Machine Learning Prediction of Disease Progression in Adolescent Idiopathic Scoliosis

April 22, 2026 updated by: Fuat Gokdemir, Istanbul University

Machine Learning-Based Prediction of Disease Progression in Adolescent Idiopathic Scoliosis Following Core Stabilization Exercise: A Retrospective Model Development and Prospective Validation Study

Background and Problem Overview Adolescent Idiopathic Scoliosis (AIS) is a progressive musculoskeletal disorder characterized by a three-dimensional deformation of the spine occurring during adolescence. Diagnosis is typically established with a Cobb angle exceeding 10° and the presence of axial rotation. While the exact etiology remains unknown, leading theories include tissue abnormalities (muscle fibers, bone volume), impaired spinal biomechanics (asymmetric bone growth), and neurological factors (asymmetric cortical thickness, cerebral lateralization, and body schema distortions).

The progressive nature of AIS, particularly the high risk of advancement at the onset of puberty, complicates clinical decision-making. Treatment is traditionally divided into three stages:

Observation and Exercise: For Cobb angles between 10°-25°.

Exercise and Bracing: For Cobb angles between 25°-45°.

Surgery: For Cobb angles exceeding 45°.

Despite these guidelines, the unpredictable progression of the disease and difficulties in treatment adherence create significant dilemmas. Specifically, for cases on the borderline of surgical indication, clinicians face the challenge of choosing between immediate surgery or conservative monitoring. Currently, there is no definitive method to predict progression, and patients are typically monitored in 6-month intervals. During these intervals, a patient's condition may remain stable or deteriorate significantly.

Furthermore, guidelines recommend wearing a brace for an average of 18 hours per day, often for several years. This requirement is physically and psychologically demanding for adolescents, leading to poor compliance due to aesthetic concerns, functional limitations, and skin irritation. The inability to predict progression often leads to overtreatment (unnecessary bracing) or undertreatment (delayed intervention), both of which pose risks to the patient's long-term health.

Radiological Concerns Disease progression is monitored via direct radiography (X-rays). However, frequent imaging increases the lifetime risk of cancer due to cumulative ionizing radiation. Notably, the risk of breast cancer in girls with AIS is reported to be approximately seven times higher than in the healthy population. Conversely, extending follow-up intervals risks missing windows for early intervention. An artificial intelligence (AI) model capable of predicting curve progression could optimize imaging frequency, ensuring safety while maintaining clinical efficacy.

Objective and Methodology of the Study

The primary aim of this research is to develop a machine learning-based model to predict the Cobb angle following a 12-week exercise intervention. The model will utilize comprehensive baseline and post-treatment data, including:

Demographic and Anthropometric Data (Age, height, weight, gender).

Clinical Assessments (Cobb angle, Risser score, angle of trunk rotation).

Functional and Physical Metrics (Trunk muscle strength, Maximal Inspiratory and Expiratory Pressure [MIP/MEP], Biodex balance measurements).

Visual Assessments (Walter Reed Visual Deformity Scale [WRVAS]).

Research Hypotheses

Primary Hypothesis: A machine learning model trained on pre- and post-exercise assessment data can significantly predict the Cobb angle at the end of a 12-week period with both statistical and clinical accuracy.

Secondary Hypothesis: By predicting the risk of progression (the probability of an increase in Cobb angle), this model will contribute to reducing unnecessary surgical interventions, overtreatment (bracing/surgery), and cumulative X-ray exposure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • being between the ages of 10 and 18
  • having a Cobb angle between 10 and 40 degrees
  • not receiving any other exercise treatment (scoliosis-specific exercises, etc.) from a different center that would affect the patient's scoliosis

Exclusion Criteria:

  • history of scoliosis surgery
  • patients who had undergone any type of surgical procedure within the last 3 months were excluded
  • orthopedic, neurological, or systemic diseases that would hinder exercise
  • Intellectual, behavioral, or communication disorders affecting understanding of instructions or exercise performance, or participation in any exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core Stabilization Exercise Group

Participants in this arm are adolescents with idiopathic scoliosis who receive a standardized core stabilization exercise program as part of routine physiotherapy care. The intervention is applied for 12 weeks.

All participants undergo clinical and functional assessments before and after the intervention, including radiographic evaluation of Cobb angle and other scoliosis-related parameters such as trunk rotation, muscle strength, balance, and respiratory muscle function.

The purpose of this arm is not to compare different treatments, but to generate and validate a machine learning model for predicting post-intervention disease progression based on pre- and post-treatment clinical data.
Behavioral: Core Stabilization Exercise

weeks. The exercise program focuses on improving trunk muscle control, postural stability, and spinal alignment.

The intervention is delivered as part of routine physiotherapy care. Participants perform exercises targeting deep trunk stabilizers, including abdominal, paraspinal, and pelvic musculature. Exercise progression is based on patient tolerance and clinical evaluation.

Clinical and radiological assessments are performed before and after the intervention, including Cobb angle measurement and functional evaluations such as muscle strength, balance, respiratory muscle strength, and trunk rotation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cobb Angle
Time Frame: 12 weeks

The primary outcome is the Cobb angle measured 12 weeks after core stabilization exercise intervention in adolescents with idiopathic scoliosis. The Cobb angle is obtained from standard standing anteroposterior or posteroanterior spinal radiographs and represents the degree of spinal curvature.

This outcome is used as the target variable for the machine learning model to predict post-intervention disease progression.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Parameters
Time Frame: 12 weeks
Age, Sex, BMI, Type of Scoliosis
12 weeks
Risser Score
Time Frame: 12 weeks
Risser score is a radiographic measure used to assess skeletal maturity by evaluating the degree of ossification of the iliac apophysis on pelvic X-rays.
12 weeks
Angle of Trunk Rotation
Time Frame: 12 weeks
Angle of trunk rotation is a clinical measurement used to assess axial spinal deformity in scoliosis by quantifying trunk asymmetry during the forward bending test using a scoliometer.
12 weeks
The Walter Reed Visual Assessment Scale
Time Frame: 12 weeks
The Walter Reed Visual Assessment Scale is a patient-reported outcome measure used to evaluate perceived cosmetic deformity in scoliosis through standardized visual representations of body asymmetry.
12 weeks
Biodex postural stability and limits of stability
Time Frame: 12 weeks
Biodex postural stability and limits of stability are objective balance assessments that evaluate a person's ability to maintain and control their center of pressure during static and dynamic conditions using a computerized balance platform.
12 weeks
Respiratory Pressure
Time Frame: 12 weeks
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) are measures obtained using a mouth pressure device that assess respiratory muscle strength by recording the maximal pressures generated during forced inhalation and exhalation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Bezmialem Vakif University
Uskudar University

Investigators

  • Principal Investigator: Fuat Gökdemir, Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

September 12, 2026

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUFGokdemir03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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