- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07683533
Three-Dimensional Scoliosis Exercises and Diaphragmatic Manual Techniques in Adolescents With Idiopathic Scoliosis
The Effectiveness of Three-Dimensional Scoliosis Exercises Supported by Diaphragmatic Manual Techniques in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Adolescent idiopathic scoliosis is characterized by a three-dimensional deformity of the spine and can cause changes in muscle strength, muscle activation, trunk stability, and respiratory function. Considering the role of the diaphragm muscle in postural control and spinal stabilization, it is thought that disorders in diaphragmatic function may contribute to scoliosis progression. Three-dimensional scoliosis exercises (Schroth exercises), with their three-dimensional correction principles and rotational breathing techniques, are frequently used in scoliosis rehabilitation. However, the effects of supplementing Schroth exercises with diaphragmatic manual techniques on muscle activation and trunk derotation have not been sufficiently clarified. The results of this study are expected to contribute to determining the effectiveness of breath-based manual approaches in scoliosis rehabilitation and to provide a scientific basis for physiotherapy applications. Although there are studies in the literature examining the effects of Schroth exercises on curvature angle, posture, and quality of life, studies investigating the effects of applying diaphragmatic manual techniques in conjunction with Schroth exercises on electromyographic muscle activation and derotation are limited. Adolescent idiopathic scoliosis is a progressive musculoskeletal problem that emerges during the growth period and is characterized by a three-dimensional deformity of the spine. Lateral curvature, vertebral rotation, and trunk asymmetry in the spine can negatively affect individuals' postural control, respiratory functions, and muscle activation patterns. In recent years, three-dimensional scoliosis exercises and brace therapy have become widely used among conservative treatment methods, and these approaches have been reported to be effective in reducing curvature progression. However, the effects of diaphragmatic manual techniques on respiratory mechanics, trunk stabilization, and muscle activation, and the results of their combined use with three-dimensional scoliosis exercises, have not yet been sufficiently investigated. This study aims to investigate the effects of diaphragmatic manual techniques and 3D scoliosis exercises, applied for 12 weeks, on superficial muscle activity, scoliosis severity, trunk rotation angle, perception of cosmetic deformity, respiratory function, respiratory muscle strength, and quality of life in individuals with adolescent idiopathic scoliosis.
Although there are studies in the literature examining the effects of 3D scoliosis exercises on curvature angle, posture, and quality of life, studies evaluating the effects of applying diaphragmatic manual techniques in conjunction with 3D scoliosis exercises on EMG activation, scoliosis severity, trunk rotation angle, perception of cosmetic deformity, respiratory function, respiratory muscle strength, and quality of life are limited. Therefore, the aim of this research is to contribute to the development of new rehabilitation approaches in the conservative treatment of adolescent idiopathic scoliosis.This study aims to investigate the effects of diaphragmatic manual techniques and 3D scoliosis exercises, applied for 12 weeks, on superficial muscle activity, scoliosis severity, trunk rotation angle, perception of cosmetic deformity, respiratory function, respiratory muscle strength, and quality of life in individuals with adolescent idiopathic scoliosis. Although there are studies in the literature examining the effects of 3D scoliosis exercises on curvature angle, posture, and quality of life, studies evaluating the effects of applying diaphragmatic manual techniques in conjunction with 3D scoliosis exercises on EMG activation, scoliosis severity, trunk rotation angle, perception of cosmetic deformity, respiratory function, respiratory muscle strength, and quality of life are limited. Therefore, the aim of this research is to contribute to the development of new rehabilitation approaches in the conservative treatment of adolescent idiopathic scoliosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neriman Temel Aksu
- Phone Number: +905052973906
- Email: nerimantemelaksu@akdeniz.edu.tr
Study Contact Backup
- Name: Açelya Kocabey
- Phone Number: 05332786187
Study Locations
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Konyaaltı
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Antalya, Konyaaltı, Turkey (Türkiye), 07070
- Akdeniz University
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Contact:
- Neriman Temel Aksu
- Phone Number: 05052973906
- Email: nerimantemelaksu@akdeniz.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals aged 10-18 years, in adolescence.
- Scoliosis curvature in the thoracic region.
- Individuals and their parents (those who have signed the informed consent form) who agree to participate in regular follow-up and exercise programs throughout the study period.
- Diagnosis of AIS by a physician.
- Patients with idiopathic scoliosis diagnosed radiologically and with a Cobb angle less than 30°.
- The child and family agree to participate in and adhere to the 12-week treatment process.
- Ability to understand and speak Turkish.
- Not being in another treatment program. Individuals without any systemic disease that prevents participation in the physical exercise program.
Exclusion Criteria:
- Individuals who report that they cannot participate regularly during the exercise period or who will not adhere to the study schedule.
- Individuals who have not previously undergone surgery for scoliosis
- Those with accompanying neuromuscular or rheumatic diseases
- Those receiving other scoliosis-related treatment during the study
- Malignancy
- Those using braces
- Individuals with cognitive impairment that prevents them from understanding and performing the exercises mentally or physically.
