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

NCT ID: NCT07341633

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-01-01

Brief 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.

Detailed 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Outpatient Schroth Therapy

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 .

Group Type: ACTIVE_COMPARATOR

Standard Outpatient Schroth Therapy

Intervention Type: PROCEDURE

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 .

AI-Based Digital Therapeutics (AI-DTx)

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.

Group Type: EXPERIMENTAL

AI-Based Digital Therapeutic System

Intervention Type: DEVICE

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 .

Interventions

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 .

Intervention Type: DEVICE

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 .

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: collaborator

Jinan University Guangzhou

OTHER

Sponsor Role: lead

Responsible Party

Ma Ruisi

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lili Shu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Women and Children's Medical Center

Locations

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Rui Si Ma, PhD

Role: CONTACT

penny@link.cuhk.edu.hk

+85246216560

Facility Contacts

Rui Si Ma, PhD

Role: primary

penny@link.cuhk.edu.hk

46216560

Other Identifiers

GWCMC-2025-497A01

Identifier Type: -

Identifier Source: org_study_id