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Support System Design for Adolescent Scoliosis Orthosis Wear

RecruitingNAAges 10 Years - 18 YearsAllShanghai Jiao Tong University School of Medicine
NCT07574229 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 intui

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📋 Eligibility rules (as published)
Eligibility Criteria Inclusion Criteria: Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS). Current orthotic treatment with a prescription for a spinal brace (e.g., Boston, Milwaukee, or similar corrective braces). Between 10 and 18 years of age at the time of enrollment. Ability to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study-related questionnaires. Access to a stable home environment with Wi-Fi or local network connectivity for the interactive desktop terminal. Willingness of the participant to provide assent and the legal guardian to provide written informed consent. Exclusion Criteria: Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions (e.g., cerebral palsy or Marfan syndrome). Scheduled spinal surgery within the planned study period. Severe skin allergies or chronic dermatological conditions at the brace contact sites that might be aggravated by sensor integration. Previous participation in similar digital intervention studies for scoliosis management. Diagnosed cognitive impairments or severe psychological disorders that may interfere with accurate reporting or regular use of the product system.
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What it tests

  • Digital Support System for AIS Orthosis Wear
  • Conventional Treatment Control Group
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Where

1 site
Shanghai Jiao Tong University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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