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

NCT06417944 | Completed

• 1 other identifier: 326
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Deformity; Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence; Diaphragm Issues

Keywords

Adolescent Idiopathic Scoliosis; Diaphragm Thickness; Three-dimensional Exercise (Schroth Exercise); Ultrasonographic Measurement

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

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

• Scoliosis Research Society Score

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

Study Arms (2)

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.

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.

Diagnostic Test: Scoliosis study form; Diagnostic Test: Scoliosis X-ray (orthorontgenogram); Diagnostic Test: Pulmonary function test; Diagnostic Test: Ultrasonographic Measurement; Procedure: Home Exercise

Interventions

Scoliosis study form DIAGNOSTIC_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.

Control group (Group 2); Schroth group (Group 1)

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.

Control group (Group 2); Schroth group (Group 1)

Pulmonary function test DIAGNOSTIC_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.

Also known as: Spirometry Function Test

Control group (Group 2); Schroth group (Group 1)

Ultrasonographic Measurement DIAGNOSTIC_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.

Control group (Group 2); Schroth group (Group 1)

Three-dimensional Exercise (BSPTS Schroth Exercise) PROCEDURE

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).

Also known as: Physiotherapy Scoliosis Specific Exercises -PSSE (SOSORT Guidelines)

Schroth group (Group 1)

Home Exercise PROCEDURE

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.

Control group (Group 2)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Omer Faruk Alp

Istanbul, Gaziosmanpasa, 34255, Turkey (Türkiye)

Location

Related Publications (2)

• 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 BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Scoliosis

Interventions

Respiratory Function Tests

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Aynur Metin Terzibasioglu, MD,Chief Assistant

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

  STUDY CHAIR

• Ebru Yilmaz Yalcinkaya, MD,Professor

  Gaziosmanpaşa Training and Research Hospital Physical Rehabilitation Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 16, 2024
• Study Start: May 14, 2024
• Primary Completion: July 15, 2024
• Study Completion: October 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-04

Locations

TU (1)