The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Based Traditional Scoliosis Exercises
Core Stability Training
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Isokinetic Testing, EMG Biofeedback, Core Stability
Eligibility Criteria
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.
Sites / Locations
- Istanbul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Training Group
Arm Description
The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.
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.
Outcomes
Primary Outcome Measures
Muscle Strength of Trunk Flexion / Extension
Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Muscle Strength of Knee Flexion / Extension
Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Muscle Strength
Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Muscle Electromyographic Activity
Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Secondary Outcome Measures
Trunk Rotation
Evaluation of the thoracic, thoracic-lumber junction, lumber axial trunk rotation with Bunnell Scoliometer
Patients Quality of Life
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.
Cosmetic Deformity Evaluation
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).
Flexibility Measurement
Patients flexibility will be measured with forward and lateral bending tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05056363
Brief Title
The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis
Official Title
In The Light of Isokinetic Test and sEMG: How Effective Is Core Stability Exercise Training On Muscle Strenght and Quality of Life In Adolescent Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Isokinetic Testing, EMG Biofeedback, Core Stability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Based Traditional Scoliosis Exercises
Intervention Description
Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
Intervention Type
Other
Intervention Name(s)
Core Stability Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Strength of Trunk Flexion / Extension
Description
Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Time Frame
8 week
Title
Muscle Strength of Knee Flexion / Extension
Description
Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Time Frame
8 week
Title
Muscle Strength
Description
Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Time Frame
8 week
Title
Muscle Electromyographic Activity
Description
Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Trunk Rotation
Description
Evaluation of the thoracic, thoracic-lumber junction, lumber axial trunk rotation with Bunnell Scoliometer
Time Frame
8 week
Title
Patients Quality of Life
Description
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.
Time Frame
8 week
Title
Cosmetic Deformity Evaluation
Description
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).
Time Frame
8 week
Title
Flexibility Measurement
Description
Patients flexibility will be measured with forward and lateral bending tests
Time Frame
8 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuat Gökdemir
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Core Stability Training in Children With Adolescent Idiopathic Scoliosis
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