[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100308230":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":31,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":36,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Columbia University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Feedback Group","EXPERIMENTAL","Participants will receive the standard-of-care scoliosis brace fitted with the compliance-monitoring study device and\u002For a temperature monitor (Orthotimer or iButton). The physician or a member of the research team will explain how the study device works to the patient and her\u002Fhis parent. The physician or member of the research team will also explain the feedback mechanisms that exist to inform the patient that s\u002Fhe has fit the device to the clinician-indicated appropriate tension and the online component of the program that allows for brace tension monitoring.",[13],"Device: NYRC Brace Scoliosis Monitor",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","NYRC Brace Scoliosis Monitor","Scoliosis Monitor is a system that allows the continuous monitoring of the scoliosis brace use compliance and posture. This product includes a brace wearable that enables the monitoring of the scoliosis brace. The wearable device is able to communicate with a companion mobile application which stores and processes the collected data and is responsible for data synchronization.",[9],[21],"Monitor",[23],{"name":24,"affiliation":5,"role":25},"Benjamin Roye, MD, MPH","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Benjamin D. Roye, MD, MPH","CONTACT","(212) 305-5475",null,"bdr5@columbia.edu",[34],{"facility":35,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Morgan Stanley Children's Hospital of NY Presbyterian\u002FColumbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-74.00597,40.71427,{"lat":45,"lon":44},[48,52],{"name":49,"role":29,"phone":50,"phoneExt":31,"email":51},"Mehdi Elfilali, BA","212-305-9367","Mme2145@cumc.columbia.edu",{"name":53,"role":29,"phone":54,"phoneExt":31,"email":55},"Nicole Bainton","212-305-5475","nme2103@cumc.columbia.edu",{"type":57,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[59],{"name":60,"class":6},"Pediatric Orthopaedic Society of North America","100308230","brace-monitoring-for-adolescent-idiopathic-scoliosis-ais-100308230",false,"NCT03292601","Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)","Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment","Inclusion Criteria:\n\n* Diagnosis of Adolescent Idiopathic Scoliosis (AIS)\n* Sanders skeletal stage 4 or earlier\n* Clinician-recommended Rigo bracing\n* Patient receiving brace treatment\n\nExclusion Criteria:\n\n\\- Prior spine surgery","FEMALE","8 Years","17 Years",{"count":72,"type":73},87,"ESTIMATED","INTERVENTIONAL",[76],"NA","The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace.\n\nAdditionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.",[79],"Adolescent Idiopathic Scoliosis",[81,82],"Spinal Orthosis","Spinal Brace","2026-03-30",{"date":85,"type":86},"2026-04-03","ACTUAL",{"date":88,"type":86},"2017-10-18",{"date":90,"type":73},"2027-02",{"name":5,"class":6},1]