<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/NCT04421157</url>
  </required_header>
  <id_info>
    <org_study_id>KaramanogluMehmetbeyU</org_study_id>
    <nct_id>NCT04421157</nct_id>
  </id_info>
  <brief_title>Exercises in Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>The Effectiveness of Two Different Exercises in Adolescent Idiopathic Scoliosis: A Single-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karamanoğlu Mehmetbey University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karamanoğlu Mehmetbey University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the effectiveness of two different exercises in&#xD;
      adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis&#xD;
      were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The&#xD;
      Schroth group received Schroth exercises in addition to traditional rehabilitation, and the&#xD;
      stabilization group received core stabilization in addition to traditional rehabilitation for&#xD;
      10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal&#xD;
      mobility, cosmetic trunk deformity, muscle strength, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology,&#xD;
      characterized by a three-dimensional deformity of the spine (frontal translation, sagittal&#xD;
      modification, and torsion of the spinous processes on the concave side of the scoliotic curve&#xD;
      on radiographs).&#xD;
&#xD;
      In patients with AIS, in addition to curve progression there are many problems commonly occur&#xD;
      such as; muscular imbalance, functional limitations, altered posture, gait deviations,&#xD;
      reduced flexibility of the spine, back pain, negative physico-social, body image effects, and&#xD;
      in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected&#xD;
      related to the shape and angle of scoliosis, and the weight distribution position changes&#xD;
      depending on the shape and the Cobb angle of scoliosis. To deal with these complications and&#xD;
      more, various treatment approaches have been proposed for AIS, including exercise, bracing,&#xD;
      casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt&#xD;
      the progression of the deformity. Conservative treatment methods including physiotherapy and&#xD;
      bracing are accepted in Central Europe.&#xD;
&#xD;
      In literature, exercises are recommended to decrease progression, to improve spine and&#xD;
      thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior,&#xD;
      and neuro-motor control, spine stability. In general, traditional exercises (TE) including&#xD;
      postural training, stretching, and strengthening exercises for spinal musculature,&#xD;
      respiratory exercises have been used for many years for scoliosis. Except for the traditional&#xD;
      exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed&#xD;
      methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that&#xD;
      aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target&#xD;
      strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim&#xD;
      of Schroth exercises is to improve motor control of the posture by repeating corrective&#xD;
      movements with progressively less feedback. Schroth exercises are the most studied scoliosis&#xD;
      exercises but there are limited randomized controlled studies on Schroth exercises.&#xD;
&#xD;
      Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises,&#xD;
      Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises&#xD;
      are described as therapy techniques that improve postural control, and functional stability&#xD;
      through increasing neuromuscular control, the strength of trunk stabilization muscles, the&#xD;
      endurance of postural muscles around the spine, the balance between pelvis and spine.&#xD;
      However, limited studies are determining CS exercises' effect on patients with AIS. In a&#xD;
      study CS exercises found to be more effective in reducing pain and rotational deformity than&#xD;
      traditional exercises in the conservative rehabilitation of AIS.&#xD;
&#xD;
      A recent systematic review showed that therapeutic exercise had been effective to reduce&#xD;
      symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to&#xD;
      improve muscular endurance, pulmonary function, and functional capacity of patients with AIS.&#xD;
      Corrective, therapeutic exercises appear to have positive effects by improving function and&#xD;
