Efficacy of Artificial Intelligence-Based Digital Therapeutics Versus Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
Sponsor: Jinan University Guangzhou
Trial Details
| Condition | Adolescent Idiopathic Scoliosis (AIS) |
| Intervention | AI-Based Digital Therapeutic System; Standard Outpatient Schroth Therapy |
| Phase | NA |
| Status | Active |
| Participants | 300 |
| Est. Completion | 1 Jan 2028 |
| Last Updated | 23 Apr 2026 |
Primary Outcome
Absolute Change in Major Curve Cobb Angle
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Diagnosis of Adolescent Idiopathic Scoliosis (AIS). 2. Age between 10 and 18 years (inclusive). 3. Cobb angle of the major curve between 10° and 30°. 4. Risser sign 0-2 (indicating skeletal immaturity). 5. Ability to operate a smartphone and follow instructions for the digital therapeutic application. 6. Patient and legal guardian provide written informed consent. Exclusion Criteria: 1. Non-idiopathic scoliosis (e.g., congenital, neuromuscular, or syndromic etiology). 2. History of prior spinal surgery or currently scheduled for surgery. 3. Contraindications to exercise therapy (e.g., cardiac or respiratory insufficiency). 4. Severe cognitive or psychiatric disorders that prevent compliance with the protocol. 5. Currently receiving other scoliosis-specific treatments (e.g., bracing) outside of the study protocol (unless stratified).
Trial Sites
Countries
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