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RecruitingNCT07556042Updated Aug 19, 2026

Machine Learning Prediction of Disease Progression in Adolescent Idiopathic Scoliosis

An interventional study of Core Stabilization Exercise in Adolescence Idiopathic Scoliosis, sponsored by Istanbul University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Adolescence Idiopathic Scoliosis

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Keywords

  • scoliosis
  • exercise therapy
  • machine learning
  • Artificial Intelligence
03

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralCore 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.

05

What researchers measure

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.

    Time frame: 12 weeks

Secondary outcomes

  1. Demographic Parameters

    Age, Sex, BMI, Type of Scoliosis

    Time frame: 12 weeks

  2. Risser Score

    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.

    Time frame: 12 weeks

  3. Angle of Trunk Rotation

    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.

    Time frame: 12 weeks

  4. The Walter Reed Visual Assessment Scale

    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.

    Time frame: 12 weeks

  5. Biodex postural stability and limits of stability

    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.

    Time frame: 12 weeks

  6. Respiratory Pressure

    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.

    Time frame: 12 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07556042
Lead sponsor
Istanbul University
Collaborators
Bezmialem Vakif University, Uskudar University
Responsible party
Fuat Gokdemir (Research Assistant, Bezmialem Vakif University) — Principal investigator
First posted
Apr 29, 2026
Start date
Apr 20, 2026
Primary completion
Sep 10, 2026 (estimated)
Completion
Sep 12, 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

Fuat Gökdemir
Contact
fuatgokdemir95@gmail.com
+90 212 401 26 00
Ayse Manzak Dursun
Contact
amanzak@bezmialem.edu.tr
+90 212 401 26 00
Fuat Gökdemir
principal investigator · Bezmialem Vakif University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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