      reducing symptoms, as well as various angles and body asymmetries. However, further studies&#xD;
      with better methodological quality are required to confirm these outcomes and detect the best&#xD;
      therapeutic exercise intervention. And also there is a need for randomized controlled studies&#xD;
      on different methods of exercise to choose the most effective exercise in clinical practice.&#xD;
&#xD;
      There was no research compared to the effects of the Schroth method and CS exercises in&#xD;
      patients with AIS. And also there was no research examining the effects of the Schroth method&#xD;
      on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth&#xD;
      versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation,&#xD;
      peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality&#xD;
      of life in patients with AIS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 17, 2019</start_date>
  <completion_date type="Actual">March 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 28, 2020</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>
    <intervention_model_description>Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessments were undertaken at baseline, and after the 10 week treatment period for each patient by the investigator, who was blind to the allocation of the participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cobb's angle</measure>
    <time_frame>10 week</time_frame>
    <description>Cobb's angles were measured on standard standing anterior-posterior spine radiograph and recorded as degrees. Cobb angle is considered the gold standard to evaluate the curve magnitude. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Trunk rotation angles</measure>
    <time_frame>10 week</time_frame>
    <description>-Trunk rotation angles Axial trunk rotations (ATR) were assessed with a scoliometer in Adam's forward bend test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>10 week</time_frame>
    <description>Muscle strengths were assessed by a Biodex System 4-Pro dynamometer (Biodex, Inc., Shirley, New York). Upper extremity pattern strengths (flexion-abduction-external rotation / extension-adduction-internal rotation), and quadriceps, hamstring muscles strengths were assessed in both extremity. The outcome parameter was the peak torque (expressed in Nm) which was normalized to the participants' body weight (expressed in Nm/kg) in an effort to reduce inter-subject variability in raw scores of quantitative muscle tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spinal mobility</measure>
    <time_frame>10 week</time_frame>
    <description>Spinal mobility was assessed with a new computer-aided skin-surface device (The Spinal Mouse® System, Idiag, Fehraltorf, Switzerland). Spinal Mouse is an external non-invasive measurement method developed to evaluate the motility and shape of the spine in many planes. The Spinal Mouse has acceptable metrological properties to assess segmental and global thoracal and lumbar mobility. Measurements were performed between spinous process of C7 and the top of the anal crease (approximately S3). Maximal extension, maximal flexion and maximal left and right lateral flexion positions were performed. The analysis of spinal mobility in the sagittal (SAP - maximal extension to flexion) and the coronal (CRP - maximal left to right flexion) plane was evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic trunk deformity</measure>
    <time_frame>10 week</time_frame>
    <description>Walter Reed Visual Assessment Scale (WRVAS) was used to assess cosmetic deformity. The domains of WRVAS are body curve, rib prominence, flank prominence, head rib pelvis, head pelvis, shoulder level, and scapular rotation. Each domain generates a score from 1 (best deformity) to 5 (worst deformity). The total score is an average of these 7 domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SRS-22 Questionnaire</measure>
    <time_frame>10 week</time_frame>
    <description>The SRS-22 questionnaire assesses the quality of life in scoliosis. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions which are scored from 1 (best answer) to 5 (worst answer) each question. A total score is based on all 22 questions and an average of these 7 domains.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Schroth group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Schroth group received Schroth exercises in addition to traditional rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stabilization group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The stabilization group received core stabilization in addition to traditional rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Schroth Exercises</intervention_name>
