16,20,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"PF-CS-MA","EXPERIMENTAL","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the carbon strut (CS) AFO, and finally the multifunctional articulating (MA) AFO.",[13,14,15],"Device: Pre-fabricated (PF) ankle-foot orthosis (AFO)","Device: Carbon-strut (CS) ankle-foot orthosis (AFO)","Device: Multifunctional articulating (MA) ankle-foot orthosis (AFO)",{"label":17,"type":10,"description":18,"interventionNames":19},"PF-MA-CS","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the pre-fabricated (PF) AFO, followed by the multifunctional articulating (MA) AFO, and finally the carbon strut (CS) AFO.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"CS-PF-MA","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the pre-fabricated (PF) AFO, and finally the multifunctional articulating (MA) AFO.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"CS-MA-PF","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the carbon strut (CS) AFO, followed by the multifunctional articulating (MA) AFO, and finally the pre-fabricated (PF) AFO.",[13,14,15],{"label":29,"type":10,"description":30,"interventionNames":31},"MA-PF-CS","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the pre-fabricated (PF) AFO, and finally the carbon strut (CS) AFO.",[13,14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"MA-CS-PF","Participants will wear each of the three ankle-foot orthosis (AFO) treatment options over three separate four-week periods. In this arm, participants first use the multifunctional articulating (MA) AFO, followed by the carbon strut (CS) AFO, and finally the pre-fabricated (PF) AFO.",[13,14,15],[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Pre-fabricated (PF) ankle-foot orthosis (AFO)","These pre-manufactured orthoses are customized to fit each patient. These devices can help to distribute weight evenly along the foot, but do not offer much opportunity for adjustment to a patient's specific needs. These AFOs achieve ankle motion through material deflection and lack a single point of articulation.",[25,21,33,29,9,17],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Carbon-strut (CS) ankle-foot orthosis (AFO)","These AFO designs are built from a custom mold of the patient's affected limb for a more individualized fit. It includes a solid ankle design and achieves ankle motion through material deflection and lacks a single point of articulation.",[25,21,33,29,9,17],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Multifunctional articulating (MA) ankle-foot orthosis (AFO)","These AFO designs are also built from a custom mold of the patient's affected limb, but these orthoses have a true articulation at the ankle to provide controlled ankle movement in a range determined appropriate by the orthotist through gait analysis.",[25,21,33,29,9,17],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":42,"email":56},"Richard R Neptune, PhD","CONTACT","512-471-0848","rneptune@mail.utexas.edu",{"name":58,"role":54,"phone":42,"phoneExt":42,"email":59},"Shelby L Walford, PhD","shelbywalford@utexas.edu",[61,81,96,112],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Rancho Research Institute","RECRUITING","Downey","California","90242","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-118.13257,33.94001,{"lat":73,"lon":72},[76,80],{"name":77,"role":54,"phone":78,"phoneExt":42,"email":79},"Jeffery Rankin, PhD","562-385-7177","jrankin@ranchoresearch.org",{"name":42,"role":54,"phone":42,"phoneExt":42,"email":79},{"facility":82,"status":63,"city":83,"state":84,"zip":85,"country":67,"countryCode":68,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Brooks Rehabilitation","Jacksonville","Florida","32216",{"type":70,"coordinates":87},[88,89],-81.65565,30.33218,{"lat":89,"lon":88},[92],{"name":93,"role":54,"phone":94,"phoneExt":42,"email":95},"Mark Bowden, PhD","352-318-2779","mark.bowden@Brooksrehab.org",{"facility":97,"status":63,"city":98,"state":99,"zip":100,"country":67,"countryCode":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":70,"coordinates":102},[103,104],-79.93275,32.77632,{"lat":104,"lon":103},[107,111],{"name":108,"role":54,"phone":109,"phoneExt":42,"email":110},"Steve Kautz, PhD","843-792-3867","kautz@musc.edu",{"name":42,"role":54,"phone":42,"phoneExt":42,"email":110},{"facility":113,"status":63,"city":114,"state":115,"zip":116,"country":67,"countryCode":68,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hanger Clinic","Houston","Texas","77025",{"type":70,"coordinates":118},[119,120],-95.36327,29.76328,{"lat":120,"lon":119},[123],{"name":124,"role":54,"phone":125,"phoneExt":42,"email":126},"Shane Wurdeman, PhD","402-290-8051","swurdeman@hanger.com",{"type":128,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Rick Neptune","Professor",[132,133,135,137],{"name":97,"class":6},{"name":134,"class":6},"Rancho Los Amigos National Rehabilitation Center",{"name":136,"class":6},"Hanger Clinic: Prosthetics & Orthotics",{"name":82,"class":6},"100569318","afo-prescription-to-optimize-post-stroke-function-100569318",false,"NCT06692686","AFO Prescription to Optimize Post-Stroke Function","The Development of Patient-Centered Clinical AFO Prescription Guidelines to Optimize Post-Stroke Function and Quality of Life","Inclusion Criteria:\n\n* be a minimum of three months post-stroke\n* be greater than 18 years of age\n* have been prescribed either a semi-rigid or a custom-made articulating AFO\n* wear their prescribed AFO for all primary mobility activity outside the house\n* be able to walk at least 20 meters without manual assistance\n* walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test.\n\nExclusion Criteria:\n\n* having a condition that could significantly limit ambulation, including severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or pre-existing neurological disorder other than post-stroke\n* having cognitive deficits that preclude their ability to provide consent for participation\n* having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension","ALL","18 Years",{"count":148,"type":149},120,"ESTIMATED","INTERVENTIONAL",[152],"NA","The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will:\n\n1. Identify the factors that significantly contribute to an individual's highest potential quality of life when considering each of the three available AFO design options, and\n2. Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs.\n\nParticipants will be asked to:\n\n* Wear each of the three modern AFO designs for one month, after receiving therapy training and\n* Complete questionnaires and performance tests with each AFO.\n\nIn addition, the subset of individuals participating in goal 2) will also be asked to:\n\n* Perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.",[155,156,157],"Ankle Foot Orthosis (AFO)","Stroke Patients","Post-Stroke Hemiparesis","2025-08-15",{"date":160,"type":161},"2025-08-21","ACTUAL",{"date":163,"type":161},"2025-07-08",{"date":165,"type":149},"2027-10",{"name":5,"class":6},4]