- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552662
Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises With Idiopathic Scoliosis
April 20, 2026 updated by: Yavuz Yakut, Hasan Kalyoncu University
Comparative Effectiveness of Physiotherapeutic Scoliosis-Specific Exercises Versus General Exercises in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
This randomized controlled trial evaluates the effectiveness of Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) compared with General Exercises in adolescents with idiopathic scoliosis over a 12-month intervention period.
Primary outcomes include Cobb angle progression and brace prescription rate.
Secondary outcomes include trunk rotation, quality of life, self-image, and body symmetry.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Adolescent idiopathic scoliosis is a three-dimensional spinal deformity that may progress during growth.
Although PSSE is increasingly recommended in conservative scoliosis management, comparative randomized evidence remains limited.
This study aims to compare PSSE-Schroth exercises with General Exercises in adolescents with mild idiopathic scoliosis over 12 months.
Participants are randomized into intervention or control groups receiving matched exercise dosage and supervision.
Outcomes assess radiographic progression, trunk rotation, need for bracing, and patient-reported clinical parameters.
Study Type
Interventional
Enrollment (Actual)
32
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 Locations
-
-
Şahinbey
-
Gaziantep, Şahinbey, Turkey (Türkiye), 27000
- Hasan Kalyoncu University
-
-
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
Yes
Description
Inclusion Criteria:
Diagnosis of adolescent idiopathic scoliosis
- Cobb angle 10°-25°
- Risser sign 0-3 ATR >5°
- Less than 1 year post-menarche (for females)
Exclusion Criteria:
Previous brace treatment * Non-idiopathic scoliosis
- Previous scoliosis surgery
- Neuromuscular or congenital scoliosis
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: PSSE-Schroth Group
Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training.
|
Participants performed individualized PSSE-Schroth exercises based on curve pattern, including corrective breathing, postural correction, and ADL training
|
|
Active Comparator: General Exercise Group
Participants performed general strengthening and stretching exercises without scoliosis-specific correction.
|
Participants performed general strengthening and stretching exercises without scoliosis-specific correction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cobb Angle
Time Frame: Baseline to 12 Months
|
Cobb angle will be measured on standing anteroposterior spinal radiographs using the standard Cobb method.
The angle is defined as the intersection of lines drawn parallel to the superior endplate of the upper-end vertebra and the inferior endplate of the lower-end vertebra of the primary curve.
Measurements will be performed at baseline and after the intervention period, and the change in Cobb angle (in degrees) will be calculated.
Lower values indicate an improvement in spinal curvature.
|
Baseline to 12 Months
|
|
Brace Prescription Rate
Time Frame: 12 Months
|
The proportion of participants requiring orthotic bracing during the study period will be recorded.
Brace prescription will be determined by a specialist according to established clinical criteria (e.g., curve magnitude, skeletal maturity, and risk of progression).
The rate will be expressed as the percentage of participants prescribed a brace in each group during the follow-up period.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SRS-22 Questionnaire Score
Time Frame: Baseline to 12 Months
|
Health-related quality of life will be assessed using the Scoliosis Research Society-22 Questionnaire (SRS-22).
This validated instrument includes five domains: function/activity, pain, self-image/appearance, mental health, and satisfaction with management.
Each item is scored on a 5-point Likert scale, with higher scores indicating better health status.
Assessments will be performed at baseline and after the intervention period, and changes in domain and total scores will be analyzed.
|
Baseline to 12 Months
|
|
TAPS Score
Time Frame: Baseline to 12 Months
|
Trunk appearance will be assessed using the Trunk Appearance Perception Scale (TAPS).
This patient-reported outcome measure evaluates subjective perception of trunk deformity using a set of standardized drawings viewed from different perspectives.
Each item is scored on a Likert scale, with higher scores indicating better perceived trunk appearance (less deformity).
Assessments will be conducted at baseline and after the intervention period, and changes in TAPS scores will be analyzed.
|
Baseline to 12 Months
|
|
TRACE Score
Time Frame: Baseline to 12 Months
|
Clinical trunk deformity will be assessed using the Trunk Aesthetic Clinical Evaluation (TRACE) scale.
This clinician-rated tool evaluates visible asymmetries of the shoulders, scapulae, waist, and hemithorax.
Each domain is scored based on the severity of asymmetry, and a total score is calculated, with higher scores indicating greater aesthetic deformity.
Assessments will be performed at baseline and after the intervention period, and changes in TRACE scores will be analyzed.
|
Baseline to 12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.
- Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.
- Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. doi: 10.1056/NEJMoa1307337. Epub 2013 Sep 19.
- Asher M, Min Lai S, Burton D, Manna B. The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis. Spine (Phila Pa 1976). 2003 Jan 1;28(1):63-9. doi: 10.1097/00007632-200301010-00015.
- Zhang Y, Chai T, Weng H, Liu Y. Pelvic rotation correction combined with Schroth exercises for pelvic and spinal deformities in mild adolescent idiopathic scoliosis: A randomized controlled trial. PLoS One. 2024 Jul 30;19(7):e0307955. doi: 10.1371/journal.pone.0307955. eCollection 2024.
- Mohamed N, Acharya V, Schreiber S, Parent EC, Westover L. Effect of adding Schroth physiotherapeutic scoliosis specific exercises to standard care in adolescents with idiopathic scoliosis on posture assessed using surface topography: A secondary analysis of a Randomized Controlled Trial (RCT). PLoS One. 2024 Apr 30;19(4):e0302577. doi: 10.1371/journal.pone.0302577. eCollection 2024.
- Bago J, Sanchez-Raya J, Perez-Grueso FJ, Climent JM. The Trunk Appearance Perception Scale (TAPS): a new tool to evaluate subjective impression of trunk deformity in patients with idiopathic scoliosis. Scoliosis. 2010 Mar 25;5:6. doi: 10.1186/1748-7161-5-6.
- Langensiepen S, Semler O, Sobottke R, Fricke O, Franklin J, Schonau E, Eysel P. Measuring procedures to determine the Cobb angle in idiopathic scoliosis: a systematic review. Eur Spine J. 2013 Nov;22(11):2360-71. doi: 10.1007/s00586-013-2693-9. Epub 2013 Feb 27.
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 (Actual)
April 18, 2024
Primary Completion (Actual)
November 18, 2024
Study Completion (Actual)
November 18, 2025
Study Registration Dates
First Submitted
April 20, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 20, 2026
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 825/2
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
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