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Completed

NCT Number: NCT02978820

The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). The objective of this study was to compare the effects of Core stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to brace wearing in patients with AIS. It is important to compare different exercise methods on different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.

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Key information

Age range

12 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The aim of this study was to investigate whether adolescent with idiopathic scoliosis receiving scoliosis specific exercise approach, such as SEAS exercises, in accordance with the bracing approach for moderate curves would have greater improvement in curve progression, trunk deformity, body symmetry and quality of life than adolescent receiving exercise therapy based on the general core stabilization approach with similar intensity. Thirty female patients with AIS aged 12 to16 years, who have moderate curves (20 to 45 degree) randomly divided into two groups. One group received CS exercise, while other received SEAS exercise for forty-min once weekly for four months. Both groups underwent full-time bracing (23 hours per day) intervention. Outcome was based on Cobb angle, angle of trunk rotation, body symmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Walter Reed Visual Assessment Scale) and quality of life (Scoliosis Research Society - 22 Questionnaire) measured at baseline and after intervention period. Results were analyzed using the paired sample t-test to compare repeated measurements and independent sample t-test to compare the groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients included in the current study were consecutive adolescents with idiopathic scoliosis seen in our department who were referred to receive both brace and exercise treatment conservatively. Additional inclusion criteria included the following: female gender; at least age 12 years; primary curve magnitude between 20 and 45 degrees of Cobb angle; double curve (right thoracic-left lumbar) or single thoracolumbar curve having an apex in the main thoracic region; Risser 2-3 and no previous treatment.

Exclusion criteria

  • Exclusion criteria for both groups were as follows: evidence of congenital curve; neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases or surgical correction history.

Treatment and study plan

SEAS exercise

Other

Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The SEAS group received SEAS exercises one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period

CS exercise

Other

Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The CS group received core stabilization exercise training one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period

Primary outcomes

  1. Change in Cobb angle

    Time frame: Change from baseline Cobb angle at 4 months

    Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph

Secondary outcomes

  1. Chance in Posterior trunk symmetry index

    Time frame: Change from baseline trunk symmetry at 4 months

    Posterior trunk symmetry index includes the sensitive assessment of the frontal plane asymmetry of trunk deformity as a two-dimensional surface topographic method in scoliosis. The index based on assessing trunk asymmetry with regard to C7 plumb line, shoulder and hip asymmetry based on back surface photograph of patient.

  2. Change in Walter reed visual assessment scale

    Time frame: Change from baseline cosmetic trunk deformity at 4 months

    Walter reed visual assessment scale assesses patient's cosmetic trunk deformity with set of figures representing seven visible aspects of spinal deformity: Item 1, spinal deformity; item 2, rib prominence; item 3, lumbar prominence; item 4, thoracic deformity; item 5, trunk imbalance; item 6, shoulder asymmetry; and item 7, scapular asymmetry

  3. Change in Scoliosis Research Society 22 Questionnaire

    Time frame: Change from baseline quality of life at 4 months

    Scoliosis Research Society 22 Questionnaire is widely used to evaluate the efficacy of several treatment regimens for idiopathic scoliosis from the patient's perception of his or her condition. The questionnaire consists of 22 items exploring 5 domains related to psychophysical wellbeing: function/activity level, pain, mental health, self-image and treatment satisfaction.

  4. Change in Angle of trunk rotation

    Time frame: Change from baseline angle of trunk rotation at 4 months

    Angle of Trunk rotation is assessed with scoliometer in forward bending test

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Core Stabilization Exercise Versus Scientific Exercises Approach to Scoliosis in the Treatment of Adolescent Idiopathic Scoliosis: A Randomized Single Blind Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2016
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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