[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ankle-foot-orthosis-afo\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ankle-foot-orthosis-afo":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100525863","reliability-of-force-measurement-within-the-carbon-fiber-orthosis-proximal-cuff-100525863",false,"NCT06127264","Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff","CuffForce","Group 1 - Able Bodied Participants\n\nInclusion Criteria\n\n* Between the ages of 18 and 65\n* Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months\n* Able to hop without pain\n* Able to perform a full squat without pain\n* Ability to read and write in English and provide written informed consent\n* Ability to fit in a generic sized CDO\n\nExclusion Criteria\n\n* Diagnosed with a moderate or severe brain injury\n* Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks\n* Injuries that would limit performance in this study\n* Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* Require use of an assistive device\n* Unhealed wounds (cuts\u002Fabrasions) that would prevent AFO use\n* BMI \\> 40\n* Pregnancy\n\nGroup 2 - AFO Users without Peripheral Neuropathy\n\nInclusion Criteria:\n\n* Between the ages of 18 and 90\n* Use an AFO(s) for daily activities\n* The AFO(s) proximal cuff is compatible with loadpad sensors\n* Have used their AFO(s) for a minimum of 2 weeks\n* Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)\n* Ability to read and write in English and provide written informed consent\n\nExclusion Criteria\n\n* Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments\n* Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)\n* Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* BMI \\> 40\n* Pregnancy\n\nGroup 3 - AFO Users with Peripheral Neuropathy\n\nInclusion Criteria:\n\n* Between the ages of 18 and 90\n* Use an AFO(s) for daily activities\n* The AFO(s) proximal cuff is compatible with loadpad sensors\n* Have used their AFO(s) for a minimum of 2 weeks\n* Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)\n* Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments\n* Ability to read and write in English and provide written informed consent\n\nExclusion Criteria\n\n* Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)\n* Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities\n* Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing\n* BMI \\> 40\n* Pregnancy",true,"ALL","18 Years","90 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education.\n\nStudy participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. .\n\nGroup 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness.\n\nFor all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.",[28,29,30],"Healthy","Ankle Foot Orthosis (AFO)","Peripheral Neuropathy",[32,33,34],"Ankle Foot Orthosis","Carbon Fiber Orthosis","Plantar Force","RECRUITING","2025-12-29",{"date":38,"type":39},"2025-12-31","ACTUAL",{"date":41,"type":39},"2024-03-01",{"date":43,"type":22},"2026-12-31",{"name":45,"class":46},"University of Iowa","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100569318","afo-prescription-to-optimize-post-stroke-function-100569318","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",{"count":56,"type":22},120,[25],"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.",[29,60,61],"Stroke Patients","Post-Stroke Hemiparesis","2025-08-15",{"date":64,"type":39},"2025-08-21",{"date":66,"type":39},"2025-07-08",{"date":68,"type":22},"2027-10",{"name":70,"class":46},"University of Texas at Austin",4]