<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/NCT03823053</url>
  </required_header>
  <id_info>
    <org_study_id>BVUsyildirim01</org_study_id>
    <nct_id>NCT03823053</nct_id>
  </id_info>
  <brief_title>The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis</brief_title>
  <official_title>The Effect of Core Stabilization Training on Respiratory Parameters, Peripheral Muscle Strength, Balance, Functional Capacity and Quality of Life in Children With Adolescent Idiopathic Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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 vertebral column is a structure that transfers the weight of the head and torso to the&#xD;
      lower extremity, provides trunk movements and protects the spinal cord.A three dimensional&#xD;
      deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above,&#xD;
      including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal&#xD;
      plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic&#xD;
      scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the&#xD;
      closure of growth plates.&#xD;
&#xD;
      Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of&#xD;
      impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ&#xD;
      disorders and pain. In addition, the quality of life in these individuals is also seen to&#xD;
      decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function&#xD;
      and a decrease in functional capacity. At the same time, these children show muscle weakness&#xD;
      in certain parts of the body.&#xD;
&#xD;
      The aim of this study was to investigate the relationship between home based core&#xD;
      stabilization training, respiratory parameters, peripheral muscle strength, balance,&#xD;
      functional capacity and quality of life in individuals with young scoliosis. The&#xD;
      investigators suggest that the addition of core stabilization training to children with mild&#xD;
      and moderate adolescent idiopathic scoliosis will produce good results.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Forced Vital Capacity (FVC) at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Peripheral Muscle strength at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Balance at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline distance covered in Six- Minute Walk Test at 8 weeks</measure>
    <time_frame>Eight weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline axial trunk rotation (ATR)</measure>
    <time_frame>Eight weeks</time_frame>
    <description>Measurements will be applied with Bunnell Scoliometer by physiotherapist.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the &quot;local system&quot; muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the &quot;global system&quot; includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Based Traditional Scoliosis Exercise</intervention_name>
    <description>Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Training Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Based Core Stabilization Training</intervention_name>
    <description>Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.</description>
    <arm_group_label>Training Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adolescent Idiopathic Scoliosis diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental&#xD;
             disorders which may affect the assessments results.&#xD;
&#xD;
          -  Subjects previously undertaken any of spinal surgeries.&#xD;
&#xD;
          -  Subjects involved in exercise training 3 or more days a week.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bezmialem Vakıf University</name>
      <address>
        <city>Istanbul</city>
        <state>Eyüp</state>
        <zip>34050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent idiopathic scoliosis</keyword>
  <keyword>Scoliosis</keyword>
  <keyword>Core Stabilization Training</keyword>
  <keyword>Exercise Training</keyword>
  <keyword>Pulmonary Function Test</keyword>
  <keyword>6 - Minute Walk Test</keyword>
  <keyword>Peripheral Muscle Strength</keyword>
  <keyword>Balance with Biodex</keyword>
  <keyword>Quality of Life</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/NCT03823053
org study id: BVUsyildirim01
nct id: NCT03823053
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The vertebral column is a structure that transfers the weight of the head and torso to the
      lower extremity, provides trunk movements and protects the spinal cord.A three dimensional
      deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above,
      including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal
      plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic
      scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the
      closure of growth plates.

      Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of
      impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ
      disorders and pain. In addition, the quality of life in these individuals is also seen to
      decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function
      and a decrease in functional capacity. At the same time, these children show muscle weakness
      in certain parts of the body.

      The aim of this study was to investigate the relationship between home based core
      stabilization training, respiratory parameters, peripheral muscle strength, balance,
      functional capacity and quality of life in individuals with young scoliosis. The
      investigators suggest that the addition of core stabilization training to children with mild
      and moderate adolescent idiopathic scoliosis will produce good results.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
time frame: Eight weeks
measure: Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks
time frame: Eight weeks
measure: Change from baseline Peripheral Muscle strength at 8 weeks
time frame: Eight weeks
measure: Change from baseline Balance at 8 weeks
time frame: Eight weeks
measure: Change from baseline distance covered in Six- Minute Walk Test at 8 weeks
time frame: Eight weeks
measure: Change from baseline axial trunk rotation (ATR)
time frame: Eight weeks
description: Measurements will be applied with Bunnell Scoliometer by physiotherapist.
arm group label: Control Group
arm group type: Active Comparator
description: The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed.
arm group label: Training Group
arm group type: Experimental
description: In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi.
intervention type: Other
intervention name: Home Based Traditional Scoliosis Exercise
description: Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.
arm group label: Control Group
arm group label: Training Group
intervention type: Other
intervention name: Home Based Core Stabilization Training
description: Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.
arm group label: Training Group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 24 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Scoliosis
sharing ipd: Undecided