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Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for AIS
Sponsor: Hangzhou Medical College
Summary
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.
Official title: Protocol for a Randomized Controlled Trial of a Clinician-Supervised Home-School-Hospital-Linked Digital Health Platform-Supported Conservative Management Pathway for Adolescent Idiopathic Scoliosis
Key Details
Gender
All
Age Range
12 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-03-26
Completion Date
2026-12-31
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Routine Guideline-Based Conservative Care
Routine conservative management according to the 2016 SOSORT guidelines, comprising observation, physiotherapeutic scoliosis-specific exercises, specialized inpatient rehabilitation, and bracing as clinically indicated. Delivered through routine outpatient consultations; participants have no access to the digital health management platform.
Clinician-Supervised, Platform-Assisted Conservative Management
Individualized conservative management supported by the comprehensive digital health management platform. The platform generates decision-support recommendations for observation, PSSE, specialized inpatient rehabilitation, or bracing, which must be reviewed, modified as needed, and formally approved by licensed clinicians before implementation. Platform functions include treatment reminders, standardized health education, follow-up scheduling, and home-school-hospital communication. The platform serves solely as a clinical decision-support tool and cannot generate automatic prescriptions or override clinical judgement.
Locations (1)
the Affiliated Zhejiang Provincial People's Hospital to Hangzhou Medical College
Hangzhou, Zhejiang, China