[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543201":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":49,"centralContacts":53,"locations":63,"responsibleParty":135,"collaborators":139,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":153,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":57,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":66,"whyStopped":57,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"NoCDO, A, B, C","EXPERIMENTAL","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration B, and finally CDO configuration C.",[13,14],"Device: Modular Carbon Fiber Custom Dynamic Orthosis (CDO)","Device: Mono Carbon Fiber Custom Dynamic Orthosis (CDO)",{"label":16,"type":10,"description":17,"interventionNames":18},"NoCDO, A, C, B","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration A, CDO configuration C, and finally CDO configuration B.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"NoCDO, B, A, C","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration A, and finally CDO configuration C.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"NoCDO, B, C, A","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration B, CDO configuration C, and finally CDO configuration A.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"NoCDO, C, A, B","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration A, and finally CDO configuration B.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"NoCDO, C, B, A","Participants will first be evaluated without a CDO (NoCDO), then in CDO configuration C, CDO configuration B, and finally CDO configuration A.",[13,14],[36,43],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DEVICE","Modular Carbon Fiber Custom Dynamic Orthosis (CDO)","The CDO will use a modular design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.",[9,16,20,24,28,32],[42],"Reaktiv (Fabtech Systems LLC, Everett WA)",{"type":37,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Mono Carbon Fiber Custom Dynamic Orthosis (CDO)","The CDO will use a mono design that includes a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee.",[9,16,20,24,28,32],[48],"Posterior Spring (Bio-Mechanical Composites, Inc., Des Moines, IA)",[50],{"name":51,"affiliation":5,"role":52},"Jason M Wilken, PT, PhD","PRINCIPAL_INVESTIGATOR",[54,59],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","319-335-6857",null,"jason-wilken@uiowa.edu",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Molly S Pacha, MS, ATC, LAT","319-290-7596","molly-pacha@uiowa.edu",[64,82,94,108,121],{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Naval Medical Center San Diego - Clinical Biomechanics Laboratory","RECRUITING","San Diego","California","92134","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-117.16472,32.71571,{"lat":76,"lon":75},[79],{"name":80,"role":55,"phone":57,"phoneExt":57,"email":81},"Trevor Kingsbury, PhD","trevor.d.kingsbury.civ@health.mil",{"facility":5,"status":66,"city":83,"state":84,"zip":85,"country":70,"countryCode":71,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Iowa City","Iowa","52242",{"type":73,"coordinates":87},[88,89],-91.53017,41.66113,{"lat":89,"lon":88},[92,93],{"name":51,"role":55,"phone":56,"phoneExt":57,"email":58},{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},{"facility":95,"status":66,"city":96,"state":97,"zip":98,"country":70,"countryCode":71,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Minneapolis VA Health Care System - Motion Analysis Laboratory","Minneapolis","Minnesota","55417",{"type":73,"coordinates":100},[101,102],-93.26384,44.97997,{"lat":102,"lon":101},[105],{"name":106,"role":55,"phone":57,"phoneExt":57,"email":107},"John Looft, PhD","john.looft@va.gov",{"facility":109,"status":66,"city":110,"state":97,"zip":111,"country":70,"countryCode":71,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Mayo Clinic - Motion Analysis Lab","Rochester","55905",{"type":73,"coordinates":113},[114,115],-92.4699,44.02163,{"lat":115,"lon":114},[118],{"name":119,"role":55,"phone":57,"phoneExt":57,"email":120},"Kenton R Kaufman, PhD","Kaufman.Kenton@mayo.edu",{"facility":122,"status":66,"city":123,"state":124,"zip":125,"country":70,"countryCode":71,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology","Nashville","Tennessee","37212",{"type":73,"coordinates":127},[128,129],-86.78444,36.16589,{"lat":129,"lon":128},[132],{"name":133,"role":55,"phone":57,"phoneExt":57,"email":134},"Karl Zelik, PhD","karl.zelik@vanderbilt.edu",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"SPONSOR_INVESTIGATOR","Jason Wilken","Associate Professor",[140,142,144,147,149],{"name":141,"class":6},"Mayo Clinic",{"name":143,"class":6},"Vanderbilt University Medical Center",{"name":145,"class":146},"Navy Medical Center San Diego","FED",{"name":148,"class":146},"Minneapolis Veterans Affairs Medical Center",{"name":150,"class":6},"Johns Hopkins University","100543201","from-opinion-to-evidence-multi-site-evaluation-of-custom-dynamic-orthosis-best-practices-100543201",false,"NCT06352788","From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices","AFOSVA","Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* 2 or more years from a traumatic injury below the knee\n* Ability to be fit with an orthosis\n* Any of the following:\n\n  * Weakness of ankle plantarflexors (\\\u003C4\u002F5 on manual muscle test)\n  * Limited pain-free ankle motion (dorsiflexion (DF) \\\u003C10° or plantarflexion (PF) \\\u003C20°)\n  * Mechanical pain with loading to hindfoot\u002Fmidfoot (\\>=4\u002F10 Numerical pain rating scale)\n  * Fusion or candidate for fusion of the ankle or hindfoot\n  * Candidate for amputation secondary to ankle\u002Ffoot injury and impairment\n\nExclusion Criteria:\n\n* Pain greater than 8\u002F10 at rest\n* Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology\n* Use of an orthosis including the knee\n* Non-ambulatory\n* Surgery on study limb anticipated in next 4 months\n* Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)\n* Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity\n* Uncorrected visual or hearing impairments\n* Pregnancy\n* Non-English speaking\n* BMI \\> 40","ALL","18 Years","65 Years",{"count":162,"type":163},35,"ESTIMATED","INTERVENTIONAL",[166],"NA","This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury.",[169],"Foot Injury",[171,172,173,174,175],"Ankle Foot Orthosis","Carbon Fiber","Gait","Biomechanics","Physical Performance","2026-01-13",{"date":178,"type":179},"2026-01-15","ACTUAL",{"date":181,"type":179},"2024-07-02",{"date":183,"type":163},"2028-09-01",{"name":137,"class":6},5]