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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adolescent Idiopathic Scoliosis (AIS)
• Intervention / Treatment: Device: AI-Based Digital Therapeutic System; Behavioral: Standard Outpatient Schroth Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women and Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 .	Behavioral: 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 .
Experimental: 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.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Major Curve Cobb Angle	Measured on standardized standing posteroanterior full-spine radiographs. The Cobb angle is the angle formed between the upper endplate of the most tilted upper vertebra and the lower endplate of the most tilted lower vertebra. Measurements are performed in degrees by independent radiologists who are blinded to group allocation. A negative value indicates a reduction (improvement) in the spinal curve.	Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Adherence Rate	Calculated as the percentage of completed exercise sessions relative to the prescribed sessions. For the Intervention group, adherence is logged automatically by the app via computer vision verification. For the Control group, adherence is self-reported via paper logs.	Baseline, 3 months, and 6 months
Change in Angle of Trunk Rotation (ATR)	Measured using a Scoliometer during the Adam's Forward Bend Test. The maximum rotation angle of the trunk is recorded in degrees.	Baseline, 3 months, and 6 months
Change in Quality of Life (SRS-22r Score)	Assessed using the Scoliosis Research Society-22 revised (SRS-22r) questionnaire. The score ranges from 1 to 5, with higher scores indicating better patient outcomes across domains of function, pain, self-image, and mental health.	Baseline, 3 months, and 6 months
Change in Trunk Appearance Perception (TAPS)	Assessed using the Trunk Appearance Perception Scale (TAPS), a patient-reported outcome measure of self-perceived trunk deformity. Scores range from 1 (worst) to 5 (best).	Baseline, 3 months, and 6 months

Collaborators and Investigators

• Sponsor: Jinan University Guangzhou
• Collaborators: Guangzhou Women and Children's Medical Center
• Investigators: Principal Investigator: Lili Shu, MD, Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Scoliosis; Artificial Intelligence; Digital Therapeutics; Tele-rehabilitation; Schroth Method; Computer Vision
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: GWCMC-2025-497A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published results, including baseline demographics, Risser sign, Cobb angle, Angle of Trunk Rotation, TAPS scores, SRS-22r scores, and adherence metrics for all randomised participants, will be made available. All data will be anonymised prior to sharing; no facial images or directly identifying information will be released.
• IPD Sharing Time Frame: Beginning 9 months after publication of the primary results article and ending 36 months thereafter.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers whose proposed use has been approved by an independent review committee for the purpose of individual participant data meta-analyses or methodologically sound secondary analyses. Requests should be directed to the corresponding author (penny@link.cuhk.edu.hk) and must include a detailed research proposal, a statistical analysis plan, and evidence of ethical approval from the requester's institution. Data will be shared through a secure data transfer platform following the execution of a signed Data Use Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No