The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis
Primary Purpose
Scoliosis, Adolescent Idiopathic Scoliosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SEAS exercise
CS exercise
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring scientific exercise approach to scoliosis, core stabilization training, bracing, adolescent idiopathic scoliosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SEAS exercise group
CS exercise group
Arm Description
This group received SEAS exercises in addition to brace wearing for four months
This group received core stabilization exercise training (CS) in addition to brace wearing for four months
Outcomes
Primary Outcome Measures
Change in Cobb angle
Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph
Secondary Outcome Measures
Chance in Posterior trunk symmetry index
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.
Change in Walter reed visual assessment scale
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
Change in Scoliosis Research Society 22 Questionnaire
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.
Change in Angle of trunk rotation
Angle of Trunk rotation is assessed with scoliometer in forward bending test
Full Information
NCT ID
NCT02978820
First Posted
November 20, 2016
Last Updated
November 28, 2016
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT02978820
Brief Title
The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis
Official Title
Core Stabilization Exercise Versus Scientific Exercises Approach to Scoliosis in the Treatment of Adolescent Idiopathic Scoliosis: A Randomized Single Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Adolescent Idiopathic Scoliosis
Keywords
scientific exercise approach to scoliosis, core stabilization training, bracing, adolescent idiopathic scoliosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEAS exercise group
Arm Type
Experimental
Arm Description
This group received SEAS exercises in addition to brace wearing for four months
Arm Title
CS exercise group
Arm Type
Experimental
Arm Description
This group received core stabilization exercise training (CS) in addition to brace wearing for four months
Intervention Type
Other
Intervention Name(s)
SEAS exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
CS exercise
Intervention Description
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 Outcome Measure Information:
Title
Change in Cobb angle
Description
Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph
Time Frame
Change from baseline Cobb angle at 4 months
Secondary Outcome Measure Information:
Title
Chance in Posterior trunk symmetry index
Description
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.
Time Frame
Change from baseline trunk symmetry at 4 months
Title
Change in Walter reed visual assessment scale
Description
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
Time Frame
Change from baseline cosmetic trunk deformity at 4 months
Title
Change in Scoliosis Research Society 22 Questionnaire
Description
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.
Time Frame
Change from baseline quality of life at 4 months
Title
Change in Angle of trunk rotation
Description
Angle of Trunk rotation is assessed with scoliometer in forward bending test
Time Frame
Change from baseline angle of trunk rotation at 4 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22264320
Citation
Negrini S, Aulisa AG, Aulisa L, Circo AB, de Mauroy JC, Durmala J, Grivas TB, Knott P, Kotwicki T, Maruyama T, Minozzi S, O'Brien JP, Papadopoulos D, Rigo M, Rivard CH, Romano M, Wynne JH, Villagrasa M, Weiss HR, Zaina F. 2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis. 2012 Jan 20;7(1):3. doi: 10.1186/1748-7161-7-3.
Results Reference
background
PubMed Identifier
16759352
Citation
Negrini S, Grivas TB, Kotwicki T, Maruyama T, Rigo M, Weiss HR; Members of the Scientific society On Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). Why do we treat adolescent idiopathic scoliosis? What we want to obtain and to avoid for our patients. SOSORT 2005 Consensus paper. Scoliosis. 2006 Apr 10;1:4. doi: 10.1186/1748-7161-1-4.
Results Reference
background
PubMed Identifier
2649564
Citation
Weinstein SL. Adolescent idiopathic scoliosis: prevalence and natural history. Instr Course Lect. 1989;38:115-28.
Results Reference
background
PubMed Identifier
18432434
Citation
Smania N, Picelli A, Romano M, Negrini S. Neurophysiological basis of rehabilitation of adolescent idiopathic scoliosis. Disabil Rehabil. 2008;30(10):763-71. doi: 10.1080/17483100801921311.
Results Reference
background
PubMed Identifier
21198407
Citation
Fusco C, Zaina F, Atanasio S, Romano M, Negrini A, Negrini S. Physical exercises in the treatment of adolescent idiopathic scoliosis: an updated systematic review. Physiother Theory Pract. 2011 Jan;27(1):80-114. doi: 10.3109/09593985.2010.533342.
Results Reference
background
PubMed Identifier
25729406
Citation
Romano M, Negrini A, Parzini S, Tavernaro M, Zaina F, Donzelli S, Negrini S. SEAS (Scientific Exercises Approach to Scoliosis): a modern and effective evidence based approach to physiotherapic specific scoliosis exercises. Scoliosis. 2015 Feb 5;10:3. doi: 10.1186/s13013-014-0027-2. eCollection 2015.
Results Reference
background
PubMed Identifier
27625122
Citation
Gur G, Ayhan C, Yakut Y. The effectiveness of core stabilization exercise in adolescent idiopathic scoliosis: A randomized controlled trial. Prosthet Orthot Int. 2017 Jun;41(3):303-310. doi: 10.1177/0309364616664151. Epub 2016 Sep 13.
Results Reference
background
Learn more about this trial
The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis
We'll reach out to this number within 24 hrs