    <description>The Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.</description>
    <arm_group_label>Schroth group</arm_group_label>
    <other_name>Schroth Method</other_name>
    <other_name>Scoliosis specific exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core stabilization Exercises</intervention_name>
    <description>Each exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.</description>
    <arm_group_label>Stabilization group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a diagnosis of adolescent idiopathic scoliosis,&#xD;
&#xD;
          -  A Cobb angle of 10 to 30 degrees&#xD;
&#xD;
          -  Having Lenke type 1 curve&#xD;
&#xD;
          -  No other treatment which might affect scoliosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-idiopathic scoliosis&#xD;
&#xD;
          -  Prescribed brace&#xD;
&#xD;
          -  Surgical correction history&#xD;
&#xD;
          -  Who were unable to participate in the supervised sessions,or those who refused to&#xD;
             follow treatment were excluded.&#xD;
&#xD;
          -  Contraindications to exercise -Accompanying mental problems, neurological- muscular or&#xD;
             rheumatic diseases,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hikmet Kocaman, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karamanoğlu Mehmetbey University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karamanoglu Mehmetbey University</name>
      <address>
        <city>Karaman</city>
        <zip>70200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Romano M, Minozzi S, Zaina F, Saltikov JB, Chockalingam N, Kotwicki T, Hennes AM, Negrini S. Exercises for adolescent idiopathic scoliosis: a Cochrane systematic review. Spine (Phila Pa 1976). 2013 Jun 15;38(14):E883-93. doi: 10.1097/BRS.0b013e31829459f8.</citation>
    <PMID>23558442</PMID>
  </reference>
  <reference>
    <citation>Shneerson JM, Madgwick R. The effect of physical training on exercise ability in adolescent idiopathic scoliosis. Acta Orthop Scand. 1979 Jun;50(3):303-6. doi: 10.3109/17453677908989771.</citation>
    <PMID>474101</PMID>
  </reference>
  <reference>
    <citation>Negrini S, Fusco C, Minozzi S, Atanasio S, Zaina F, Romano M. Exercises reduce the progression rate of adolescent idiopathic scoliosis: results of a comprehensive systematic review of the literature. Disabil Rehabil. 2008;30(10):772-85. doi: 10.1080/09638280801889568.</citation>
    <PMID>18432435</PMID>
  </reference>
  <reference>
    <citation>Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.</citation>
    <PMID>28033399</PMID>
  </reference>
  <reference>
    <citation>Schreiber S, Parent EC, Hill DL, Hedden DM, Moreau MJ, Southon SC. Patients with adolescent idiopathic scoliosis perceive positive improvements regardless of change in the Cobb angle - Results from a randomized controlled trial comparing a 6-month Schroth intervention added to standard care and standard care alone. SOSORT 2018 Award winner. BMC Musculoskelet Disord. 2019 Jul 8;20(1):319. doi: 10.1186/s12891-019-2695-9.</citation>
    <PMID>31286903</PMID>
  </reference>
  <reference>
    <citation>Thompson JY, Williamson EM, Williams MA, Heine PJ, Lamb SE; ACTIvATeS Study Group. Effectiveness of scoliosis-specific exercises for adolescent idiopathic scoliosis compared with other non-surgical interventions: a systematic review and meta-analysis. Physiotherapy. 2019 Jun;105(2):214-234. doi: 10.1016/j.physio.2018.10.004. Epub 2018 Oct 27.</citation>
    <PMID>30824243</PMID>
  </reference>
  <reference>
    <citation>Ceballos Laita L, Tejedor Cubillo C, Mingo Gomez T, Jimenez Del Barrio S. Effects of corrective, therapeutic exercise techniques on adolescent idiopathic scoliosis. A systematic review. Arch Argent Pediatr. 2018 Aug 1;116(4):e582-e589. doi: 10.5546/aap.2018.eng.e582. English, Spanish.</citation>
    <PMID>30016036</PMID>
  </reference>
  <reference>
    <citation>Kim G, HwangBo PN. Effects of Schroth and Pilates exercises on the Cobb angle and weight distribution of patients with scoliosis. J Phys Ther Sci. 2016 Mar;28(3):1012-5. doi: 10.1589/jpts.28.1012. Epub 2016 Mar 31.</citation>
    <PMID>27134403</PMID>
  </reference>
  <reference>
