<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/NCT04477174</url>
  </required_header>
  <id_info>
    <org_study_id>308</org_study_id>
    <nct_id>NCT04477174</nct_id>
  </id_info>
  <brief_title>Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale</brief_title>
  <official_title>Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</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>
      Purpose of the study is the validity and reliability of the Turkish version of the Yale&#xD;
      Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an&#xD;
      assessment tool for dysphagia patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The swallow function is a multidirectional process that depends on complex neuro-muscular&#xD;
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic&#xD;
      evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many&#xD;
      questionnaire and scales for assessment of swallow but very few have been validated. The&#xD;
      study will assess the construct validity and reliability of the Turkish version of Pharyngeal&#xD;
      Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</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>Validation of Pharyngeal Residue Severity Rating Scale</measure>
    <time_frame>2 months</time_frame>
    <description>To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Swallowing Disorder</condition>
  <condition>Validation</condition>
  <condition>Pharyngeal Dysphagia</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Health professionals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-70 years&#xD;
&#xD;
          -  at least having undergraduate education on health profession&#xD;
&#xD;
          -  agree to participant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  out of age 18-70 years&#xD;
&#xD;
          -  out of having undergraduate education&#xD;
&#xD;
          -  mental disorder&#xD;
&#xD;
          -  cognitive limitations&#xD;
&#xD;
          -  visual limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melis Ece Arkan Ararat, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ugur Uygan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prof Dr Cemil Tascioglu City Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34384</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>December 26, 2020</last_update_submitted>
  <last_update_submitted_qc>December 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
    <investigator_full_name>Yavuz Atar</investigator_full_name>
    <investigator_title>Associate Professor, M.D.</investigator_title>
  </responsible_party>
  <keyword>Pharyngeal</keyword>
  <keyword>residue</keyword>
  <keyword>swallow</keyword>
  <keyword>scale</keyword>
  <keyword>Yale</keyword>
  <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/NCT04477174
org study id: 308
nct id: NCT04477174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose of the study is the validity and reliability of the Turkish version of the Yale
      Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an
      assessment tool for dysphagia patients.
The swallow function is a multidirectional process that depends on complex neuro-muscular
      network. The function can be evaluated using instrumental, such as fibreoptic endoscopic
      evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many
      questionnaire and scales for assessment of swallow but very few have been validated. The
      study will assess the construct validity and reliability of the Turkish version of Pharyngeal
      Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.
observational model: Other
time perspective: Prospective
measure: Validation of Pharyngeal Residue Severity Rating Scale
time frame: 2 months
description: To match between Fiberoptic Endoscopic Evaluation of Swallowing Images with Yale Pharyngeal Residue Severity Rating Scale Scores by health professionals. High match scores give high reliability, low match scores give low reliability. Match scores were compared and evaluated as statistically. High match score is better, low score is worse.
arm group label: Group A
description: Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores. After 2 weeks, the participants match again.
arm group label: Group B
description: Twelve health professionals randomised assign to as equally count. The participants match between the images with scale scores.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melis Ece Arkan Ararat, MD
role: Principal Investigator
affiliation: University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
last name: Ugur Uygan, MD
role: Principal Investigator
affiliation: University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: Yavuz Atar
investigator title: Associate Professor, M.D.
mesh term: Deglutition Disorders
sharing ipd: No