Actively Recruiting
A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-05-07
18
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ways to improve the daily lives and treatment results of teenagers with Adolescent Idiopathic Scoliosis (AIS). Many young patients find wearing a corrective spinal brace for over 20 hours a day uncomfortable and stressful, which often leads to poor compliance and emotional challenges. This study evaluates a new integrated "Product System" designed to make wearing the brace a more supportive and engaging experience by using real-time monitoring and interactive feedback. The system includes thin-film pressure sensors embedded in the brace to monitor wear time and fit without reducing comfort. An interactive desktop terminal provides narrative-driven feedback and rewards to encourage adherence. A mobile app allows participants and parents to track progress, access educational materials, and communicate with healthcare providers. Participants will be assigned to either this digital support system or to standard care with manual logging of brace use and routine clinical support. Participants will use the system during daily life at home and school while researchers collect objective data on brace wear and subjective data through the Intrinsic Motivation Inventory to assess changes in motivation and psychological well-being. The study measures brace adherence and motivation over four weeks, aiming to reduce the medical burden and help teenagers feel more in control of their treatment. The trial is double-blinded, randomized, and runs until October 2026.
CONDITIONS
Brief Title
Support System Design for Adolescent Scoliosis Orthosis Wear
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Currently prescribed a spinal brace such as Boston or Milwaukee brace
- Aged between 10 and 18 years at enrollment
- Able to read, understand, and complete the Intrinsic Motivation Inventory (IMI) and other study questionnaires
- Access to a stable home Wi-Fi or local network for the interactive desktop terminal
- Participant willing to provide assent and legal guardian able to provide written informed consent
You will not qualify if you...
- Secondary scoliosis caused by neuromuscular, congenital, or syndromic conditions like cerebral palsy or Marfan syndrome
- Scheduled spinal surgery during the study period
- Severe skin allergies or chronic skin conditions at brace contact sites that could worsen from sensor use
- Previous participation in similar digital scoliosis intervention studies
- Diagnosed cognitive impairments or severe psychological disorders affecting reporting or product use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants wear spinal braces with or without the integrated digital support system. Those in the experimental arm use sensors and interactive feedback tools, while the control group follows conventional brace wear with manual logging. Psychological motivation is periodically assessed.
Baseline visit and periodic follow-up visits during the 4 weeks
Trial Site Locations
Total: 1 location
1
Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200140
Actively Recruiting
Research Team
D
Dian Zhu, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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