Spine DeformityNCT06417944
The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
An observational study of Spine Deformity and Scoliosis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Deformity, Scoliosis, Scoliosis Idiopathic
- What is being tested?
- Scoliosis study form, Scoliosis X-ray (orthorontgenogram) and Pulmonary function test
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2024to 30 Oct 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Child, Adult
Study population: Demographic information of all individuals included in the study will be collected. According to the Barcelona Scoliosis Physical Therapy School (BSPTS) Classification by Rigo and Weiss, the diaphragm thickness in patients diagnosed with scoliosis (type 3C and 4C) with thoracic curvature and in the control group was measured in the supine position with a 7-13 Mhz linear conventional ultrasound probe (brand) on the anterior axillary line. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made on the right side and the arithmetic average will be evaluated. Follow-up measurement will be made by the same person, with the same device and with the same method in the 3rd month after the treatment.
Who may be able to join
- Having scoliosis affecting the thoracic region according to BSPTS (type 3C, type 4C and its subtypes)
- Being between the ages of 10-18
- Being able to perform a respiratory function test
- Having the mental capacity to answer surveys
Who cannot join
- Congenital spinal, costal and diaphragmatic anomalies
- Neuromuscular disease
- Respiratory system diseases that affect lung functions
- Patients who cannot cooperate with spirometry.
- Having surgery to the chest wall or spine
Trial locations and contacts
1 site in 1 country.
About this study
Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.
Read the detailed description
Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.
Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale.
The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages.
In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.
- Conditions
- Spine Deformity, Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Diaphragm Issues
- Being tested
- Scoliosis study form, Scoliosis X-ray (orthorontgenogram), Pulmonary function test, Ultrasonographic Measurement, Three-dimensional Exercise (BSPTS Schroth Exercise)
- Keywords
- Adolescent Idiopathic Scoliosis, Diaphragm Thickness, Three-dimensional Exercise (Schroth Exercise), Ultrasonographic Measurement
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis study formDiagnostic test
Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.
Scoliosis X-ray (orthorontgenogram)Diagnostic test
Patients whose Adam's forward bending test and clinical evaluation results are compatible with scoliosis, scoliosis graphy are requested. (Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis film will be requested.).Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs.
Pulmonary function testDiagnostic test
Also called Spirometry Function Test
Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Ultrasonographic MeasurementDiagnostic test
Diaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter- cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Three-dimensional Exercise (BSPTS Schroth Exercise)Procedure or surgery
Also called Physiotherapy Scoliosis Specific Exercises -PSSE (SOSORT Guidelines)
It only provides outpatient treatment, but it has different practices, intensive or regular, depending on local and external patients. For local patients, it is applied once a week, accompanied by a therapist, and the treatment duration is determined according to the patient's condition. In patients coming from outside; It can be continued as 2 hours a day for 10 days, then as additional treatment for 1-2 weeks for 3-6 months depending on the patient's condition. I In regular treatment; 30 sessions of 90 minutes group treatment, the first 8 sessions are carried out under the supervision of a therapist for a shorter period of time.
We will give 10 sessions of BSPTS Schroth exercises, either outpatient or inpatient. After 10 sessions of the Schroth exercise program, the home program will continue two months after outpatient/inpatient schroth exercise(Home program: 5 days/week, 45-60 minutes for all patients).
Home ExerciseProcedure or surgery
In the home exercise program; daily living activities, neutral pelvis exercises, coronal balance exercises, rotational angular breathing exercises and axial elongation exercises were taught by the physiotherapist in one session. A total of 10-week home exercise program was planned, with exercises to be performed twice a week for the first two weeks, once every 15 days for 1 month (twice in one month), and then once a month.
| Study group | Role | What they receive |
|---|---|---|
| Schroth group (Group 1) | Patients aged 10-18 years who are diagnosed with scoliosis and given 10 sessions of schroth exercises, either outpatient or inpatient.
Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. Receives: Diagnostic Test: Scoliosis study form; Diagnostic Test: Scoliosis X-ray (orthorontgenogram); Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Measurement; Procedure: Three-dimensional Exercise (BSPTS Schroth Exercise) | |
| Control group (Group 2) | Patients aged 10-18 years who are diagnosed with scoliosis and given home exercise Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. Receives: Diagnostic Test: Scoliosis study form; Diagnostic Test: Scoliosis X-ray (orthorontgenogram); Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Measurement; Procedure: Home Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis study form
Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.
Measured: Within 2 week of applying to the scoliosis outpatient clinic
Pulmonary function test
We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Measured: Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise
Ultrasonographic Diaphragm Thickness Measurement
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. Diaphragm thickness of End-expiratory (Forced residual capacity-FRC) (millimeter-mm), diaphragm thickness of end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.
