- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06803121
The Effect of Core Stability Exercises on Idiopathic Scoliosis in Adolescent Females
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Scoliosis is a disease in which the spine deviates or rotates laterally from its normal vertical line, and it can cause decreased spinal movement, weakening of muscles near the spine, reduced pulmonary function, respiratory dysfunction, chronic pain, and psychological suffering. Scoliosis can be classified as idiopathic, congenital, neurofibromatosis, and neuromuscular. Among these types of scoliosis, approximately 80% of patients with scoliosis have AIS, which typically occurs around 10 years of age when healthy bone maturation occurs during adolescence. IS is diagnosed when there are no known causes besides spinal deformity involving a lateral curvature with a Cobb angle ≥10°.
Therapeutic approaches for IS include surgical and conservative treatments. Exercise therapy for IS is considered important for maintaining spinal function when the Cobb angle is <20°. Moreover, the effects of core stabilization exercise have been demonstrated recently for alleviating chronic lower back pain in patients, improving performance in athletes, and preventing sports injuries in athletes. Based on this information, core stabilization exercise may be used effectively to improve neuromuscular imbalance, which is the cause of IS. However, studies on the therapeutic effects of using core stabilization exercise in patients with AIS are still lacking.
Accordingly, the objective of this study is to evaluate the efficacy of core stability exercises on curve magnitude, posture, trunk deformity, and quality of life in adolescent females with idiopathic scoliosis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Al Azhar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Their ages will be ranged from 10-19 years.
- All adolescent Females will be diagnosed as idiopathic scoliosis with S shape.
- Cobb angle on anterior-posterior radiograph will be used in the assessment of thoracic and lumbar cure of each patient in this study.
- All adolescent females are not under any other treatment method for idiopathic scoliosis.
- Willingness and ability to comply with the study requirements and give informed consent.
Exclusion Criteria:
- Patients with a history of rheumatologic, neuromuscular, cardiovascular, pulmonary, or renal diseases.
- Patients with congenital scoliosis or spinal deformity.
- Patients who had undergone surgical correction of the spine.
- Patients with a tumor.
- Enrollment in any other clinical trial during the time of this trial.
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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Active Comparator: Traditional treatment
It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing), two sessions per week for three months (24 sessions).
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Traditional exercises for scoliosis include breathing exercises, posture training, spinal flexibility exercises, stretching exercises for the involved muscles (especially for the concave side of the curve), and general strengthening exercises for the main muscle groups of trunk, pelvis, and shoulder girdle muscles (especially for the convex side of the curve).
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Experimental: Traditional treatment + Core stability exercises
It will be consisted of thirty adolescent females with idiopathic scoliosis and will be treated by traditional treatment (traditional exercises and bracing) in addition to core stability exercises, two sessions per week for three months (24 sessions).
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Traditional exercises for scoliosis include breathing exercises, posture training, spinal flexibility exercises, stretching exercises for the involved muscles (especially for the concave side of the curve), and general strengthening exercises for the main muscle groups of trunk, pelvis, and shoulder girdle muscles (especially for the convex side of the curve).
The CS training program includes local muscle stability training (transverses abdominis, multifidus, and diaphragm), global muscle stability training (oblique abdominal muscles, psoas major, quadratus lumborum, and pelvic floor muscles), global muscle mobility training (rectus abdominis, back extensors, and hamstring muscles), and strength training of the core muscles through the thoracolumbar fascia by maintaining the neutral spine position.
Diaphragmatic breathing technique will be used during exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of Cobb angles
Time Frame: 3 months
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Cobb angles on anterior and posterior spine radiographs taken in standing position.
The Cobb angle is the angle between two lines, drawn perpendicular to the upper endplate of the uppermost vertebra involved and the lower endplate of the lowest vertebra involved.
Once a patient's Cobb angle is determined, the condition can be further classified on its severity scale of mild, moderate, or severe.
Cobb angles will be assessed for all adolescent females in both groups A & B before and after treatment.
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3 months
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Measurement of trunk asymmetry in scoliosis
Time Frame: 3 months
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A scoliometer is an instrument that measures trunk asymmetry in scoliosis, or angle of trunk rotation (ATR).
It is a small, non-invasive device (essentially a mini-level) that is placed over the spine while a person is in a forward bending position.
The scoliometer reading indicates degree of trunk asymmetry (rotation).
Generally, an angle of trunk rotation that is less than 5 degrees is insignificant and may not require follow-up.
A measurement of 5 to 9 degrees at least warrants reexamination in six months.
A measurement of 10 degrees or greater requires radiologic evaluation for Cobb angle measurement.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trunk appearance perception scale (TAPS)
Time Frame: 3 months
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TAPS includes 3 sets of figures that depict the trunk from 3 viewpoints: looking toward the back, looking toward the head with the patient bending over (Adam's test), and looking toward the front.
This last view has two sets of drawings, one for males and one for females.
Each drawing is scored from 1 (greatest deformity) to 5 (smallest deformity) and a mean score is obtained by adding the scores for the 3 drawings and dividing by 3.
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3 months
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The Scoliosis research society-22 questionnaire (SRS-22)
Time Frame: 3 months
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The SRS-22 contains 22 questions covering 5 domains: function/activity, 5 items; pain, 5 items; self-perceived body image, 5 items; mental health, 5 items; and satisfaction with treatment, 2 items.
The satisfaction scale was not used in the present study.
Each item is scored from 1 (worst) to 5 (best).
In the present study, the results are expressed as the mean for each domain (total sum of the domain divided by the number of items answered) and the total score.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mohamed Ahmed Mohamed Awad, PhD, Professor, Cairo university
- Study Director: Afaf Mohamed Mahmoud Botla, PhD, Assistant Professor, Cairo 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
- P.T.REC/012/004728
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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