- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07779070
Supervised vs. Home Schroth Exercise in AIS
August 20, 2026 updated by: Mesut Arslan, Bitlis Eren University
Comparative Effectiveness of Supervised vs. Home-Based Schroth Exercises in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
This study aims to compare the effectiveness of supervised Schroth exercises versus a home-based exercise program in adolescents with Adolescent Idiopathic Scoliosis (AIS).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional spinal deformity that develops in children aged 10-18, affecting approximately 0.47% to 12% of this population.
If left untreated, curves between 10° and 45° may progress, leading to pain, breathing difficulties, postural problems, and reduced quality of life.
Although bracing and surgery are traditional options, they have limitations.
Physiotherapeutic scoliosis-specific exercises (PSSE), particularly the Schroth method, are increasingly recommended as a first-line conservative treatment.
Study Type
Interventional
Enrollment (Estimated)
62
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
- Name: Mesut Arslan, PhD
- Phone Number: +90 553 674 5226
- Email: fzt.mesutarslan@gmail.com
Study Locations
-
-
Istanbul
-
Siliviri, Istanbul, Turkey (Türkiye), 34570
- Silivri Devlet Hastanesi, Fizik Tedavi Ünitesi
-
Contact:
- Mehmet Emin Durbulu
- Phone Number: +90 506 146 4064
- Email: fztmehmetdurbulu@gmail.com
-
-
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:
- Diagnosis of Adolescent Idiopathic Scoliosis (idiopathic etiology)
- Age between 10 and 18 years
- Cobb angle between 10° and 45°
- Able to participate in a 5-day/week exercise program (supervised or home-based)
- Patient and parent/guardian provide written informed consent
- Sufficient cooperation to comply with the study protocol and complete assessments
Exclusion Criteria:
- Non-idiopathic scoliosis (neuromuscular, congenital, functional, etc.)
- Prior or planned spinal surgery
- Neurological, rheumatological, metabolic, or cardiopulmonary disease that would interfere with participation
- Brace treatment within the last 6 months or planned during the study
- Regular scoliosis-specific exercise (more than 2 days/week) within the last 6 months
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supervised Schroth Exercise Group (SSEG)
Participants in this group will receive the exercise program under direct, one-on-one supervision by a physiotherapist.
This is a purely physical exercise intervention.
No drugs or devices are used as part of the intervention.
Only the Schroth exercise program is administered.
|
60-minute Schroth exercise sessions, 5 days/week for 12 weeks, delivered under one-on-one physiotherapist supervision.
Includes 3D auto-correction, rotational breathing, postural stabilization, and curve-specific exercises (shoulder counter-pull, muscle cylinder, side-lying, sailing, prominent hip, Schroth walking)
|
|
Active Comparator: Home Exercise Program Group (HEPG)
Participants in this group will be provided with an individualized home exercise program that matches the supervised group in terms of principles, content, and duration.
This is a purely physical exercise intervention.
No drugs or devices are used as part of the intervention.
Only the Schroth exercise program is administered.
|
Same 60-minute Schroth exercise program, 5 days/week for 12 weeks, performed at home without direct physiotherapist supervision.
Participants receive initial instruction and an individualized exercise booklet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cobb Angle
Time Frame: Baseline and 3 months post-intervention
|
Change in the primary curve Cobb angle measured on standing posteroanterior full-spine radiographs, assessed at baseline and 3 months post-intervention.
|
Baseline and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Trunk Rotation Angle (ATR)
Time Frame: Baseline and 12 weeks
|
Change in angle of trunk rotation measured using a scoliometer during the Adam's Forward Bend Test.
|
Baseline and 12 weeks
|
|
Change in Thoracic Kyphosis
Time Frame: Baseline and 12 weeks
|
Change in thoracic kyphosis angle measured using an inclinometer at T1-T2 and T12-L1 levels.
|
Baseline and 12 weeks
|
|
Change in Lumbar Lordosis
Time Frame: Baseline and 12 weeks
|
Change in lumbar lordosis angle measured using an inclinometer at T12-L1 and S2-S3 levels.
|
Baseline and 12 weeks
|
|
Respiratory Function assessed by Spirometry (FVC, FEV1, FEV1/FVC, PEF, FEF25-75%)
Time Frame: Baseline and 12 weeks
|
Respiratory function will be assessed using a spirometry device.
The following parameters will be recorded and analyzed: Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), the FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Forced Expiratory Flow at 25-75% of FVC (FEF25-75%).
|
Baseline and 12 weeks
|
|
Change in Pain Level
Time Frame: Baseline and 12 weeks
|
Change in musculoskeletal pain/discomfort assessed using the Turkish-validated Cornell Musculoskeletal Discomfort Questionnaire (T-CMDQ) [19].
The questionnaire evaluates discomfort in 18 body regions over the past week across three dimensions: frequency, severity, and functional impact on daily activities.
A risk score is calculated for each body region by multiplying these three parameters.
For bilaterally assessed regions, the higher of the two side-specific scores is used in the analysis.
Higher scores indicate worse outcomes.
|
Baseline and 12 weeks
|
|
Change in Quality of Life
Time Frame: Baseline and 12 weeks
|
Change in health-related quality of life assessed using the Turkish-validated Scoliosis Research Society-22 (SRS-22) questionnaire.
The questionnaire consists of five domains: function, pain, self-image, mental health, and treatment satisfaction.
Each item is scored from 1 (worst) to 5 (best); domain and total scores range from 1 to 5. Higher scores indicate better outcomes.
The treatment satisfaction domain will be assessed only at 12 weeks; other domains assessed at both baseline and 12 weeks.
|
Baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
August 31, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Study Registration Dates
First Submitted
August 15, 2026
First Submitted That Met QC Criteria
August 20, 2026
First Posted (Actual)
August 21, 2026
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- E.9290
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.