AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis (AIS-DTx-RCT)

Jinan University Guangzhou

Status: Not yet enrolling

Conditions: Adolescent Idiopathic Scoliosis (AIS)

Treatments: Procedure: Standard Outpatient Schroth Therapy; Device: AI-Based Digital Therapeutic System

Study type: Interventional

Funder types: Other

Identifiers

NCT07341633

GWCMC-2025-497A01

Details and patient eligibility

About

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.

Full description

Background: Adolescent Idiopathic Scoliosis (AIS) requires long-term conservative management to prevent curve progression. While Physiotherapeutic Scoliosis Specific Exercises (PSSE), such as the Schroth method, are the gold standard, their efficacy is often limited by accessibility barriers and suboptimal adherence.

Study Design: This is a parallel-group, single-blind randomized controlled trial. A total of 300 eligible adolescents (aged 10-18, Cobb angle 10-30°, Risser sign 0-2) will be randomized in a 1:1 ratio into an Intervention Group or a Control Group.

Interventions:

Intervention Group (AI-DTx): Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (based on MediaPipe) extracts skeletal landmarks to classify curve patterns and assign personalized exercise modules. The system features a "Check-and-Adjust" matrix to adapt exercise intensity based on metric changes. A Clinical Research Assistant (Human-in-the-Loop) verifies all prescriptions for safety before release.

Control Group (Standard Care): Participants receive standard outpatient Schroth therapy, involving daily home exercises and monthly supervised clinic visits, following SOSORT guidelines.

Objectives: The primary objective is to evaluate the absolute change in the major curve Cobb angle from baseline to six months. Secondary outcomes include the Angle of Trunk Rotation (ATR), trunk appearance perception (TAPS), quality of life (SRS-22r), and adherence rates. The study hypothesizes that the AI-driven intervention will demonstrate superior efficacy and adherence compared to traditional outpatient care.

Enrollment: 300 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Standard Outpatient Schroth Therapy

Active Comparator group

Description:

Participants receive standard conservative care based on Schroth Best Practice guidelines. This involves an initial 60-minute comprehensive evaluation, followed by a personalized home exercise program (30 minutes daily). Participants attend monthly supervised sessions at the outpatient clinic for manual prescription adjustments by a certified therapist .

Treatment:

Procedure: Standard Outpatient Schroth Therapy

AI-Based Digital Therapeutics (AI-DTx)

Experimental group

Description:

Participants utilize a smartphone application to capture standardized photos every two weeks. An AI algorithm (MediaPipe-based) processes these images to classify curve patterns and assign personalized exercise modules. The system uses a "Human-in-the-Loop" workflow where a Clinical Research Assistant verifies the AI-generated prescription before release. Dosing intensity is adaptively adjusted based on metric changes.

Treatment:

Device: AI-Based Digital Therapeutic System