<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02978820</url>
  </required_header>
  <id_info>
    <org_study_id>GO 16/82</org_study_id>
    <nct_id>NCT02978820</nct_id>
  </id_info>
  <brief_title>The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis</brief_title>
  <official_title>Core Stabilization Exercise Versus Scientific Exercises Approach to Scoliosis in the Treatment of Adolescent Idiopathic Scoliosis: A Randomized Single Blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Scoliosis specific exercises have been shown to improve curve progression but there have been&#xD;
      few studies that compare the different exercise approaches in adolescent idiopathic scoliosis&#xD;
      (AIS). The objective of this study was to compare the effects of Core stabilization (CS)&#xD;
      exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to&#xD;
      brace wearing in patients with AIS. It is important to compare different exercise methods on&#xD;
      different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation,&#xD;
      body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study was to investigate whether adolescent with idiopathic scoliosis&#xD;
      receiving scoliosis specific exercise approach, such as SEAS exercises, in accordance with&#xD;
      the bracing approach for moderate curves would have greater improvement in curve progression,&#xD;
      trunk deformity, body symmetry and quality of life than adolescent receiving exercise therapy&#xD;
      based on the general core stabilization approach with similar intensity. Thirty female&#xD;
      patients with AIS aged 12 to16 years, who have moderate curves (20 to 45 degree) randomly&#xD;
      divided into two groups. One group received CS exercise, while other received SEAS exercise&#xD;
      for forty-min once weekly for four months. Both groups underwent full-time bracing (23 hours&#xD;
      per day) intervention. Outcome was based on Cobb angle, angle of trunk rotation, body&#xD;
      symmetry (Posterior Trunk Symmetry Index), cosmetic trunk deformity (Walter Reed Visual&#xD;
      Assessment Scale) and quality of life (Scoliosis Research Society - 22 Questionnaire)&#xD;
      measured at baseline and after intervention period. Results were analyzed using the paired&#xD;
      sample t-test to compare repeated measurements and independent sample t-test to compare the&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Cobb angle</measure>
    <time_frame>Change from baseline Cobb angle at 4 months</time_frame>
    <description>Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chance in Posterior trunk symmetry index</measure>
    <time_frame>Change from baseline trunk symmetry at 4 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Walter reed visual assessment scale</measure>
    <time_frame>Change from baseline cosmetic trunk deformity at 4 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Scoliosis Research Society 22 Questionnaire</measure>
    <time_frame>Change from baseline quality of life at 4 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Angle of trunk rotation</measure>
    <time_frame>Change from baseline angle of trunk rotation at 4 months</time_frame>
    <description>Angle of Trunk rotation is assessed with scoliometer in forward bending test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Scoliosis</condition>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>SEAS exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received SEAS exercises in addition to brace wearing for four months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received core stabilization exercise training (CS) in addition to brace wearing for four months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SEAS exercise</intervention_name>
    <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</description>
    <arm_group_label>SEAS exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CS exercise</intervention_name>
    <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</description>
    <arm_group_label>CS exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients included in the current study were consecutive adolescents with&#xD;
             idiopathic scoliosis seen in our department who were referred to receive both brace&#xD;
             and exercise treatment conservatively. Additional inclusion criteria included the&#xD;
             following: female gender; at least age 12 years; primary curve magnitude between 20&#xD;
             and 45 degrees of Cobb angle; double curve (right thoracic-left lumbar) or single&#xD;
             thoracolumbar curve having an apex in the main thoracic region; Risser 2-3 and no&#xD;
             previous treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria for both groups were as follows: evidence of congenital curve;&#xD;
             neuromuscular, rheumatologic, renal, cardiovascular, pulmonary or vestibular diseases&#xD;
             or surgical correction history.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <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.</citation>
    <PMID>22264320</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16759352</PMID>
  </reference>
  <reference>
    <citation>Weinstein SL. Adolescent idiopathic scoliosis: prevalence and natural history. Instr Course Lect. 1989;38:115-28.</citation>
    <PMID>2649564</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18432434</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21198407</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25729406</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27625122</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Gözde Gür</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>scientific exercise approach to scoliosis</keyword>
  <keyword>core stabilization training</keyword>
  <keyword>bracing</keyword>
  <keyword>adolescent idiopathic scoliosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02978820
org study id: GO 16/82
nct id: NCT02978820
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Cobb angle
time frame: Change from baseline Cobb angle at 4 months
description: Cobb angle is considered a gold standard to determine the magnitude of spinal curve on frontal plan radiograph
measure: Chance in Posterior trunk symmetry index
time frame: Change from baseline trunk symmetry at 4 months
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.
measure: Change in Walter reed visual assessment scale
time frame: Change from baseline cosmetic trunk deformity at 4 months
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
measure: Change in Scoliosis Research Society 22 Questionnaire
time frame: Change from baseline quality of life at 4 months
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.
measure: Change in Angle of trunk rotation
time frame: Change from baseline angle of trunk rotation at 4 months
description: Angle of Trunk rotation is assessed with scoliometer in forward bending test
arm group label: SEAS exercise group
arm group type: Experimental
description: This group received SEAS exercises in addition to brace wearing for four months
arm group label: CS exercise group
arm group type: Experimental
description: This group received core stabilization exercise training (CS) in addition to brace wearing for four months
intervention type: Other
intervention name: SEAS exercise
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
arm group label: SEAS exercise group
intervention type: Other
intervention name: CS exercise
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
arm group label: CS exercise group
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
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.
PMID: 22264320
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.
PMID: 16759352
citation: Weinstein SL. Adolescent idiopathic scoliosis: prevalence and natural history. Instr Course Lect. 1989;38:115-28.
PMID: 2649564
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.
PMID: 18432434
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.
PMID: 21198407
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.
PMID: 25729406
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.
PMID: 27625122
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Gözde Gür
investigator title: Research assistant
mesh term: Scoliosis
sharing ipd: Undecided