- Those with respiratory and cardiovascular system diseases requiring regular medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Diaphragmatic manual techniques and Schroth exercises
The Diaphragmatic manual techniques and Schroth exercises group will receive 15 minutes of diaphragmatic manual techniques followed by 45 minutes of Schroth exercises.
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With the patient sitting upright, the physiotherapist will position themselves behind the patient, placing their hands across the rib cage and fingertips to the subcostal margins.
As the patient exhales, the physiotherapist will apply gentle but firm lateral pulling force from the subcostal margin to stretch the diaphragm.
This pulling will be continued during inhalation.
After repeating this for several breathing cycles, the patient will be placed supine, with hands bilaterally placed on the lower ribs, and mobilization will be performed in a figure-eight pattern.
For diaphragm mobilization, individuals will lie comfortably on their backs.
The physiotherapist, positioned above the individual's head, will place the hypothenar region and the last three fingers of their hands bilaterally on the 7th-10th costal cartilages.
The therapist will apply lateral and longitudinal pulls with their hands to support rib elevation during inspiration.
During a Schroth exercise session, the goal is to stabilize proper posture by lengthening shortened muscles and activating stretched muscles through rotational breathing, based on the principles of active elongation, deflection, and derotation postural correction.
Individuals will be positioned in three different positions-sleeping, sitting, and standing-with passive or active support, and stabilization will be achieved through isometric stretching.
Each position will be held for 10 breaths*3 sets, and the therapist will monitor the corrections throughout the session.
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Active Comparator: Schroth exercises
Patients in the Schroth exercises group will only perform Schroth exercises for 60 minutes.
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During a Schroth exercise session, the goal is to stabilize proper posture by lengthening shortened muscles and activating stretched muscles through rotational breathing, based on the principles of active elongation, deflection, and derotation postural correction.
Individuals will be positioned in three different positions-sleeping, sitting, and standing-with passive or active support, and stabilization will be achieved through isometric stretching.
Each position will be held for 10 breaths*3 sets, and the therapist will monitor the corrections throughout the session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Ossification of the Iliac Apophysis
Time Frame: Changes from baseline Ossification of the Iliac Apophysis at 12 weeks.
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Evaluation of skeletal maturation is necessary to determine the patient's risk of progression. Risser grading is one of the most commonly used methods for measuring ossification of the iliac apophysis. Stage 0: No ossification Stage 1: Ossification of up to 25% of the iliac apophysis Stage 2: Ossification of 25% to 50% of the iliac apophysis Stage 3: Ossification of 50% to 75% of the iliac apophysis Stage 4: Ossification of more than 75% of the iliac apophysis Stage 5: Complete bone fusion of the iliac apophysis Growth is not considered complete until Stage 5 is reached; therefore, one of the inclusion criteria for the study is a maximum Risser stage of 4. |
Changes from baseline Ossification of the Iliac Apophysis at 12 weeks.
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Change of Severity of Scoliosis
Time Frame: Change from baseline severity of scoliosis at 12 weeks.
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The Cobb angle is an angle method that radiologically measures the degree of curvature.
This angle is based on the angle between the top and bottom edges of the spinal segments at the beginning and end of the curvature.
On the X-ray, the top and bottom vertebrae that form the spinal curve are selected.
These vertebrae represent the beginning and ending points of the curvature.
The top and bottom edges of each selected vertebra are drawn with lines, and an angle is measured through the intersection of these lines.
This angle is considered the Cobb angle.
Scoliosis can be diagnosed when the curvature in the spine is more than 10 degrees.
If the Cobb angle is 10 degrees or more, this curvature is considered scoliosis.
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Change from baseline severity of scoliosis at 12 weeks.
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Change of Trunk Rotation Angle
Time Frame: Change from baseline trunk rotation angle at 12 weeks.
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Trunk rotation angle (ATR) will be measured using a Bunnell scoliometer.
Frequently used to assess scoliosis progression and treatment effectiveness, the Bunnell scoliometer is an inclinometer known for its ease of use, low cost, and reliability.
Measurements are taken by placing the scoliometer vertically along the axial axis of the vertebral column, perpendicular to the spinous processes of the vertebrae.
In our study, assessments with the scoliometer will be performed in a standing forward-bend position.
Patients will be asked to bend forward until the trunk is in a horizontal position and the scapula and pelvis are aligned.
Care will be taken to ensure that the patients' arms are relaxed in this position.
The highest rotation angle value obtained from the thoracic, thoracolumbar, and lumbar regions of the spine will be noted.
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Change from baseline trunk rotation angle at 12 weeks.
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Change of Cosmetic Deformity Perception
Time Frame: Changes from baseline Cosmetic Deformity Perception at 12 weeks.
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Patients' perception of cosmetic deformity will be assessed using the WRVAS (Walter Reed Visual Assessment Scale).
