<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/NCT03241160</url>
  </required_header>
  <id_info>
    <org_study_id>HACETTEPE</org_study_id>
    <nct_id>NCT03241160</nct_id>
  </id_info>
  <brief_title>Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy</brief_title>
  <official_title>The Severity of Chewing Disorders is Related to Gross Motor Function and Trunk Control in Cerebral Palsy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is planned to determine the relationship between chewing performance level and&#xD;
      gross motor function, and trunk postural control in cerebral palsy (CP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is planned to determine the relationship between chewing performance level and&#xD;
      gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance&#xD;
      level will be determined by the chewing performance scale. The Gross Motor Function&#xD;
      Classification System (GMFCS) will be used to determine gross motor function levels.&#xD;
      Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The&#xD;
      correlations between chewing performance level and gross motor function, and trunk postural&#xD;
      control will be assessed. The Chi-square test will also be used to compare GMFCS levels and&#xD;
      trunk control in children with and without chewing disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2017</start_date>
  <completion_date type="Actual">September 8, 2017</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chewing evaluation</measure>
    <time_frame>15 days</time_frame>
    <description>Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gross motor function evaluation</measure>
    <time_frame>15 days</time_frame>
    <description>Gross motor function evaluation will be performed according to the Gross Motor Function Classification System.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trunk control evaluation</measure>
    <time_frame>15 days</time_frame>
    <description>Segmental Assessment of Trunk Control (SATCo) will be performed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">119</enrollment>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
    <description>Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chewing evaluation</intervention_name>
    <description>Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.</description>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with a diagnosis of spastic cerebral palsy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a diagnosis of cerebral palsy&#xD;
&#xD;
          -  Referring by a pediatric neurologist&#xD;
&#xD;
          -  Aging between 2 to 12 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aging under the age of 24 months&#xD;
&#xD;
          -  Using any medicine and/or oral appliances that could affect the chewing performance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hacetttepe University</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>SELEN SEREL ARSLAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</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/NCT03241160
org study id: HACETTEPE
nct id: NCT03241160
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is planned to determine the relationship between chewing performance level and
      gross motor function, and trunk postural control in cerebral palsy (CP).
The study is planned to determine the relationship between chewing performance level and
      gross motor function, and trunk postural control in cerebral palsy (CP). Chewing performance
      level will be determined by the chewing performance scale. The Gross Motor Function
      Classification System (GMFCS) will be used to determine gross motor function levels.
      Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control. The
      correlations between chewing performance level and gross motor function, and trunk postural
      control will be assessed. The Chi-square test will also be used to compare GMFCS levels and
      trunk control in children with and without chewing disorders.
observational model: Cohort
time perspective: Prospective
measure: Chewing evaluation
time frame: 15 days
description: Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
measure: Gross motor function evaluation
time frame: 15 days
description: Gross motor function evaluation will be performed according to the Gross Motor Function Classification System.
measure: Trunk control evaluation
time frame: 15 days
description: Segmental Assessment of Trunk Control (SATCo) will be performed.
arm group label: Children with cerebral palsy
description: Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included. Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded. Chewing evaluation will be performed.
intervention type: Other
intervention name: Chewing evaluation
description: Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
arm group label: Children with cerebral palsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
last name: SELEN SEREL ARSLAN
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: SELEN SEREL ARSLAN
investigator title: Principal Investigator
mesh term: Cerebral Palsy
sharing ipd: No