- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482748
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Effect of Diaphragm Mobilization Added to the Schroth Best Practice Program in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity that can affect posture, trunk movement, and respiratory function. Changes in the shape of the rib cage may influence diaphragm function and breathing mechanics in individuals with scoliosis. The Schroth Best Practice (SBP) exercise program is commonly used in the conservative treatment of scoliosis and focuses on posture correction and scoliosis-specific exercises. However, the additional benefits of manual diaphragm mobilization combined with this exercise program are not well known.
The aim of this randomized controlled trial is to investigate the effect of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants will be randomly assigned to two groups: one group will perform the SBP exercise program alone, and the other group will receive SBP exercises combined with diaphragm mobilization. The intervention will be performed three times per week for six weeks.
Assessments will be conducted at baseline, at the end of the 6-week intervention, and at a 12-week follow-up. Outcomes will include respiratory function measured by spirometry, trunk rotation, thoracic mobility, trunk flexibility, quality of life, and body image. The results of this study may help determine whether adding diaphragm mobilization to scoliosis-specific exercise programs improves clinical outcomes in adolescents with idiopathic scoliosis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine that occurs during growth and may affect posture, trunk mechanics, and respiratory function. Thoracic deformity and rib cage asymmetry associated with scoliosis can alter the biomechanical function of the diaphragm and reduce respiratory efficiency. Previous studies have reported decreased pulmonary function parameters in individuals with AIS, which may contribute to functional limitations and reduced quality of life.
Physiotherapeutic scoliosis-specific exercise approaches, such as the Schroth Best Practice (SBP) program, are widely used in the conservative management of scoliosis. The SBP program includes curve-specific corrective exercises and postural education aimed at improving spinal alignment, trunk symmetry, and functional capacity. Despite the documented benefits of SBP exercises, the potential role of diaphragm-focused manual therapy techniques in scoliosis rehabilitation has not been sufficiently investigated.
This study is designed as a prospective, randomized, parallel-group clinical trial to evaluate the effectiveness of diaphragm mobilization added to the Schroth Best Practice program in adolescents with idiopathic scoliosis. Participants diagnosed with AIS will be randomly assigned to one of two groups: (1) SBP exercise program combined with diaphragm mobilization or (2) SBP exercise program alone. The intervention will be performed three times per week for six weeks.
Clinical assessments will be conducted at baseline, at the end of the 6-week intervention period, and at a 12-week follow-up. Primary outcomes will include respiratory function parameters measured using spirometry, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and peak expiratory flow (PEF). Secondary outcomes will include trunk rotation measured using a scoliometer, thoracic mobility assessed by thoracic circumference difference during maximal inspiration and expiration, trunk lateral flexion flexibility, and patient-reported outcomes including quality of life (Scoliosis Research Society-22 questionnaire) and body image (Walter Reed Visual Assessment Scale).
The findings of this study are expected to provide evidence regarding the clinical effects of diaphragm mobilization when integrated into scoliosis-specific exercise programs and may contribute to the development of more comprehensive rehabilitation strategies for adolescents with idiopathic scoliosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eray Yüceel, PT, MSc(c)
- Phone Number: +90(538)8861539
- Email: eryuceel@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents aged between 10 and 18 years
- Diagnosis of adolescent idiopathic scoliosis
- Cobb angle ≥ 10°
- Ability to participate in exercise sessions
- Written informed consent from the participant and their parent or legal guardian
Exclusion Criteria:
- Non-idiopathic scoliosis (e.g., neuromuscular, congenital, or syndromic scoliosis)
- Presence of congenital anomalies affecting the musculoskeletal system
- Previous scoliosis treatment within the last 6 months
- Participation in another physiotherapy or rehabilitation program during the study period
- Current use of a scoliosis brace
- History of spinal surgery
- Presence of neurological, rheumatological, or cardiopulmonary diseases that may affect participation in the intervention
- Cognitive impairment, communication disorders, or any condition that may limit the ability to follow instructions or complete assessments
Study Plan
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: Schroth Best Practice Program + Diaphragm Mobilization
Participants in this group will receive the Schroth Best Practice exercise program combined with diaphragm mobilization.
The intervention will be performed three times per week for six weeks.
|
Manual diaphragm mobilization will be performed with the participant in the supine position.
The therapist will place both hands along the inferior costal margin and apply a gentle mobilization in coordination with the participant's breathing cycle.
During inspiration and expiration, the inferior costal margin will be mobilized in a cranial and lateral direction.
The technique will be performed for 20 breathing cycles and repeated twice during each treatment session with short rest periods between repetitions.
The intervention will be applied at the end of each treatment session throughout the 6-week treatment period.
Other Names:
The Schroth Best Practice (SBP) program is a physiotherapeutic scoliosis-specific exercise approach that includes curve-specific corrective exercises and postural education.
Participants will perform exercises tailored to their scoliosis curve pattern under the supervision of a physiotherapist.
The program will be applied three times per week for six weeks.
Other Names:
|
|
Active Comparator: Schroth Best Practice Program
Participants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks.
|
The Schroth Best Practice (SBP) program is a physiotherapeutic scoliosis-specific exercise approach that includes curve-specific corrective exercises and postural education.
Participants will perform exercises tailored to their scoliosis curve pattern under the supervision of a physiotherapist.
The program will be applied three times per week for six weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Forced vital capacity (FVC), expressed in liters, will be measured by spirometry to assess pulmonary function.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Forced Expiratory Volume in One Second
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Forced expiratory volume in one second (FEV1), expressed in liters, will be measured by spirometry to assess pulmonary function.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
FEV1/FVC Ratio
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
The FEV1/FVC ratio, expressed as a percentage, will be calculated from spirometry measurements to assess pulmonary function.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Peak Expiratory Flow
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Peak expiratory flow (PEF), expressed in liters per minute, will be measured by spirometry to assess pulmonary function.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk rotation angle measured by scoliometer
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Angle of trunk rotation will be measured using a scoliometer during the forward Adam's bending test to assess spinal rotation.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Thoracic mobility measured by thoracic circumference difference
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Thoracic mobility will be assessed by measuring chest circumference at the xiphoid process level during maximal inspiration and maximal expiration using a measuring tape.
The difference between the two measurements will be recorded in centimeters.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Trunk lateral flexion flexibility
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Trunk lateral flexion flexibility will be assessed by measuring the distance between the fingertips and the floor during lateral bending.
Measurements will be performed bilaterally, and the distance between the fingertips and the floor will be recorded in centimeters.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Quality of life measured by Scoliosis Research Society-22 questionnaire
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
This questionnaire assesses multiple domains including function/activity, pain, self-image, mental health, and satisfaction with management.
The total score ranges from 22 to 110, higher scores indicate better health-related quality of life.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
|
Body image measured by Walter Reed Visual Assessment Scale
Time Frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Body image perception will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
The WRVAS evaluates the patient's perception of scoliosis-related trunk deformity using visual illustrations.
Total scores range from 7 to 35, with higher scores indicating greater perceived deformity and worse body image perception.
|
Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tuğba KURU ÇOLAK, PT, PhD, Marmara University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2025/303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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