WRVAS is a visual scale designed for patients with idiopathic scoliosis to describe how they perceive their own deformity.
The scale categorizes deformity into 7 different aspects.
Each of the 7 items includes a set of 5 figures representing the severity of the deformity.
These sets contain visuals that assess spinal deformity, rib protrusion, lumbar protrusion, chest deformity, trunk imbalance, shoulder asymmetry, and scapular asymmetry.
The visuals include posterior views of the deformity and assess how the patient feels about how others see their own back.
Selected visuals are scored from a minimum of "1" to a maximum of "5".
The results are used to understand the visual changes caused by scoliosis, as well as to monitor treatment outcomes.
Reliability and validity studies were conducted on the Turkish version of the scale
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Changes from baseline Cosmetic Deformity Perception at 12 weeks.
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Change of Quality of Life
Time Frame: Change from Baseline Quality of Life at 12 weeks.
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The Scoliosis Research Society-22 (SRS-22) questionnaire is a widely used self-report scale developed to assess quality of life in individuals with adolescent idiopathic scoliosis and adult spinal deformities for clinical and research purposes.
Originally derived from the SRS-24 version, this form has been simplified to shorten assessment time and reduce patient burden.
Today, it is used as a standardized tool to understand how scoliosis affects an individual's daily life.
Each item is evaluated using a Likert-type response scale scored from 1 (worst case) to 5 (best case).
Higher scores indicate better quality of life.
For example, a question such as "To what extent does your back pain affect your daily activities?" quantitatively reflects the impact of the pain experienced by the individual on daily functioning.
In the overall scoring of the questionnaire, excluding the treatment satisfaction dimension, average sub-dimension scores are obtained out of 20 items.
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Change from Baseline Quality of Life at 12 weeks.
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Change of Electromyographic Activity of Muscles
Time Frame: Change from Baseline Electromyographic Activities of Muscles at 12 weeks.
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Muscles produce myoelectric potentials during contraction.
Electromyography (EMG) is an evaluation method to determine the magnitude of this electrical activity of the muscle.
Surface EMG signals are obtained with surface electrodes placed on the muscle body.
High-magnitude EMG signals indicate that numerous motor units are firing.
The magnitude of EMG signals provides information about how well the person can use the muscles being evaluated and the strength of the relevant muscle.
Individuals with adolescent idiopathic scoliosis have asymmetric use and loss of strength in muscles.
The main goal of the exercises used in treatment is to increase muscle strength, reduce asymmetric use, and increase the usability of the muscles.
Evaluations will be performed with the wireless BTS FreeEMG-1000 system (BTS Engineering Corp.) electromyography device.
The system has a miniaturized wireless surface EMG probe with Snap-On active electrodes that receive and transmit the signal in real time, and
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Change from Baseline Electromyographic Activities of Muscles at 12 weeks.
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Change of Pulmonary Function
Time Frame: Change from Baseline Pulmonary Function at 8 weeks.
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Description: The Pulmonary Function Test will be performed with the COSMED Pony FX (COSMED; Italy) spirometer in accordance with the criteria of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Forced vital capacity (FVC), Forced expiratory volume in 1 second (FEV1), Tiffeneau ratio (FEV1/FVC), Forced expiratory flow 25-75% (FEF25-75%) and peak expiratory flow rate (PEF) values and predictive values percentage will be recorded.
Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.
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Change from Baseline Pulmonary Function at 8 weeks.
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Change of Respiratory Muscle Strength
Time Frame: Change from Baseline Respiratory Muscle Strength at 12 weeks.
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Respiratory muscle strength measurement will be performed with a portable, electronic intraoral pressure measuring device COSMED Pony FX (COSMED; Italy) according to ATS/ERS criteria.
The MIP will be measured at residual volume and during deep inspiration.
MEP will be determined at total lung capacity and during deep expiration.
Measurements will be made in a sitting position using a nose clip.
Patients will be verbally encouraged for the best strength.
Measurement will be made until it provides the valid value in patients.
Preoperative period, postoperative 7th day, postoperative 4th week and postoperative 8th week will be repeated.
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Change from Baseline Respiratory Muscle Strength at 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Height in Meters
Time Frame: Initial assessment before surgery
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The height of all subjects in meters (m) will be noted before the surgery.
Height will be combined to report BMI in kg/m^2
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Initial assessment before surgery
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Weight in Kilograms
Time Frame: Initial assessment before surgery
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The weight of all subjects in kilograms (kg) will be noted before the surgery.
Weight will be combined to report BMI in kg/m^2.
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Initial assessment before surgery
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Body Mass Index (BMI) in kg/m^2
Time Frame: Initial assessment before surgery
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Description: Body Mass Index (BMI) will be calculated with the formula weight (kg)/height (m)^2.
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Initial assessment before surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neriman Temel Aksu, Akdeniz 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
- akdenizscoliosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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