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NOT YET RECRUITING
NCT07341633
NA

AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis

Sponsor: Jinan University Guangzhou

View on ClinicalTrials.gov

Summary

This randomized controlled trial (RCT) evaluates the efficacy of a novel Artificial Intelligence (AI)-based digital therapeutic system compared to traditional outpatient Schroth exercises for the treatment of Adolescent Idiopathic Scoliosis (AIS). The intervention utilizes a smartphone application with computer vision technology to perform remote, personalized posture analysis and generate adaptive exercise prescriptions. The study aims to determine if this "Human-in-the-Loop" AI model demonstrates superior clinical outcomes in controlling spinal curve progression and improving treatment adherence compared to standard conservative care over a 6-month period.

Official title: Efficacy of Artificial Intelligence-Based Digital Therapeutics Versus Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-02-01

Completion Date

2028-01-01

Last Updated

2026-01-14

Healthy Volunteers

No

Interventions

DEVICE

AI-Based Digital Therapeutic System

A smartphone-based digital therapeutic application that utilizes computer vision (MediaPipe Framework) to capture and analyze patient posture bi-weekly. The system employs a hierarchical triage logic to classify curve patterns and assign personalized Schroth-based exercise modules. It features a "Human-in-the-Loop" safety protocol where a Clinical Research Assistant validates the AI-generated prescription before release. The exercise dosing (intensity and props) is adaptively adjusted based on the calculated metric changes (NSI) every two weeks .

PROCEDURE

Standard Outpatient Schroth Therapy

Standard conservative management based on the SOSORT and Schroth Best Practice guidelines. Participants undergo an initial 60-minute comprehensive evaluation and education session. The intervention consists of a daily home exercise program (30 minutes/day) and mandatory monthly face-to-face supervised sessions at the outpatient clinic, where a certified therapist manually adjusts the exercise prescription based on clinical progression .

Locations (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China