Adolescence Idiopathic Scoliosis
Conditions
Keywords
scoliosis, exercise therapy, machine learning, Artificial Intelligence
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.
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.
Sponsors
Istanbul University
Bezmialem Vakif University
Uskudar University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cobb Angle | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic Parameters | 12 weeks | Age, Sex, BMI, Type of Scoliosis |
| Risser Score | 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. |
| Angle of Trunk Rotation | 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. |
| The Walter Reed Visual Assessment Scale | 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. |
| Biodex postural stability and limits of stability | 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. |
| Respiratory Pressure | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFuat Gökdemir
CONTACTAyse Manzak Dursun
PRINCIPAL_INVESTIGATORFuat Gökdemir
Bezmialem Vakif University
Outcome results
None listed