[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638218":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Integrated Product System Intervention Arm","EXPERIMENTAL","Participants in this arm will use an integrated digital support system consisting of:\n\nSmart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution.\n\nInteractive Terminal: A desktop device for the home that converts sensor data into \"narrative-driven\" feedback with rewards.\n\nMobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction.\n\nPsychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction.",[13],"Device: Digital Support System for AIS Orthosis Wear",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Treatment Control Group","SHAM_COMPARATOR","Standard Care: Participants wear their conventional spinal braces according to their physician's prescription without any electronic monitoring or feedback devices.\n\nManual Logging: Adherence data (daily wear time) is recorded manually by patients or parents through paper diaries or self-reporting during follow-ups.\n\nRoutine Clinical Support: Participants receive standard medical education and attend scheduled physical examinations and adjustments.",[19],"Behavioral: Conventional Treatment Control Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Digital Support System for AIS Orthosis Wear","Smart Monitoring: Thin-film pressure sensors integrated into the brace to automatically record daily wear time and pressure distribution.\n\nInteractive Terminal: A desktop device for the home that converts sensor data into \"narrative-driven\" feedback (e.g., \"The Spine's Path\") with rewards.\n\nMobile App: A tool for patients and parents to track long-term trends, access educational content, and facilitate family interaction.\n\nPsychological Assessment: Participants will periodically complete the Intrinsic Motivation Inventory (IMI) to evaluate the system's impact on interest, competence, and pressure reduction.",[9],null,{"type":28,"name":15,"description":17,"armGroupLabels":29,"otherNames":26},"BEHAVIORAL",[15],[31],{"name":32,"affiliation":5,"role":33},"Zhao Liu","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Dian Zhu, Dr","CONTACT","+8618901626266","zhudian@sjtu.edu.cn",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Shanghai Jiao Tong University","RECRUITING","Shanghai","Shanghai Municipality","200140","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":32,"role":37,"phone":57,"phoneExt":26,"email":58},"18801971294","hotlz@sjtu.edu.cn",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zhu Dian","Principal Investigator","100638218","support-system-design-for-adolescent-scoliosis-orthosis-wear-100638218",false,"NCT07574229","Support System Design for Adolescent Scoliosis Orthosis Wear","A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback","Eligibility Criteria\n\nInclusion Criteria:\n\nClinical diagnosis of Adolescent Idiopathic Scoliosis (AIS).\n\nCurrent orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces).\n\nBetween 10 and 18 years of age at the time of enrollment.\n\nAbility to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires.\n\nAccess to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal.\n\nWillingness of the participant to provide assent and the legal guardian to provide written informed consent.\n\nExclusion Criteria:\n\nSecondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome).\n\nScheduled spinal surgery within the planned study period.\n\nSevere skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration.\n\nPrevious participation in similar digital intervention studies for scoliosis management.\n\nDiagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.","ALL","10 Years","18 Years",{"count":73,"type":74},18,"ESTIMATED","INTERVENTIONAL",[77],"NA","This study focuses on improving the daily lives and treatment outcomes of teenagers diagnosed with Adolescent Idiopathic Scoliosis (AIS). For many young patients, wearing a corrective brace for 20+ hours a day is physically uncomfortable and psychologically challenging, leading to low compliance and emotional distress.The investigators have developed an integrated \"Product System\" designed to transform the bracing experience from a burdensome task into a guided, supportive journey. This system consists of three main components:Smart Sensing: Discrete, thin-film pressure sensors are integrated into the existing brace to monitor real-time wear time and fit quality without compromising comfort.Interactive Desktop Terminal: A dedicated device for the home that uses \"narrative-driven\" feedback (themed around a journey called \"The Spine's Path\"). Instead of cold medical data, it provides intuitive progress visualizations and rewards to keep participants engaged.Mobile Support App: A tool for both participants and parents to track long-term trends, access educational resources, and facilitate communication with healthcare providers.The Goal of the Study The primary objective is to evaluate how this digital intervention affects a participant's \"Intrinsic Motivation\"-the internal drive to adhere to treatment. By focusing on three psychological dimensions-Interest\u002FEnjoyment, Perceived Competence, and Pressure\u002FTension-the investigators aim to determine if interactive feedback can reduce the \"medical feel\" of the brace and help teenagers feel more in control of the recovery.What Participation Involves Participants will use the product system during the daily routine in home and school environments. The investigators will collect objective data (brace usage hours) and subjective data (through the Intrinsic Motivation Inventory\u002FIMI scale) to measure changes in behavior and mental well-being.Benefits for Families and ProvidersFor Participants: A more engaging, less stressful way to manage the condition and see real-time progress.For Families: Reduced friction regarding brace-wearing and better visibility into the participant's treatment status.For Healthcare Providers: Access to accurate, objective data on participant compliance, allowing for more personalized and effective clinical adjustments.",[80,81],"Adolescent Idiopathic Scoliosis (AIS)","Adherence","2026-05-03",{"date":84,"type":85},"2026-05-07","ACTUAL",{"date":87,"type":85},"2026-02-01",{"date":89,"type":74},"2026-10-01",{"name":5,"class":6},1]