xml: <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/NCT06021314</url>
    </required_header>
    <id_info>
      <org_study_id>2022-374</org_study_id>
      <nct_id>NCT06021314</nct_id>
    </id_info>
    <brief_title>Brace Efficiency and Generalized Joint Hypermobility</brief_title>
    <official_title>Investigation of the Relationship Between Generalized Joint Hypermobility and Brace Efficiency in Adolescent Idiopathic Scoliosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baskent University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universtiy of Health Sciences - Gülhane Faculty of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Baskent University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about effect of generalised joint&#xD;
        hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis&#xD;
        and who use braces due to brace indication.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does Generalized Joint Hypermobility have an effect on the amount of in-brace&#xD;
             improvement achieved in children using braces?&#xD;
  &#xD;
          -  Does Generalized Joint Hypermobility have an effect on the change in the numerical&#xD;
             variables related to scoliosis recorded in the out-brace measurement at the end of 6&#xD;
             months?&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change of in-brace scoliosis angle</measure>
      <time_frame>Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use</time_frame>
      <description>&quot;Cobb angle&quot; will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated.&#xD;
  In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Generalised Joint Hypermobility</measure>
      <time_frame>After participant being included in the study, latest at the 4th week of the brace use.</time_frame>
      <description>A nine-degree &quot;Beighton scale&quot; will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of in-brace vertebral rotation</measure>
      <time_frame>Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use</time_frame>
      <description>The evaluation of vertebral rotation on radiographs will be made using the Raimondi method regolo (Marrapese Editore-Demi S.r.1., Rome). In roimondi method; through the offset shadow, the widths of the vertebral body are measured in millimeters. The width of each vertebra is determined on the anterior-posterior X-ray at the most narrow spot, the so called vertebral waist. The convex-sided pedicle is marked and bisected longitudinally by a line. In order to determine the pedicle offset, the distance of this bisecting line to the convexsided waist of the vertebral body is evaluated. The value of vertebral rotation is obtained by inserting the width and the pedicle offset in the Raimondi method regolo. The difference between the two measurements will be recorded as in-brace improvement at scoliosis angle.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of in-brace spinal height</measure>
      <time_frame>Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use</time_frame>
      <description>The distance between T1-S1 vertebral bodies in the x-ray image will be recorded in mm to determine the spinal height. The difference between the two measurements will be recorded as change of in-brace spinal height.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of in-brace global cronal balance</measure>
      <time_frame>Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use</time_frame>
      <description>The distance between T the midpoint of the C7 vertebra and the central sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace global cronal balance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of in-brace apical translation</measure>
      <time_frame>Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use</time_frame>
      <description>The distance between the center of apical vertebra in the major curve and the sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace apical translation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brace compliance</measure>
      <time_frame>in-brace condition at the 4th week of the brace use</time_frame>
      <description>Daily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Scoliosis Idiopathic</condition>
    <condition>Hypermobility, Joint</condition>
    <arm_group>
      <arm_group_label>Adolescent Idiopathic Scoliosis</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Brace</intervention_name>
      <description>Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis</description>
      <arm_group_label>Adolescent Idiopathic Scoliosis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants who were diagnosed with adolescent idiopathic scoliosis and planned to use a&#xD;
          cheneau type scoliosis brace.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being under brace treatment due to the diagnosis of adolescent idiopathic scoliosis.&#xD;
  &#xD;
            -  Having a standing posterior-anterior radiograph before and during the brace use.&#xD;
  &#xD;
            -  Having a curve of 20 degree and above according to the Cobb angle.&#xD;
  &#xD;
            -  Confirmation of participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Having systemic diseases related to GJH (Ehlers-Danlos, Down, Marfan, Larsen).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Senay Cerezci Duygu</last_name>
      <phone>+905369128768</phone>
      <email>senaycerezci@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Senay Cerezci Duygu</name>
        <address>
          <city>Ankara</city>
          <state>Keçiören</state>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Senay Cerezci Duygu</last_name>
        <phone>05369128768</phone>
        <email>senaycerezci@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>Senay Cerezci Duygu</investigator_full_name>
      <investigator_title>Asst. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Scoliosis</mesh_term>
      <mesh_term>Joint Instability</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021314
  org study id: 2022-374
  nct id: NCT06021314
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about effect of generalised joint
        hypermobility on the effectiveness of the brace in children with Adolesan Idiopatic Scoliosis
        and who use braces due to brace indication.
  