Measured: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Secondary outcomes (2)
The Pediatric Quality of Life Inventory
The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition
Measured: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Scoliosis Research Society Score
The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110
Measured: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 May 2024
- Primary completion15 Jul 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spine DeformityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aynur Metin Terzibasioglu, MD,Chief Assistant, Study chair, Maltepe District, Askeri Firin Street, Inistanbul buildins F1 Block Flat: 82 Zeytinburnu /ISTANBULEbru Yilmaz Yalcinkaya, MD,Professor, Study director, Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417944
- Sponsor's protocol ID
- 326
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3.
PubMed 32099278Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7.
PubMed 33550575
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients
- ClinicalTrials.gov ID
- NCT06417944
- Acronym / sponsor ID
- 326
- Conditions
- Spine Deformity, Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Diaphragm Issues
- Keywords
- Adolescent Idiopathic Scoliosis, Diaphragm Thickness, Three-dimensional Exercise (Schroth Exercise), Ultrasonographic Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 14 May 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 16 May 2024 (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.
Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions.Any spinal deformity, especially one that affects the thoracic spine, can affect lung function.In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.
Detailed description
Spinal deformity is common in childhood and adolescence, and can often present as scoliosis or increased thoracic kyphosis deformity with various etiologies.
Any spinal deformity, especially one that affects the thoracic spine, can affect lung function. If left untreated, the curves may distort over time as skeletal growth accelerates. In some patients, this can lead to restrictive or obstructive lung disease and, rarely, death as a result of cor pulmonale.
The alignment of the skeletal system in the chest and its harmony with the compliance of the chest wall are related to respiratory function; Thoracic kyphosis and the resulting changes in the rib cage lead to a decrease in lung capacity. The diaphragm is the main respiratory muscle, and diaphragm contraction is associated with respiratory functions. In recent years, ultrasonography (USG) has gained increasing utility for visualizing the diaphragm and assessing its function, with several advantages.
In the planned thesis study, investigators will measure the diaphragm thickness in adolescent idiopathic scoliosis patients with scoliosis deformities affecting the thoracic region, whether there is any relationship between the impact in the thoracic region and the diaphragm thickness, and the three-dimensional exercise (Schroth exercise-Barcelona Schroth therapy) applied in investigators' clinic for scoliosis, before and after the treatment of the diaphragm. Investigators aimed to show whether there is any change in thickness.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schroth group (Group 1) | – | Diagnostic Test: Scoliosis study form, Diagnostic Test: Scoliosis X-ray (orthorontgenogram), Diagnostic Test: Pulmonary function test, Diagnostic Test: Ultrasonographic Measurement, Procedure: Three-dimensional Exercise (BSPTS Schroth Exercise)Patients aged 10-18 years who are diagnosed with scoliosis and given 10 sessions of schroth exercises, either outpatient or inpatient. Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. |
| Control group (Group 2) | – | Diagnostic Test: Scoliosis study form, Diagnostic Test: Scoliosis X-ray (orthorontgenogram), Diagnostic Test: Pulmonary function test, Diagnostic Test: Ultrasonographic Measurement, Procedure: Home ExercisePatients aged 10-18 years who are diagnosed with scoliosis and given home exercise Scoliosis study forms consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in in detail. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Demographic information of all individuals included in the study will be collected. According to the Barcelona Scoliosis Physical Therapy School (BSPTS) Classification by Rigo and Weiss, the diaphragm thickness in patients diagnosed with scoliosis (type 3C and 4C) with thoracic curvature and in the control group was measured in the supine position with a 7-13 Mhz linear conventional ultrasound probe (brand) on the anterior axillary line. It will be measured at the end of inspiration and expiration from the intercostal space. Three measurements will be made on the right side and the arithmetic average will be evaluated. Follow-up measurement will be made by the same person, with the same device and with the same method in the 3rd month after the treatment.
Key inclusion criteria (4 listed)
- Having scoliosis affecting the thoracic region according to BSPTS (type 3C, type 4C and its subtypes)
- Being between the ages of 10-18
- Being able to perform a respiratory function test
- Having the mental capacity to answer surveys
Key exclusion criteria (5 listed)
- Congenital spinal, costal and diaphragmatic anomalies
- Neuromuscular disease
- Respiratory system diseases that affect lung functions
- Patients who cannot cooperate with spirometry.
