[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570659":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":34,"responsibleParty":63,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":12,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":50,"whyStopped":12,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"No Visual Feedback","NO_INTERVENTION","Participants will receive typical accommodation training after being prescribed the CDO.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Provided Visual Feedback","ACTIVE_COMPARATOR","Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO.",[18],"Other: Visual Feedback",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Visual Feedback","Visual feedback of foot loading during gait.",[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Jason M Wilken, PT, PhD","CONTACT","319-335-6857","jason-wilken@uiowa.edu",{"name":31,"role":27,"phone":32,"phoneExt":12,"email":33},"Kirsten M Anderson, PhD","319-353-0431","kirsten-m-anderson@uiowa.edu",[35,48],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":12},"ACTIVE_NOT_RECRUITING","Iowa City","Iowa","52241","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-91.53017,41.66113,{"lat":46,"lon":45},{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Cornerstone Prosthetics and Orthotics","RECRUITING","Everett","Washington","98225",{"type":43,"coordinates":55},[56,57],-122.20208,47.97898,{"lat":57,"lon":56},[60],{"name":61,"role":27,"phone":32,"phoneExt":12,"email":62},"Shawna Ziemer, CPO, LPO","wilkenlab@healthcare.uiowa.edu",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Jason Wilken","Associate Professor",[68],{"name":69,"class":70},"Cornerstone Clinics, Everett, WA","UNKNOWN","100570659","effect-of-custom-dynamic-orthoses-on-forefoot-loading-100570659",false,"NCT06710119","Effect of Custom Dynamic Orthoses on Forefoot Loading","LoadsolCP","Patient Inclusion criteria\n\n* Ages: 18-65\n* Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis\n* Shoe size between women's 8 and 13.5 or men's 6.5 and 13\n* Any of the following: weakness of ankle plantarflexors (\\\u003C4\u002F5 on MMT), limited pain free ankle motion (DF\\\u003C10deg or PF\\\u003C20deg), mechanical pain with loading onto hindfoot\u002Fmidfoot\u002Fforefoot (\\>4\u002F10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle\u002Ffoot impairment\n* Ability to walk 25 feet without using a cane or crutch\n* Ability to walk at a slow to moderate pace\n* Able to read and write in English and provide written informed consent\n\nPatient Exclusion criteria\n\n* Pain \\> 9\u002F10 while walking\n* Ankle weakness as a result of spinal cord injury or central nervous system pathology\n* AFO or CDO prescription that includes a knee brace or goes up to thigh\n* Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)\n* Nerve, muscle, bone, or other condition limiting function of the contralateral extremity\n* BMI greater than 40\n* Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing\n* Pregnancy","ALL","18 Years","65 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.",[89],"Lower Extremity Injuries",[91,92,93,94,21,95],"Gait Analysis","Ankle Foot Orthosis","Carbon Fiber","Biomechanics","Foot Loading","2025-12-29",{"date":98,"type":99},"2025-12-31","ACTUAL",{"date":101,"type":99},"2025-06-18",{"date":103,"type":83},"2027-12-31",{"name":5,"class":6},2]