- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056363
The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis
In The Light of Isokinetic Test and sEMG: How Effective Is Core Stability Exercise Training On Cobb Angle Muscle Strenght and Quality of Life In Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems.
Core stability training may have a positive effect for these problems experienced by children with AIS.
Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing.
The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Fatih
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Istanbul, Fatih, Turkey, 34093
- Istanbul University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with AIS between the ages of 10-20
- Cobb angle is between 15-40 degrees
- The child's and family's consent to participate in the study
- The child does not receive any other treatment that will affect his scoliosis.
Exclusion Criteria:
- Surgical operation in the last 3 months
- Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
- Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
- Exercising 3 or more days a week.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.
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Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
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Experimental: Training Group
In addition to conventional home based traditional scoliosis exercises, patients in this group will also receive core stabilization exercise training for 45 minutes, 5 times in a week for 8 weeks.
Every two sessions will be supervised in a clinic per week.
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Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
Patients in this group will receive traditional scoliosis exercises.
In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: 8 week
|
Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
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8 week
|
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Muscle Electromyographic Activity
Time Frame: 8 week
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Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
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8 week
|
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Muscle Strength of Trunk Flexion / Extension
Time Frame: 8 week
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Measurement of isokinetic and isometric muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
|
8 week
|
|
Cobb Angle
Time Frame: 8 week
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Cobb Angle measurement with AP Radiography
|
8 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Rotation
Time Frame: 8 week
|
Evaluation of the thoracic, thoracic-lumber junction, lumber axial trunk rotation with Bunnell Scoliometer
|
8 week
|
|
Patients Quality of Life
Time Frame: 8 week
|
Quality of life will be measured with using the Scoliosis Research Society 22 item questionnaire (SRS-22r). SRS-22 has a minimum score of 22 and a maximum score of 110. Each question is scored on 1-5 scale. Questions are sorted into different domains and total and mean scores for each domain are calculated. A total score for the entire questionnaire is also calculated. |
8 week
|
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Cosmetic Deformity Evaluation
Time Frame: 8 week
|
Patients cosmetic deformity will be evaluated with Walter Reed Visuel Assesment Scale. This scale includes seven items with figures representing different aspects of the spinal deformity: spinal deformity, rib prominence, lumbar prominence, thoracic deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The figures are scored from minimum (1, no deformity) to maximum (5, severe deformity) and summed up to yield a total score (minimum: 5 points, maximum: 35 points). |
8 week
|
|
Flexibility Measurement
Time Frame: 8 week
|
Patients flexibility will be measured with forward and lateral bending tests
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fuat Gökdemir, Istanbul 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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUFGokdemir01
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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