Adolescence Idiopathic ScoliosisNCT07556042
Machine Learning Prediction of Disease Progression in Adolescent Idiopathic Scoliosis
A study testing Core Stabilization Exercise in people with Adolescence Idiopathic Scoliosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescence Idiopathic Scoliosis
- What is being tested?
- Core Stabilization Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 12 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul
Fuat Gökdemir, fuatgokdemir95@gmail.com
Ayse Sena Manzak Dursun, amanzak@bezmialem.edu.tr
About this study
Official title: 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:
Read more
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
- Being tested
- Core Stabilization Exercise
- Keywords
- scoliosis, exercise therapy, machine learning, Artificial Intelligence
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Core Stabilization Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
Demographic Parameters
Age, Sex, BMI, Type of Scoliosis
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Apr 2026
- Primary completion10 Sep 2026 (estimated)
- Study completion12 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescence Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University, Uskudar University
- Responsible party
- Principal investigator, Fuat Gokdemir, Bezmialem Vakif University
- Investigators
- Fuat Gökdemir, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556042
- Sponsor's protocol ID
- IUFGokdemir03
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No