Adolescent Idiopathic ScoliosisNCT07482748
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
A study testing Diaphragm Mobilization and Schroth Best Practice Exercise Program in people with Adolescent Idiopathic Scoliosis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Diaphragm Mobilization and Schroth Best Practice Exercise Program
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
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
Marmara Üniversitesi, Sağlık Bilimleri Fakültesi, Fizyoterapi ve Rehabilitasyon Bölümü
Istanbul
Eray Yüceel, 5388861539, eryuceel@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Diaphragm Mobilization, Schroth Best Practice Exercise Program
- Keywords
- Adolescent Idiopathic Scoliosis, Diaphragm Mobilization, Scoliosis-Specific Exercise, Respiratory Function, Physiotherapy
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm MobilizationProcedure or surgery
Also called Manual Diaphragm Release, Diaphragmatic Mobilization
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.
Schroth Best Practice Exercise ProgramBehavioural
Also called Schroth Exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| Schroth Best Practice Program + Diaphragm Mobilization | Experimental | 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. Receives: Procedure: Diaphragm Mobilization; Behavioral: Schroth Best Practice Exercise Program |
| Schroth Best Practice Program | Active comparator | Participants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks. Receives: Behavioral: Schroth Best Practice Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity
Forced vital capacity (FVC), expressed in liters, will be measured by spirometry to assess pulmonary function.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Forced Expiratory Volume in One Second
Forced expiratory volume in one second (FEV1), expressed in liters, will be measured by spirometry to assess pulmonary function.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
FEV1/FVC Ratio
The FEV1/FVC ratio, expressed as a percentage, will be calculated from spirometry measurements to assess pulmonary function.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Peak Expiratory Flow
Peak expiratory flow (PEF), expressed in liters per minute, will be measured by spirometry to assess pulmonary function.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Secondary outcomes (5)
Trunk rotation angle measured by scoliometer
Angle of trunk rotation will be measured using a scoliometer during the forward Adam's bending test to assess spinal rotation.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Thoracic mobility measured by thoracic circumference difference
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.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Trunk lateral flexion flexibility
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.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Quality of life measured by Scoliosis Research Society-22 questionnaire
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.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Body image measured by Walter Reed Visual Assessment Scale
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.
Measured: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start20 May 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated into two parallel groups: (1) Schroth Best Practice exercise program and (2) Schroth Best Practice exercise program combined with diaphragm mobilization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Kuru Çolak, Marmara University
- Investigators
- Tuğba KURU ÇOLAK, PT, PhD, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482748
- Sponsor's protocol ID
- 09.2025/303
- Status last verified
- May 2026
- First submitted
- 6 Mar 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diaphragm Mobilization Added to the Schroth Best Practice Program in Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07482748
- Acronym / sponsor ID
- 09.2025/303
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, Diaphragm Mobilization, Scoliosis-Specific Exercise, Respiratory Function, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated into two parallel groups: (1) Schroth Best Practice exercise program and (2) Schroth Best Practice exercise program combined with diaphragm mobilization.
| Arm | Type | Receives |
|---|---|---|
| Schroth Best Practice Program + Diaphragm Mobilization | Experimental | Procedure: Diaphragm Mobilization, Behavioral: Schroth Best Practice Exercise ProgramParticipants 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. |
| Schroth Best Practice Program | Active comparator | Behavioral: Schroth Best Practice Exercise ProgramParticipants in this group will receive the Schroth Best Practice exercise program three times per week for six weeks. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm MobilizationAlso: Manual Diaphragm Release, Diaphragmatic MobilizationManual 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. | Procedure or surgery | Schroth Best Practice Program + Diaphragm Mobilization |
| Schroth Best Practice Exercise ProgramAlso: Schroth ExercisesThe 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. | Behavioural | Schroth Best Practice Program, Schroth Best Practice Program + Diaphragm Mobilization |
Primary outcome
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.
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.
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.
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.
5 secondary outcomes
Trunk rotation angle measured by scoliometer
Time frame: 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)
Trunk lateral flexion flexibility
Time frame: 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)
Body image measured by Walter Reed Visual Assessment Scale
Time frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tuğba KURU ÇOLAK, PT, PhD principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm Mobilization and Schroth Best Practice Exercise Program in people with Adolescent Idiopathic Scoliosis, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eray Yüceel, PT, MSc(c) (+90(538)8861539, eryuceel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (time frame: Baseline, 6 weeks (post-intervention), and 12 weeks (follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.