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NCT Number: NCT07341633

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adolescent Idiopathic Scoliosis (AIS) Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Adolescent Idiopathic Scoliosis (AIS).
  • Age between 10 and 18 years (inclusive).
  • Cobb angle of the major curve between 10° and 30°.
  • Risser sign 0-2 (indicating skeletal immaturity).
  • Ability to operate a smartphone and follow instructions for the digital therapeutic application.
  • Patient and legal guardian provide written informed consent.

Exclusion criteria

  • Non-idiopathic scoliosis (e.g., congenital, neuromuscular, or syndromic etiology).
  • History of prior spinal surgery or currently scheduled for surgery.
  • Contraindications to exercise therapy (e.g., cardiac or respiratory insufficiency).
  • Severe cognitive or psychiatric disorders that prevent compliance with the protocol.
  • Currently receiving other scoliosis-specific treatments (e.g., bracing) outside of the study protocol (unless stratified).

Treatment and study plan

AI-Based Digital Therapeutic System

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 .

Standard Outpatient Schroth Therapy

Behavioral

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 .

Primary outcomes

  1. Absolute Change in Major Curve Cobb Angle

    Time frame: Baseline, 3 months, and 6 months

    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.

Secondary outcomes

  1. Treatment Adherence Rate

    Time frame: Baseline, 3 months, and 6 months

    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.

  2. Change in Angle of Trunk Rotation (ATR)

    Time frame: Baseline, 3 months, and 6 months

    Measured using a Scoliometer during the Adam's Forward Bend Test. The maximum rotation angle of the trunk is recorded in degrees.

  3. Change in Quality of Life (SRS-22r Score)

    Time frame: Baseline, 3 months, and 6 months

    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.

  4. Change in Trunk Appearance Perception (TAPS)

    Time frame: Baseline, 3 months, and 6 months

    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).

Sponsors and collaborators

Lead sponsor

Jinan University Guangzhou

Other

Collaborators

  • Guangzhou Women and Children's Medical Center

Registry information

Official study title

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

Acronym: AIS-DTx-RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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