    <citation>Nault ML, Allard P, Hinse S, Le Blanc R, Caron O, Labelle H, Sadeghi H. Relations between standing stability and body posture parameters in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1911-7. doi: 10.1097/00007632-200209010-00018.</citation>
    <PMID>12221357</PMID>
  </reference>
  <reference>
    <citation>Sanders JO, Polly DW Jr, Cats-Baril W, Jones J, Lenke LG, O'Brien MF, Stephens Richards B, Sucato DJ; AIS Section of the Spinal Deformity Study Group. Analysis of patient and parent assessment of deformity in idiopathic scoliosis using the Walter Reed Visual Assessment Scale. Spine (Phila Pa 1976). 2003 Sep 15;28(18):2158-63. doi: 10.1097/01.BRS.0000084629.97042.0B.</citation>
    <PMID>14501929</PMID>
  </reference>
  <reference>
    <citation>Coelho DM, Bonagamba GH, Oliveira AS. Scoliometer measurements of patients with idiopathic scoliosis. Braz J Phys Ther. 2013 Mar-Apr;17(2):179-84. doi: 10.1590/S1413-35552012005000081.</citation>
    <PMID>23778766</PMID>
  </reference>
  <reference>
    <citation>Alves de Araujo ME, Bezerra da Silva E, Bragade Mello D, Cader SA, Shiguemi Inoue Salgado A, Dantas EH. The effectiveness of the Pilates method: reducing the degree of non-structural scoliosis, and improving flexibility and pain in female college students. J Bodyw Mov Ther. 2012 Apr;16(2):191-8. doi: 10.1016/j.jbmt.2011.04.002. Epub 2012 Jan 5.</citation>
    <PMID>22464116</PMID>
  </reference>
  <reference>
    <citation>Martinez-Llorens J, Ramirez M, Colomina MJ, Bago J, Molina A, Caceres E, Gea J. Muscle dysfunction and exercise limitation in adolescent idiopathic scoliosis. Eur Respir J. 2010 Aug;36(2):393-400. doi: 10.1183/09031936.00025509. Epub 2009 Dec 23.</citation>
    <PMID>20032022</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>
  <reference>
    <citation>Ameer MA, Kamel MI, Elhafez YM. A comparison of sagittal spine deformities among elementary school students using spinal mouse device. Work. 2019;64(3):545-550. doi: 10.3233/WOR-193015.</citation>
    <PMID>31658087</PMID>
  </reference>
  <reference>
    <citation>Livanelioglu A, Kaya F, Nabiyev V, Demirkiran G, Firat T. The validity and reliability of &quot;Spinal Mouse&quot; assessment of spinal curvatures in the frontal plane in pediatric adolescent idiopathic thoraco-lumbar curves. Eur Spine J. 2016 Feb;25(2):476-82. doi: 10.1007/s00586-015-3945-7. Epub 2015 Apr 22.</citation>
    <PMID>25900295</PMID>
  </reference>
  <reference>
    <citation>Cheshire J, Gardner A, Berryman F, Pynsent P. Do the SRS-22 self-image and mental health domain scores reflect the degree of asymmetry of the back in adolescent idiopathic scoliosis? Scoliosis Spinal Disord. 2017 Dec 11;12:37. doi: 10.1186/s13013-017-0144-9. eCollection 2017.</citation>
    <PMID>29238754</PMID>
  </reference>
  <reference>
    <citation>Tsai YT, Leong CP, Huang YC, Kuo SH, Wang HC, Yeh HC, Lau YC. The electromyographic responses of paraspinal muscles during isokinetic exercise in adolescents with idiopathic scoliosis with a Cobb's angle less than fifty degrees. Chang Gung Med J. 2010 Sep-Oct;33(5):540-50.</citation>
    <PMID>20979705</PMID>
  </reference>
  <reference>
    <citation>Lin JJ, Chen WH, Chen PQ, Tsauo JY. Alteration in shoulder kinematics and associated muscle activity in people with idiopathic scoliosis. Spine (Phila Pa 1976). 2010 May 15;35(11):1151-7. doi: 10.1097/BRS.0b013e3181cd5923.</citation>
    <PMID>20421854</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karamanoğlu Mehmetbey University</investigator_affiliation>
    <investigator_full_name>Hikmet Kocaman</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Adolescent Idiopathic Scoliosis, Scoliosis, Exercise</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>No</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/NCT04421157
org study id: KaramanogluMehmetbeyU
nct id: NCT04421157
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to investigate the effectiveness of two different exercises in
      adolescent idiopathic scoliosis. In total, 28 subjects with adolescent idiopathic scoliosis
      were randomly divided into two groups: Schroth (n = 14) and stabilization group (n = 14). The
      Schroth group received Schroth exercises in addition to traditional rehabilitation, and the
      stabilization group received core stabilization in addition to traditional rehabilitation for
      10 weeks. The outcome measures were based on Cobb angle, angle of trunk rotation, spinal
      mobility, cosmetic trunk deformity, muscle strength, and quality of life.
