Machine Learning Prediction of Disease Progression in Adolescent Idiopathic Scoliosis

NCT07556042 | Recruiting

• 1 other identifier: IUFGokdemir03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adolescence Idiopathic Scoliosis

Keywords

scoliosis; exercise therapy; machine learning; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Cobb Angle

  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 Outcomes (6)

• Demographic Parameters

  12 weeks

• Risser Score

  12 weeks

• Angle of Trunk Rotation

  12 weeks

• The Walter Reed Visual Assessment Scale

  12 weeks

• Biodex postural stability and limits of stability

  12 weeks

Study Arms (1)

Core Stabilization Exercise Group

EXPERIMENTAL

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

Interventions

Core Stabilization Exercise BEHAVIORAL

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.

Core Stabilization Exercise Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Bezmialem Vakif University: collaborator
• Uskudar University: collaborator

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyupsultan, 34060, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Fuat Gökdemir

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuat Gökdemir

CONTACT

+90 212 401 26 00; fuatgokdemir95@gmail.com

Ayse Manzak Dursun

CONTACT

+90 212 401 26 00; amanzak@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study follows a hybrid design consisting of retrospective model development and prospective external validation. A machine learning model will first be developed using historical clinical data from adolescents with idiopathic scoliosis who underwent core stabilization exercise. The model will then be validated prospectively using newly collected post-intervention data from a similar patient population. All participants receive the same core stabilization exercise program as part of standard physiotherapy care. The primary objective is prediction of post-intervention Cobb angle rather than comparison between treatment arms.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 12, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)