<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/NCT02984735</url>
  </required_header>
  <id_info>
    <org_study_id>HACETTEPEUNI</org_study_id>
    <nct_id>NCT02984735</nct_id>
  </id_info>
  <brief_title>Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy</brief_title>
  <official_title>Association Between Chewing Performance Level and Gross Motor Function in Children With 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the association between gross motor function and&#xD;
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was&#xD;
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross&#xD;
      Motor Function Classification System (GMFCS) was used to determine gross motor function&#xD;
      levels of children. Chewing performance level was determined by using the Karaduman Chewing&#xD;
      Performance Scale (KCPS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the association between gross motor function and&#xD;
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was&#xD;
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross&#xD;
      Motor Function Classification System (GMFCS) was used to determine gross motor function&#xD;
      levels of children. Chewing performance level was determined by using the Karaduman Chewing&#xD;
      Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were&#xD;
      referred due to chewing/swallowing problems by pediatric neurologists were included. The&#xD;
      inclusion criteria were above the age of 24 months, and had complaints about chewing&#xD;
      function. Children under the age of 24 months, requiring tube feeding or taking any oral&#xD;
      nutritional supplements, and used any medicine and/or oral appliances that could affect the&#xD;
      chewing performance, were excluded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Chewing performance level</measure>
    <time_frame>10 minutes</time_frame>
    <description>Chewing evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gross motor function level</measure>
    <time_frame>10 minutes</time_frame>
    <description>Motor function evaluation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Chewing Problem</condition>
  <condition>Gross Motor Development Delay</condition>
  <arm_group>
    <arm_group_label>Evaluation of children with spastic CP</arm_group_label>
    <description>Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation</intervention_name>
    <description>Descriptive characteristics including age, height and weight were recorded. Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS). Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew. The physical therapist rated the chewing performance according to the KCPS. All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS). In addition to GMFCS, number of affected limbs of the children was also noted.</description>
    <arm_group_label>Evaluation of children with spastic CP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to&#xD;
        chewing/swallowing problems by pediatric neurologists&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above the age of 24 months&#xD;
&#xD;
          -  Having complaints about chewing function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 24 months&#xD;
&#xD;
          -  Requiring tube feeding or taking any oral nutritional supplements&#xD;
&#xD;
          -  Using any medicine and/or oral appliances&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SELEN SEREL ARSLAN, PhD</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>August 2017</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 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>Selen Serel Arslan</investigator_title>
  </responsible_party>
  <keyword>chewing</keyword>
  <keyword>cerebral palsy</keyword>
  <keyword>chewing disorders</keyword>
  <keyword>gross motor function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <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/NCT02984735
org study id: HACETTEPEUNI
nct id: NCT02984735
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the association between gross motor function and
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross
      Motor Function Classification System (GMFCS) was used to determine gross motor function
      levels of children. Chewing performance level was determined by using the Karaduman Chewing
      Performance Scale (KCPS).
The purpose of this study is to determine the association between gross motor function and
      chewing performance level in children with cerebral palsy (CP). A cross-sectional study was
      conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross
      Motor Function Classification System (GMFCS) was used to determine gross motor function
      levels of children. Chewing performance level was determined by using the Karaduman Chewing
      Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were
      referred due to chewing/swallowing problems by pediatric neurologists were included. The
      inclusion criteria were above the age of 24 months, and had complaints about chewing
      function. Children under the age of 24 months, requiring tube feeding or taking any oral
      nutritional supplements, and used any medicine and/or oral appliances that could affect the
      chewing performance, were excluded.
observational model: Cohort
time perspective: Cross-Sectional
measure: Chewing performance level
time frame: 10 minutes
description: Chewing evaluation
measure: Gross motor function level
time frame: 10 minutes
description: Motor function evaluation
arm group label: Evaluation of children with spastic CP
description: Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.
intervention type: Other
intervention name: Evaluation
description: Descriptive characteristics including age, height and weight were recorded. Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS). Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew. The physical therapist rated the chewing performance according to the KCPS. All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS). In addition to GMFCS, number of affected limbs of the children was also noted.
arm group label: Evaluation of children with spastic CP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: SELEN SEREL ARSLAN, PhD
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: Selen Serel Arslan
mesh term: Paralysis
mesh term: Cerebral Palsy
sharing ipd: No