Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS

Adolescent idiopathic scoliosis (AIS) brings substantial physical and psychological burden to affected teenagers, and current conservative follow-up management is fragmented under routine clinical settings. This single-center, superiority, parallel-group, 1:1 randomized controlled trial with assessor-blinded outcome evaluation will compare a clinician-supervised, platform-supported collaborative care pathway with routine guideline-based conservative care in 76 adolescents with mild-to-moderate AIS. Participants will be assessed at baseline, 4-month (primary endpoint), 8-month, and 12-month follow-up. The primary outcome is the change in Cobb angle from baseline to 4 months. Secondary outcomes include treatment adherence, mental-health status, medical expenditure, participant and guardian satisfaction, and safety outcomes. The primary analysis will follow the intention-to-treat principle. The first participant was enrolled on 26 March 2025; to date, 35 of the target 76 participants have been recruited.

Inclusion Criteria: 1. Confirmed diagnosis of mild-to-moderate Adolescent Idiopathic Scoliosis (AIS), with a Cobb angle of 10 degrees or greater and less than 45 degrees. 2. Age 12 to 16 years, targeting adolescents in the active pubertal growth phase, in whom conservative management (PSSE and bracing) is clinically prioritized. 3. Sufficient cognitive and communicative ability to understand the study procedures and use the platform. 4. Voluntary participation confirmed by signed guardian informed consent and adolescent participant assent. 5. Participants with prior conservative treatment (PSSE or bracing) are eligible provided the treatment regimen has been stable for at least 3 months prior to baseline assessment. Exclusion Criteria: 1. Secondary scoliosis caused by identifiable causes such as spinal trauma or prior spinal surgery. 2. Clinically significant severe functional impairment of heart, liver, or kidney organ function, defined as grade 3 or higher organ dysfunction according to CTCAE version 5.0. 3. Malignant tumours, autoimmune diseases, or other critical systemic illnesses that may interfere with trial outcomes. 4. Severe cognitive or psychiatric conditions, including diagnosed intellectual disability, psychotic disorders, or major depressive disorder under active psychiatric intervention, that prevent obtaining valid assent or completing study assessments.