AIS-DTx-RCTAI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis
This study aims to compare the effectiveness of AI-Based Digital Therapeutics versus traditional Schroth exercises in treating Adolescent Idiopathic Scoliosis.
AI-Based Digital Therapeutic System
+ Standard Outpatient Schroth Therapy
Bone Diseases+2
+ Musculoskeletal Diseases
+ Scoliosis
Treatment Study
Summary
Study start date: February 1, 2026
Actual date on which the first participant was enrolled.This study focuses on Adolescent Idiopathic Scoliosis (AIS), a condition that needs long-term management to prevent it from getting worse. While special exercises like the Schroth method are commonly used, they often face challenges such as accessibility issues and low adherence. The study aims to compare the effectiveness of a new AI-based digital therapy with traditional Schroth exercises. The study involves 300 adolescents aged 10-18, with a specific range of curve severity. The goal is to see if the AI-based therapy can improve treatment outcomes and adherence. Participants are divided into two groups. The Intervention Group uses a smartphone app that captures photos every two weeks. An AI algorithm analyzes these photos to assign personalized exercise modules, adjusting the intensity based on progress. A clinical assistant checks these prescriptions for safety before they're released. The Control Group receives standard Schroth therapy, which includes daily home exercises and monthly clinic visits. The study's primary goal is to measure changes in the major curve from the start to six months. Other outcomes include changes in trunk rotation, trunk appearance perception, quality of life, and adherence rates.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 10 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Guangzhou Women and Children's Medical Center
Guangzhou, ChinaOpen Guangzhou Women and Children's Medical Center in Google Maps