[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546544":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":45,"responsibleParty":132,"collaborators":25,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":138,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":25,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exergaming Intervention for 8 Weeks","EXPERIMENTAL","Extension Phase: Participants randomized ot the intervention arm will play Tales from the Magic Keep at home for the 8 week open-label extension phase",[13],"Other: Tales from the Magic Keep™",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care for 8 weeks.","ACTIVE_COMPARATOR","Extension Phase: Participants randomized to waitlist usual care will play Tales from the Magic Keep at home for the 8 week open-label extension phase",[19],"Other: Usual Care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Tales from the Magic Keep™","Exergame targeting upper limb and trunk movement designed for use on the Microsoft Azure Kinect Dose: At least 3 times a week for 20 minutes over 8 weeks (8 hours total) Continue with regularly accessed physical activities and rehabilitation services",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","Continue with regularly accessed physical activities and rehabilitation services",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Maryam Oskoui","McGill University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Danielle Levac","Université de Montréal",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Mbaye Ndiaye","CONTACT","5149341934","37299","mbaye.ndiaye@muhc.mcgill.ca",[46,67,83,99,116],{"facility":47,"status":48,"city":49,"state":50,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Alberta Children's Hospital","RECRUITING","Calgary","Alberta","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-114.08529,51.05011,{"lat":57,"lon":56},[60,65],{"name":61,"role":41,"phone":62,"phoneExt":63,"email":64},"Julie Dao","403-955-7211","7132","Julie.dao@ucalgary.ca",{"name":66,"role":34,"phone":25,"phoneExt":25,"email":25},"Jean Mah",{"facility":68,"status":48,"city":69,"state":70,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"BC Children's Hospital","Vancouver","British Columbia",{"type":54,"coordinates":72},[73,74],-123.11934,49.24966,{"lat":74,"lon":73},[77,81],{"name":78,"role":41,"phone":79,"phoneExt":63,"email":80},"Alex Salvarinov","604 875 2345","alex.salvarinov@cw.bc.ca",{"name":82,"role":34,"phone":25,"phoneExt":25,"email":25},"Kathryn Selby",{"facility":84,"status":48,"city":85,"state":86,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"IWK Health Services","Halifax","Nova Scotia",{"type":54,"coordinates":88},[89,90],-63.57688,44.64269,{"lat":90,"lon":89},[93,97],{"name":94,"role":41,"phone":95,"phoneExt":25,"email":96},"Sara Drisdelle","902-789-1599","sara.drisdelle@iwk.nshealth.ca",{"name":98,"role":34,"phone":25,"phoneExt":25,"email":25},"Jordan Sheriko",{"facility":100,"status":48,"city":101,"state":102,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Hospital for SickKids","Toronto","Ontario",{"type":54,"coordinates":104},[105,106],-79.39864,43.70643,{"lat":106,"lon":105},[109,114],{"name":110,"role":41,"phone":111,"phoneExt":112,"email":113},"Ana Stosic","416-813-7654","309965","ana.stosic@sickkids.ca",{"name":115,"role":34,"phone":25,"phoneExt":25,"email":25},"Hernan Gonorazky",{"facility":117,"status":48,"city":118,"state":119,"zip":25,"country":51,"countryCode":52,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Centre de readaptation Marie-Enfant","Montreal","Quebec",{"type":54,"coordinates":121},[122,123],-73.58781,45.50884,{"lat":123,"lon":122},[126,131],{"name":127,"role":41,"phone":128,"phoneExt":129,"email":130},"Evemie Dube","514 374-1710","8601","evemie.dube.hsj@ssss.gouv.qc.ca",{"name":36,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":133,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Maryam Oskoui, MD, MSc, FRCPC, FAAN","Full Professor, Department of Pediatrics and Neurology & Neurosurgery","100546544","a-registry-based-randomized-controlled-trial-of-an-upper-limb-exergaming-intervention-for-children-and-adolescents-with-spinal-muscular-atrophy-100546544",false,"NCT06396325","A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy","A Registry-Based Parallel Group Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy, With an Optional Open-Label Extension","INFORM SMA","Inclusion Criteria:\n\n* Confirmed genetic diagnosis of 5q SMA\n* Age at screening: Aged 8-18 years old\n* Participant is able to stay seated independently without support for at least 10 seconds\n* Participants has a score of at least 2 points in entry item A of the RULM (i.e., \"Can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth\")\n* Treated with disease-modifying therapy\n* Signed ICF\n\nExclusion Criteria:\n\n* Inability to comply with study procedures according to the site investigator, prior to randomization\n* Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator\n* Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)\n* Inability to read in English or French","ALL","8 Years","18 Years",{"count":148,"type":149},22,"ESTIMATED","INTERVENTIONAL",[152],"NA","This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA).",[155],"Spinal Muscular Atrophy",[157,158,159,160,161],"spinal muscular atrophy","rehabilitation","Exergaming","Pediatrics","Randomized-controlled trial","2025-07-03",{"date":164,"type":165},"2025-07-08","ACTUAL",{"date":167,"type":165},"2024-11-01",{"date":169,"type":149},"2027-12-31",{"name":134,"class":6},5]