<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/NCT03811353</url>
  </required_header>
  <id_info>
    <org_study_id>ArslanSerel2019</org_study_id>
    <nct_id>NCT03811353</nct_id>
  </id_info>
  <brief_title>The Turkish Mastication Observation and Evaluation (T-MOE) Instrument</brief_title>
  <official_title>Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument</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 purpose of this study is to test the reliability and validity of the T-MOE among&#xD;
      pediatric patients with chewing disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to test the reliability and validity of the T-MOE among&#xD;
      pediatric patients with chewing disorders.The internal consistency, test-retest reliability,&#xD;
      and criterion validity of T-MOE will be investigated. The internal consistency will be&#xD;
      assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 %&#xD;
      confidence intervals will be calculated for test-retest reliability. The criterion validity&#xD;
      of the scale will be determined by assessing the correlation between the T-MOE and Karaduman&#xD;
      Chewing Performance Scale and Tongue Thrust Rating Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">March 19, 2019</completion_date>
  <primary_completion_date type="Actual">March 19, 2019</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>The Turkish Mastication Observation and Evaluation (T-MOE) Instrument</measure>
    <time_frame>3 months</time_frame>
    <description>This instrument is used to evaluate chewing function in children. The T-MOE includes 8 items, and could be scored between 1 to 4. Higher scores indicate better chewing function, lower scores indicate worse chewing function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Karaduman Chewing Performance Scale (KCPS)</measure>
    <time_frame>3 months</time_frame>
    <description>This scale is used to determine chewing performance level of children. The KCPS has 5 steps including 0 to 4. 0 means 'Normal chewing function' and 4 means 'No biting and chewing'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tongue Thrust Rating Scale (TTRS)</measure>
    <time_frame>3 months</time_frame>
    <description>This scale is used to determine tongue thrust severity of children. The TTRS has 4 steps between 0 to 3. Step 0 means 'No tongue thrust.' and step 3 means 'Severe tongue thrust. The tongue is positioned out of the mouth.'</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Chewing Problem</condition>
  <condition>Swallowing Disorder</condition>
  <arm_group>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
    <description>Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy children</arm_group_label>
    <description>Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>T-MOE</intervention_name>
    <description>Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.</description>
    <arm_group_label>Children with cerebral palsy</arm_group_label>
    <arm_group_label>Healthy children</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with serebral palsy and healthy children&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having chewing disorders aged between 18 months-12 years&#xD;
&#xD;
          -  Being serebral palsy&#xD;
&#xD;
          -  Being healthy children&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No chewing disorders&#xD;
&#xD;
          -  A child aged below 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</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>March 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</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>Deglutition Disorders</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/NCT03811353
org study id: ArslanSerel2019
nct id: NCT03811353
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the reliability and validity of the T-MOE among
      pediatric patients with chewing disorders.
The purpose of this study is to test the reliability and validity of the T-MOE among
      pediatric patients with chewing disorders.The internal consistency, test-retest reliability,
      and criterion validity of T-MOE will be investigated. The internal consistency will be
      assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 %
      confidence intervals will be calculated for test-retest reliability. The criterion validity
      of the scale will be determined by assessing the correlation between the T-MOE and Karaduman
      Chewing Performance Scale and Tongue Thrust Rating Scale.
observational model: Cohort
time perspective: Prospective
measure: The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
time frame: 3 months
description: This instrument is used to evaluate chewing function in children. The T-MOE includes 8 items, and could be scored between 1 to 4. Higher scores indicate better chewing function, lower scores indicate worse chewing function.
measure: The Karaduman Chewing Performance Scale (KCPS)
time frame: 3 months
description: This scale is used to determine chewing performance level of children. The KCPS has 5 steps including 0 to 4. 0 means 'Normal chewing function' and 4 means 'No biting and chewing'.
measure: Tongue Thrust Rating Scale (TTRS)
time frame: 3 months
description: This scale is used to determine tongue thrust severity of children. The TTRS has 4 steps between 0 to 3. Step 0 means 'No tongue thrust.' and step 3 means 'Severe tongue thrust. The tongue is positioned out of the mouth.'
arm group label: Children with cerebral palsy
description: Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale.
arm group label: Healthy children
description: Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale.
intervention type: Diagnostic Test
intervention name: T-MOE
description: Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
arm group label: Children with cerebral palsy
arm group label: Healthy children
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Months
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: Deglutition Disorders
sharing ipd: No