ActiveNANCT07341633

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

ConditionAdolescent Idiopathic Scoliosis (AIS)
InterventionAI-Based Digital Therapeutic System; Standard Outpatient Schroth Therapy
PhaseNA
StatusActive
Participants300
Est. Completion1 Jan 2028
Last Updated23 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

China
View Registry Entry

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