## Protocol Section
### Identification Module
**NCT ID:** NCT06417944

**Brief Title:** The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients

**Official Title:** The Effect of Three-dimensional Exercise (Schroth Exercise) on Diaphragm Thickness in Adolescent Idiopathic Scoliosis Patients

#### Organization Study ID Info
**ID:** 326
#### Organization
**Class:** OTHER_GOV
**Full Name:** Gaziosmanpasa Research and Education Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-28
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Gaziosmanpasa Research and Education Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 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.

### Conditions Module

**Conditions:**

- Spine Deformity

- Scoliosis

- Scoliosis Idiopathic

- Scoliosis; Adolescence

- Diaphragm Issues

**Keywords:**

- Adolescent Idiopathic Scoliosis

- Diaphragm Thickness

- Three-dimensional Exercise (Schroth Exercise)

- Ultrasonographic Measurement

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Months

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- 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)

**Label:** Schroth group (Group 1)

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Scoliosis study form

- Diagnostic Test: Scoliosis X-ray (orthorontgenogram)

- Diagnostic Test: Pulmonary function test

- Diagnostic Test: Ultrasonographic Measurement

- Procedure: Home Exercise

**Label:** Control group (Group 2)

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group (Group 2)

- Schroth group (Group 1)

**Description:** 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.

**Name:** Scoliosis study form

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Control group (Group 2)

- Schroth group (Group 1)

**Description:** 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.

**Name:** Scoliosis X-ray (orthorontgenogram)

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- Control group (Group 2)

- Schroth group (Group 1)

**Description:** 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.

**Name:** Pulmonary function test

**Other Names:**

- Spirometry Function Test

**Type:** DIAGNOSTIC_TEST

#### Intervention 4

**Arm Group Labels:**

- Control group (Group 2)

- Schroth group (Group 1)

**Description:** 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.

**Name:** Ultrasonographic Measurement

**Type:** DIAGNOSTIC_TEST

#### Intervention 5

**Arm Group Labels:**

- Schroth group (Group 1)

**Description:** 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).

**Name:** Three-dimensional Exercise (BSPTS Schroth Exercise)

**Other Names:**

- Physiotherapy Scoliosis Specific Exercises -PSSE (SOSORT Guidelines)

**Type:** PROCEDURE

#### Intervention 6

**Arm Group Labels:**

- Control group (Group 2)

**Description:** 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.

**Name:** Home Exercise

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Scoliosis study form

**Time Frame:** Within 2 week of applying to the scoliosis outpatient clinic

**Description:** 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.

**Measure:** Pulmonary function test

**Time Frame:** Within 2 weeks after applying to the scoliosis clinic (pre-exercise) and 3 months after exercise

**Description:** 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.

**Measure:** Ultrasonographic Diaphragm Thickness Measurement

**Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise

#### Secondary Outcomes

**Description:** 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

**Measure:** The Pediatric Quality of Life Inventory

**Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise

**Description:** 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

**Measure:** Scoliosis Research Society Score

**Time Frame:** Within 2 weeks after applying to the scoliosis clinic(pre-exercise) and 3 months after exercise

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 10 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ofalp3456@gmail.com

**Name:** Omer Faruk Alp, MD

**Phone:** +90 541 785 10 26

**Role:** CONTACT

**Contact 2:**

**Email:** dr_denizoke@hotmail.com

**Name:** Deniz Oke, MD

**Phone:** +90 532 430 69 50

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** dr_denizoke@hotmail.com

- **Name:** Deniz Oke, MD

- **Phone:** +90 532 430 69 50

- **Role:** CONTACT

***Contact 2:***

- **Email:** ebru.yilmaz.yalcinkaya@gmail.com

- **Name:** Ebru Yilmaz Yalcinkaya, MD,Professor

- **Phone:** +90 505 451 85 73

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Omer Faruk Alp

**State:** Gaziosmanpasa

**Status:** RECRUITING

**Zip:** 34255

#### Overall Officials

**Official 1:**

**Affiliation:** Maltepe District, Askeri Firin Street, Inistanbul buildins F1 Block Flat: 82 Zeytinburnu /ISTANBUL

**Name:** Aynur Metin Terzibasioglu, MD,Chief Assistant

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department

**Name:** Ebru Yilmaz Yalcinkaya, MD,Professor

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 32099278

**Citation:** Karaali 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.

**PMID:** 33550575

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013121

- Term: Spinal Curvatures

- ID: D000013122

- Term: Spinal Diseases

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M15417

- Name: Scoliosis

- Relevance: HIGH

- As Found: Scoliosis

- ID: M15918

- Name: Spinal Curvatures

- Relevance: LOW

- As Found: Unknown

- ID: M15919

- Name: Spinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012600

- Term: Scoliosis

### Misc Info Module

- Version Holder: 2024-05-31
