[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579773":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":59,"centralContacts":66,"locations":77,"responsibleParty":111,"collaborators":38,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":38,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":38,"enrollmentInfo":122,"targetDuration":38,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":137,"overallStatus":98,"whyStopped":38,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Holland Bloorview Kids Rehabilitation Hospital","OTHER",[8,16,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wear","ACTIVE_COMPARATOR","Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.",[13,14,15],"Device: Part A First Wear Period: Traditional AFO(s)","Device: Part A Second Wear Period: Digital AFO(s)","Device: Part B Long-term Evaluation Period: Traditional AFO(s)",{"label":17,"type":18,"description":19,"interventionNames":20},"Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wear","EXPERIMENTAL","Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.",[21,22,23],"Device: Part A First Wear Period: Digital AFO(s)","Device: Part A Second Wear Period: Traditional AFO(s)","Device: Part B Long-term Evaluation Period: Digital AFO(s)",{"label":25,"type":10,"description":26,"interventionNames":27},"Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wear","Participants wear traditionally produced AFO(s) for 3 weeks, and will then crossover to wear digital AFO(s) for another 3 weeks. In Part B of the study, participants will wear digital AFO(s) for 8 weeks.",[13,14,23],{"label":29,"type":10,"description":30,"interventionNames":31},"Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wear","Participants wear digitally produced AFO(s) for 3 weeks, and will then crossover to wear traditional AFO(s) for another 3 weeks. In Part B of the study, participants will wear traditional AFO(s) for 8 weeks.",[21,22,15],[33,39,43,47,51,55],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Part A First Wear Period: Traditional AFO(s)","Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.",[25,9],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Part A First Wear Period: Digital AFO(s)","Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.",[17,29],{"type":34,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"Part A Second Wear Period: Traditional AFO(s)","Participants wear traditionally produced AFOs during Weeks 4 through 6.",[17,29],{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"Part A Second Wear Period: Digital AFO(s)","Participants wear digitally produced AFOs during Weeks 4 through 6.",[25,9],{"type":34,"name":52,"description":53,"armGroupLabels":54,"otherNames":38},"Part B Long-term Evaluation Period: Traditional AFO(s)","Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.",[29,9],{"type":34,"name":56,"description":57,"armGroupLabels":58,"otherNames":38},"Part B Long-term Evaluation Period: Digital AFO(s)","Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.",[17,25],[60,64],{"name":61,"affiliation":62,"role":63},"Jan Andrysek, P.Eng, PhD","Bloorview Research Institute","PRINCIPAL_INVESTIGATOR",{"name":65,"affiliation":62,"role":63},"Virginia Wright, PT, PhD",[67,73],{"name":68,"role":69,"phone":70,"phoneExt":71,"email":72},"Calvin Ngan, PhD","CONTACT","416-425-6220","6340","cngan@hollandbloorview.ca",{"name":74,"role":69,"phone":70,"phoneExt":75,"email":76},"Gloria Lee, MSc","3342","glee@hollandbloorview.ca",[78,97],{"facility":79,"status":80,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Boundless Biomechanical Bracing","NOT_YET_RECRUITING","Mississauga","Ontario","L4W5A8","Canada","CA",{"type":87,"coordinates":88},"Point",[89,90],-79.6583,43.5789,{"lat":90,"lon":89},[93],{"name":94,"role":69,"phone":95,"phoneExt":38,"email":96},"Anne Whitney, MSc","905-602-0650","anne@boundlessbracing.com",{"facility":5,"status":98,"city":99,"state":82,"zip":100,"country":84,"countryCode":85,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"RECRUITING","Toronto","M4G1R8",{"type":87,"coordinates":102},[103,104],-79.39864,43.70643,{"lat":104,"lon":103},[107,108,109,110],{"name":68,"role":69,"phone":70,"phoneExt":71,"email":72},{"name":74,"role":69,"phone":70,"phoneExt":75,"email":76},{"name":61,"role":63,"phone":38,"phoneExt":38,"email":38},{"name":65,"role":63,"phone":38,"phoneExt":38,"email":38},{"type":112,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100579773","comparing-digitally-and-traditionally-made-ankle-foot-orthoses-100579773",false,"NCT06828653","Comparing Digitally and Traditionally Made Ankle Foot Orthoses","Feasibility RCT Evaluating Digitally and Traditionally Produced Ankle Foot Orthoses for Individuals With Impaired Lower Limb Function","Inclusion Criteria:\n\n* Participants must be aged 8 years or older.\n* Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments.\n* Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral).\n* Participants must be able to ambulate independently, though the use of gait aids is permitted.\n* Participants must be capable of completing questionnaires with no more than orienting guidance.\n* Participants must meet the requirements to have their AFO funded by the Assistive Devices Program (ADP).\n\nExclusion Criteria:\n\n* Clients for whom the primary goal of the AFO includes wound management.\n* Those whose AFO is not worn for ambulation.\n* Clients with insensate feet or a history of ulcerations.\n* First-time AFO users.","ALL","8 Years",{"count":123,"type":124},50,"ESTIMATED","INTERVENTIONAL",[127],"NA","The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.",[130,131,132,133,134,135,136],"Flaccid Paresis","Spastic Paresis","Cerebral Palsy","Stroke","Spinal Cord Injury","Spina Bifida","Traumatic Peripheral Nerve Injury",[138,139,140,141,142,143,144],"Ankle foot orthosis","ankle foot orthoses","digital ankle foot orthoses","digital technology","3D scanning","3D printing","randomized control trial","2025-11-18",{"date":147,"type":148},"2025-11-20","ACTUAL",{"date":150,"type":148},"2025-09-05",{"date":152,"type":124},"2027-03-31",{"name":5,"class":6},2]