- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06682702
Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises With Schroth in Adolescent Idiopathic Scoliosis
The Effectiveness of Dynamic Neuromuscular Stabilization Breathing Exercises in Addition to Schroth Exercises in Individuals With Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this randomized controlled trial, we aim to assess various physical and quality of life parameters in volunteers with scoliosis. The degree of spinal curvature will be measured using full body standing X-rays, providing a detailed assessment of the scoliosis angle. Additionally, the rotation degree of the spinal curvature will be evaluated with a scoliosis meter during the forward bending test, which is commonly used to gauge the rotational component of scoliosis.
Quality of life will be assessed using the Scoliosis Research Society-22 (SRS-22) questionnaire, a validated tool consisting of 22 questions designed to evaluate function, pain, self image, mental health, and satisfaction in individuals with scoliosis. To quantify pain levels experienced due to scoliosis, the Visual Analog Scale (VAS) will be used, in which participants mark their pain intensity on a 10 centimeter line, ranging from "no pain" to "worst pain imaginable." This provides an accurate, subjective measure of pain severity.
Breathing patterns will also be evaluated by measuring the volunteers' chest circumference at full inspiration and expiration using a standard tape measure, allowing us to assess any potential restrictions in lung expansion related to the spinal curvature. Through this comprehensive evaluation, we hope to gain a clearer understanding of how scoliosis affects both the physical and psychological well being of individuals and identify potential areas for therapeutic intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Uskudar University Physiotherapy and Rehabilitation Application and Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Radiologically measured Cobb angle value between 10 degrees and 50 degrees
- Age between 10 and 18
- Being diagnosed with Adolescent Idiopathic Scoliosis by a physician
- Being between 0 and 5 in the radiologically determined Risser sign
- Being between 12-25 kg/m2 according to body mass index measurement
Exclusion Criteria:
- Having had any surgery related to scoliosis
- Having been diagnosed with any psychiatric disease
- Having been diagnosed with an oncological disease
- Having a neurological disease, vestibular or visual problem
- Having any pathology that will affect motor performance
- Using medication that affects the central nervous system
- Having been diagnosed with a rheumatological disease
- Having been diagnosed with any cardiovascular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: DNS Group
Patients diagnosed with adolescent idiopathic scoliosis participated in sessions twice a week for 8 weeks, with each session lasting 45 minutes.
During the sessions, ISST Schroth exercises were combined with dynamic neuromuscular stabilization exercises.
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ISST Schroth exercises are a model of exercise aimed at correcting scoliosis in three dimensions.
Dynamic neuromuscular stabilization exercises, on the other hand, are designed to achieve sagittal stabilization by utilizing the stabilizing function of the thoracic diaphragm muscle.
Other Names:
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Experimental: Schroth Group
Patients diagnosed with adolescent idiopathic scoliosis participated in sessions twice a week for 8 weeks, with each session lasting 45 minutes.
During the sessions, ISST Schroth exercises were performed.
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ISST Schroth exercises are a model of exercise aimed at correcting scoliosis in three dimensions.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cobb Angel
Time Frame: 8 weeks
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The Cobb angle will be measured using standing full-spine X-rays to quantify the degree of spinal curvature in patients with scoliosis.
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8 weeks
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Respiratory Muscle Strength
Time Frame: 8 weeks
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Respiratory muscle strength was measured using an electronic mouth pressure measuring device (Cosmed Ponyy Fx, Rome, Italy).
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were measured.
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8 weeks
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Angle Trunk Rotation
Time Frame: 8 weeks
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The Adams forward bending test, commonly used in scoliosis screening, involves positioning the patient with arms extended forward to assess for asymmetric protrusions and coronal imbalance in the back, while a scoliometer is utilized to measure the degree of spinal rotation and track progression of trunk asymmetry and deformity.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale
Time Frame: 8 weeks
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The Visual Analog Scale (VAS) will be used to measure pain intensity by having participants mark their perceived level of pain on a 10-centimeter line ranging from 'no pain' to 'worst pain imaginable.
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8 weeks
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Scoliosis Research Society-22 (SRS-22) Quality of Life Questionnaire
Time Frame: 8 weeks
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The Scoliosis Research Society-22 (SRS-22) Quality of Life Questionnaire measures the impact of scoliosis on patients' quality of life across five domains: function, pain, self-image, mental health, and satisfaction, using a total of 22 questions.
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Filiz Eyuboglu, PhD., Uskudar University
- Principal Investigator: Mert Ilhan, MSc., Uskudar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-PT-MRVB-RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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