- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557773
The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis
Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°.
Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance.
Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance.
The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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 10-18
- Cobb angle is between 10-40 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.
|
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 |
|---|---|---|
|
Balance
Time Frame: 8 week
|
Evaluation of balance with Biodex Balance System
|
8 week
|
|
Proprioception
Time Frame: 8 week
|
Evaluation of proprioception with Biodex System 3 Pro Multijoint System
|
8 week
|
|
Muscle Strength of Knee Flexion / Extension
Time Frame: 8 week
|
Muscle Strength of Knee Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.e
Flexion / Extension
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 8 week
|
Evaluation of balance with Modified Romberg test
|
8 week
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUFGokdemir02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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