Support system to make brace wear easier for teens with scoliosis

A Product System Intervention Study on Improving Wear Compliance and Psychological Motivation for Adolescent Idiopathic Scoliosis Patients Based on Sensory Monitoring and Interactive Feedback

This project will test a combined sensor, home terminal, and mobile app system to help teenagers with adolescent idiopathic scoliosis wear their corrective brace more comfortably and consistently.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07574229 on ClinicalTrials.gov

What this trial studies

The intervention integrates thin-film pressure sensors into standard spinal braces to measure real-time wear time and fit without adding bulk. At home, participants use an interactive desktop terminal that provides narrative-driven feedback and rewards, supported by a companion mobile app, while a control group receives conventional care. Objective adherence data from the sensors and patient-reported measures such as the Intrinsic Motivation Inventory will be collected. Outcomes will compare brace-wearing time and psychosocial responses between the digital support system and conventional treatment.

Who should consider this trial

Good fit: Ideal candidates are 10–18-year-olds with a clinical diagnosis of adolescent idiopathic scoliosis who have an active prescription for a corrective spinal brace, can complete study questionnaires, have stable home Wi‑Fi, and whose guardians can provide consent.

Not a fit: Patients with secondary (neuromuscular, congenital, or syndromic) scoliosis, those scheduled for spinal surgery during the study period, those with severe skin allergies at brace contact sites, or those without home network access or willingness to use the devices are unlikely to benefit.

Why it matters

Potential benefit: If successful, the system could increase brace-wearing time, reduce emotional distress, and improve spinal outcomes for adolescents with AIS.

How similar studies have performed: Previous research using sensor-based monitoring and feedback has shown promising improvements in brace adherence, but the integrated narrative desktop terminal approach is novel and less tested.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Zhao Liu — Shanghai Jiao Tong University School of Medicine
• Study coordinator: Dian Zhu, Dr

Conditions: Adolescent Idiopathic Scoliosis, Adherence