Adolescent idiopathic scoliosis (AIS) is a progressive growth disease with unknown etiology,
      characterized by a three-dimensional deformity of the spine (frontal translation, sagittal
      modification, and torsion of the spinous processes on the concave side of the scoliotic curve
      on radiographs).

      In patients with AIS, in addition to curve progression there are many problems commonly occur
      such as; muscular imbalance, functional limitations, altered posture, gait deviations,
      reduced flexibility of the spine, back pain, negative physico-social, body image effects, and
      in severe cases pulmonary symptoms. The asymmetry of the trunk and pelvis are affected
      related to the shape and angle of scoliosis, and the weight distribution position changes
      depending on the shape and the Cobb angle of scoliosis. To deal with these complications and
      more, various treatment approaches have been proposed for AIS, including exercise, bracing,
      casting, traction, biofeedback, surgery, and simple observation to prevent, correct or halt
      the progression of the deformity. Conservative treatment methods including physiotherapy and
      bracing are accepted in Central Europe.

      In literature, exercises are recommended to decrease progression, to improve spine and
      thoracic cage flexibility, muscle strengths, and elasticity, to correct postural behavior,
      and neuro-motor control, spine stability. In general, traditional exercises (TE) including
      postural training, stretching, and strengthening exercises for spinal musculature,
      respiratory exercises have been used for many years for scoliosis. Except for the traditional
      exercises, there are several exercise concepts including Schroth, Side Shift, Dobomed
      methods... etc. Schroth exercises are asymmetric scoliosis-specific postural exercises that
      aim to improve the curve, function, posture, self-image, and pain. Schroth exercises target
      strength and endurance training of the back, abdominal, and leg muscles. Also one of the aim
      of Schroth exercises is to improve motor control of the posture by repeating corrective
      movements with progressively less feedback. Schroth exercises are the most studied scoliosis
      exercises but there are limited randomized controlled studies on Schroth exercises.

      Recently general physiotherapeutic exercises including, Core stabilization (CS) exercises,
      Pilates have been used in the conservative treatment of idiopathic scoliosis. CS exercises
      are described as therapy techniques that improve postural control, and functional stability
      through increasing neuromuscular control, the strength of trunk stabilization muscles, the
      endurance of postural muscles around the spine, the balance between pelvis and spine.
      However, limited studies are determining CS exercises' effect on patients with AIS. In a
      study CS exercises found to be more effective in reducing pain and rotational deformity than
      traditional exercises in the conservative rehabilitation of AIS.

      A recent systematic review showed that therapeutic exercise had been effective to reduce
      symptoms, Cobb's angle, trunk rotation, craniovertebral angle, and body asymmetries, and to
      improve muscular endurance, pulmonary function, and functional capacity of patients with AIS.
      Corrective, therapeutic exercises appear to have positive effects by improving function and
      reducing symptoms, as well as various angles and body asymmetries. However, further studies
      with better methodological quality are required to confirm these outcomes and detect the best
      therapeutic exercise intervention. And also there is a need for randomized controlled studies
      on different methods of exercise to choose the most effective exercise in clinical practice.