- Having surgery to the chest wall or spine
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 |
|---|---|---|
| Scoliosis study formScoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail. | Diagnostic test | Control group (Group 2), Schroth group (Group 1) |
| Scoliosis X-ray (orthorontgenogram)Patients whose Adam's forward bending test and clinical evaluation results are compatible with scoliosis, scoliosis graphy are requested. (Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis film will be requested.).Coronal, sagittal balance; coronal and sagittal Cobb angles will be measured from posterior-anterior (PA) and lateral scoliosis radiographs. | Diagnostic test | Control group (Group 2), Schroth group (Group 1) |
| Pulmonary function testAlso: Spirometry Function TestPulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders. We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second)(L), FEV1 (%predicted), FVC (Forced Vital Capacity) (L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken. | Diagnostic test | Control group (Group 2), Schroth group (Group 1) |
| Ultrasonographic MeasurementDiaphragm thickness will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. End-expiratory (Forced residual capacity-FRC) (centimeter- cm), end-inspiratory (Total Lung Capacity) (centimeter-cm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken. | Diagnostic test | Control group (Group 2), Schroth group (Group 1) |
| Three-dimensional Exercise (BSPTS Schroth Exercise)Also: Physiotherapy Scoliosis Specific Exercises -PSSE (SOSORT Guidelines)It only provides outpatient treatment, but it has different practices, intensive or regular, depending on local and external patients. For local patients, it is applied once a week, accompanied by a therapist, and the treatment duration is determined according to the patient's condition. In patients coming from outside; It can be continued as 2 hours a day for 10 days, then as additional treatment for 1-2 weeks for 3-6 months depending on the patient's condition. I In regular treatment; 30 sessions of 90 minutes group treatment, the first 8 sessions are carried out under the supervision of a therapist for a shorter period of time. We will give 10 sessions of BSPTS Schroth exercises, either outpatient or inpatient. After 10 sessions of the Schroth exercise program, the home program will continue two months after outpatient/inpatient schroth exercise(Home program: 5 days/week, 45-60 minutes for all patients). | Procedure or surgery | Schroth group (Group 1) |
| Home ExerciseIn the home exercise program; daily living activities, neutral pelvis exercises, coronal balance exercises, rotational angular breathing exercises and axial elongation exercises were taught by the physiotherapist in one session. A total of 10-week home exercise program was planned, with exercises to be performed twice a week for the first two weeks, once every 15 days for 1 month (twice in one month), and then once a month. | Procedure or surgery | Control group (Group 2) |
Primary outcome
Scoliosis study form
Time frame: Within 2 week of applying to the scoliosis outpatient clinic
Scoliosis study form consisting of clinical and radiological measurements of patients aged 10-18 years who applied to the outpatient clinic with spine deformity will be filled in detail.
Pulmonary function test
Time frame: Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise
We will use handheld spirometry device for measurement. Three measurements will be made. In these three measurements; FEV1(Forced Expiratory Volume In One Second) (Liter-L), FEV1 (%predicted), FVC (Forced Vital Capacity) (Liter-L), FVC (%predicted), FEV1/FVC (%) and FEV1/FVC (%predicted) will be evaluated. The arithmetic average of the results of these three measurements will be taken.
Ultrasonographic Diaphragm Thickness Measurement
Time frame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Diaphragm thickness (millimeter-mm) will be measured in the supine position with a 6-14 Mhz lineer, conventional ultrasound probe (Mindray DC-8, Shenzen Mindray Bio-Medical Electronics CO. LTD.,P.R. China) at the end of inspiration and expiration from the intercostal space on the anterior axillary line. The measurements will be evaluated by making three measurements from the right 8-9. intercostal space where the diaphragm is best visualized. Diaphragm thickness of End-expiratory (Forced residual capacity-FRC) (millimeter-mm), diaphragm thickness of end-inspiratory (Total Lung Capacity) (millimeter-mm) and thickening rate (%) (thickness TLC / thickness FRC) will be evaluated three times and the arithmetic average of these three measurements will be taken.
2 secondary outcomes
The Pediatric Quality of Life Inventory
Time frame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Scoliosis Research Society Score
Time frame: Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 32099278Jagger F, Tsirikos AI, Blacklock S, Urquhart DS. Adaptation to reduced lung function in children and young people with spinal deformity. J Clin Orthop Trauma. 2020 Mar-Apr;11(2):191-195. doi: 10.1016/j.jcot.2019.12.013. Epub 2020 Jan 3.
- Results publication: PubMed 33550575Karaali E, Ciloglu O, Gorgulu FF, Ekiz T. Ultrasonographic measurement of diaphragm thickness in patients with severe thoracic scoliosis. J Ultrasound. 2021 Mar;24(1):75-79. doi: 10.1007/s40477-020-00536-w. Epub 2021 Feb 7.
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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. This study is not recruiting at the moment.
Aynur Metin Terzibasioglu, MD,Chief Assistant study chair
Maltepe District, Askeri Firin Street, Inistanbul buildins F1 Block Flat: 82 Zeytinburnu /ISTANBUL
Ebru Yilmaz Yalcinkaya, MD,Professor study director
Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Deformity and Scoliosis, run by Gaziosmanpasa Research and Education Hospital 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis study form (time frame: Within 2 week of applying to the scoliosis outpatient clinic). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417944, which also lists 2 linked publications.
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 7 Jan 2025.