NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear
| NCT ID | NCT07574229 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | Adolescent Idiopathic Scoliosis (AIS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2026-02-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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/Enjoyment, Perceived Competence, and Pressure/Tension-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/IMI 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.
Eligibility Criteria
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.
Contact & Investigator
Zhao Liu
PRINCIPAL INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT07574229 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying Adolescent Idiopathic Scoliosis (AIS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07574229 currently recruiting?
Yes, NCT07574229 is actively recruiting participants. Contact the research team at zhudian@sjtu.edu.cn for enrollment information.
Where is the NCT07574229 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07574229 clinical trial?
NCT07574229 is sponsored by Shanghai Jiao Tong University School of Medicine. The principal investigator is Zhao Liu at Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 18 participants.