        The main questions it aims to answer are:
  
          -  Does Generalized Joint Hypermobility have an effect on the amount of in-brace
             improvement achieved in children using braces?
  
          -  Does Generalized Joint Hypermobility have an effect on the change in the numerical
             variables related to scoliosis recorded in the out-brace measurement at the end of 6
             months?
  observational model: Other
  time perspective: Prospective
  measure: Change of in-brace scoliosis angle
  time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
  description: "Cobb angle" will be taken as reference to determine the scoliosis angle. For Cobb angle measurement, the angle between the upper border of the upper vertebra and the lower border of the lowest vertebra will be calculated.
  In order to determine change of scoliosis angle with brace use, the x-ray image taken just before starting to use the brace and the x-ray image taken while the brace is on the participant (in-brace condition) at the 4th week of brace usage will be evaluated. The difference between the two measurements will be recorded as change of in-brace scoliosis angle.
  measure: Generalised Joint Hypermobility
  time frame: After participant being included in the study, latest at the 4th week of the brace use.
  description: A nine-degree "Beighton scale" will be used to determine the occurrence of generalized joint hypermobility. Additionally, a five-part questionnaire by Hakim and Graham will be used. Obtaining 4 or more points on Beighton scale and simultaneously at least 2 points in the ques-tionnaire by Hakim and Graham will be adopted as a criterion for generalized joint hypermobility diagnosis.
  measure: Change of in-brace vertebral rotation
  time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
  description: The evaluation of vertebral rotation on radiographs will be made using the Raimondi method regolo (Marrapese Editore-Demi S.r.1., Rome). In roimondi method; through the offset shadow, the widths of the vertebral body are measured in millimeters. The width of each vertebra is determined on the anterior-posterior X-ray at the most narrow spot, the so called vertebral waist. The convex-sided pedicle is marked and bisected longitudinally by a line. In order to determine the pedicle offset, the distance of this bisecting line to the convexsided waist of the vertebral body is evaluated. The value of vertebral rotation is obtained by inserting the width and the pedicle offset in the Raimondi method regolo. The difference between the two measurements will be recorded as in-brace improvement at scoliosis angle.
  measure: Change of in-brace spinal height
  time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
  description: The distance between T1-S1 vertebral bodies in the x-ray image will be recorded in mm to determine the spinal height. The difference between the two measurements will be recorded as change of in-brace spinal height.
  measure: Change of in-brace global cronal balance
  time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
  description: The distance between T the midpoint of the C7 vertebra and the central sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace global cronal balance.
  measure: Change of in-brace apical translation
  time frame: Measurement-1: Just before starting the brace use (Retrospectively)/ Measurement-2: In-brace condition at the 4th week of the brace use
  description: The distance between the center of apical vertebra in the major curve and the sacral vertical line (CSVL) in the x-ray image will be recorded in mm to determine the global cronal balance of spine. The difference between the two measurements will be recorded as change of in-brace apical translation.
  measure: Brace compliance
  time frame: in-brace condition at the 4th week of the brace use
  description: Daily usage hours and total brace usage time will be questioned retrospectively at the 4th week of brace use.
  arm group label: Adolescent Idiopathic Scoliosis
  intervention type: Other
  intervention name: Brace
  description: Cheneau type scoliosis brace due to brace indication for adolecant idiopatic scoliosis
  arm group label: Adolescent Idiopathic Scoliosis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Senay Cerezci Duygu
  phone: +905369128768
  email: senaycerezci@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: Senay Cerezci Duygu
  investigator title: Asst. Prof.
  mesh term: Scoliosis
  mesh term: Joint Instability
  sharing ipd: No