      There was no research compared to the effects of the Schroth method and CS exercises in
      patients with AIS. And also there was no research examining the effects of the Schroth method
      on peripheral muscle strengths. This study aimed to investigate the effects of the Schroth
      versus CS exercises in addition to traditional exercises, on Cobb angle, trunk rotation,
      peripheral muscle strengths, spine mobility, cosmetic deformity, and health-related quality
      of life in patients with AIS.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Each patient selected a number in a closed envelope, which was sorted via the 'Research Randomiser' program for the randomisation process, and the patients were separated into the following two groups; Schroth group (n=14) and stabilization group (n=14)
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Assessments were undertaken at baseline, and after the 10 week treatment period for each patient by the investigator, who was blind to the allocation of the participants.
measure: Cobb's angle
time frame: 10 week
description: Cobb's angles were measured on standard standing anterior-posterior spine radiograph and recorded as degrees. Cobb angle is considered the gold standard to evaluate the curve magnitude. The Cobb angle is the angle from a posterior-anterior full spine radiographs between the upper endplate of the upper-end vertebra of the largest curve and the lower endplate of the lower end vertebra from the largest curve.
measure: Trunk rotation angles
time frame: 10 week
description: -Trunk rotation angles Axial trunk rotations (ATR) were assessed with a scoliometer in Adam's forward bend test.
measure: Muscle strength
time frame: 10 week
description: Muscle strengths were assessed by a Biodex System 4-Pro dynamometer (Biodex, Inc., Shirley, New York). Upper extremity pattern strengths (flexion-abduction-external rotation / extension-adduction-internal rotation), and quadriceps, hamstring muscles strengths were assessed in both extremity. The outcome parameter was the peak torque (expressed in Nm) which was normalized to the participants' body weight (expressed in Nm/kg) in an effort to reduce inter-subject variability in raw scores of quantitative muscle tests.
measure: Spinal mobility
time frame: 10 week
description: Spinal mobility was assessed with a new computer-aided skin-surface device (The Spinal Mouse® System, Idiag, Fehraltorf, Switzerland). Spinal Mouse is an external non-invasive measurement method developed to evaluate the motility and shape of the spine in many planes. The Spinal Mouse has acceptable metrological properties to assess segmental and global thoracal and lumbar mobility. Measurements were performed between spinous process of C7 and the top of the anal crease (approximately S3). Maximal extension, maximal flexion and maximal left and right lateral flexion positions were performed. The analysis of spinal mobility in the sagittal (SAP - maximal extension to flexion) and the coronal (CRP - maximal left to right flexion) plane was evaluated.
measure: Cosmetic trunk deformity
time frame: 10 week
description: Walter Reed Visual Assessment Scale (WRVAS) was used to assess cosmetic deformity. The domains of WRVAS are body curve, rib prominence, flank prominence, head rib pelvis, head pelvis, shoulder level, and scapular rotation. Each domain generates a score from 1 (best deformity) to 5 (worst deformity). The total score is an average of these 7 domains.
measure: SRS-22 Questionnaire
time frame: 10 week
description: The SRS-22 questionnaire assesses the quality of life in scoliosis. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions which are scored from 1 (best answer) to 5 (worst answer) each question. A total score is based on all 22 questions and an average of these 7 domains.
arm group label: Schroth group
arm group type: Experimental
description: The Schroth group received Schroth exercises in addition to traditional rehabilitation.
arm group label: Stabilization group
arm group type: Experimental
description: The stabilization group received core stabilization in addition to traditional rehabilitation.
intervention type: Other
intervention name: Schroth Exercises
description: The Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
arm group label: Schroth group
other name: Schroth Method
other name: Scoliosis specific exercises
intervention type: Other
intervention name: Core stabilization Exercises
description: Each exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
arm group label: Stabilization group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Hikmet Kocaman, MSc
role: Principal Investigator
affiliation: Karamanoğlu Mehmetbey University
facility: 
country: Turkey
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PMID: 28033399
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PMID: 31286903
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PMID: 30016036
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PMID: 20421854
responsible party type: Principal Investigator
investigator affiliation: Karamanoğlu Mehmetbey University
investigator full name: Hikmet Kocaman
investigator title: Research Assistant
mesh term: Scoliosis
sharing ipd: No