<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/NCT03787524</url>
  </required_header>
  <id_info>
    <org_study_id>chhwang12</org_study_id>
    <nct_id>NCT03787524</nct_id>
  </id_info>
  <brief_title>Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke</brief_title>
  <official_title>Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke: Prospective, Observational, Parallel Group, Case-control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ulsan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In order to discover dysphagia scales, which shows meaningful predictability of aspiration&#xD;
      and functional health status in patients with acute stroke, authors plan to find out more&#xD;
      predictable indicators than existing penetration-aspiration scale (PAS) to validate their&#xD;
      predictions and their internal and external validity over 6 months following stroke .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the dysphagia scale with significant predictions of aspiration and functional&#xD;
      health status in patients with acute stroke, video-fluoroscopic swallowing study (VFSS) will&#xD;
      be performed to the patients who will be referred for VFSS among stroke patients who would be&#xD;
      diagnosed by Brain MRI / CT. When any type of dysphagia is found, participant will be&#xD;
      assigned to the test group (DYS), and when no dysphagia is found, they will be assigned to&#xD;
      the control group (NOD).&#xD;
&#xD;
      Numerous kinds of assessment will be conducted before and after VFSS, before discharge, and&#xD;
      3, 6, and 9 months after the stroke onset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Change of Body mass index (Kg/m2)</measure>
    <time_frame>1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Body mass index (Kg/m2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Check the Penetration/aspiration on PAS</measure>
    <time_frame>1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Penetration/aspiration on PAS (DYS)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Grasping force (kg)</measure>
    <time_frame>1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Grasping force (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Korean-modified Barthel index</measure>
    <time_frame>1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Korean-modified Barthel index: 0-100: the higher, the better</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Swallowing-Quality of Life</measure>
    <time_frame>1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Swallowing-Quality of Life: 1-44: the higher, the worse</description>
  </other_outcome>
  <other_outcome>
    <measure>Check the Aspiration pneumonia</measure>
    <time_frame>1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>number of participants diagnosed aspiration pneumonia</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Eating Assessment Tool</measure>
    <time_frame>1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>Eating Assessment Tool</description>
  </other_outcome>
  <other_outcome>
    <measure>change of Video-fluoroscopic Dysphagia Scale</measure>
    <time_frame>1 day after the VFSS</time_frame>
    <description>Video-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Barium Swallowing Study Impairment Profile</measure>
    <time_frame>1 day after the VFSS</time_frame>
    <description>Modified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse</description>
  </other_outcome>
  <other_outcome>
    <measure>Dynamic Imaging Grade of Swallowing Toxicity</measure>
    <time_frame>1 day after the VFSS</time_frame>
    <description>Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale; 0-4; the higher, the worse</description>
  </other_outcome>
  <other_outcome>
    <measure>Dysphagia Item of Common Terminology Criteria for Adverse Events</measure>
    <time_frame>1 day after the VFSS</time_frame>
    <description>Dysphagia-related Item score, based on the Common Terminology Criteria for Adverse Events (CTCAE); 0-4; the higher, the worse</description>
  </other_outcome>
  <other_outcome>
    <measure>American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale</measure>
    <time_frame>1 day after the VFSS</time_frame>
    <description>American Speech-Language Hearing Association National Outcomes;Measurements System Swallowing Scale (ASHA NOMS); 1-7; the higher, the better</description>
  </other_outcome>
  <other_outcome>
    <measure>Confirmation of death</measure>
    <time_frame>3 month, 6 months and 9 months after the stroke onset</time_frame>
    <description>number of participant of death confirmation</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Acute Stroke</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Dysphagia group</arm_group_label>
    <description>Acute stroke patients who will be diagnosed dysphagia according to VFSS results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No dysphagia group</arm_group_label>
    <description>Acute stroke patient who showed no dysphagia according to VFSS results.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Based on the raw data of BMI by Batsis et al's report in 2017 (mean value of two groups:&#xD;
        28.5 and 27.6, mean SD of two groups: 1.0), authors calculated total numbers of subjects,&#xD;
        based on the Kang method using G power 3.1. Assuming the between factors analysis using the&#xD;
        F-test of MANOVA, effect size 0.45, α value ≤0.05, power 0.8, number of groups 2, and&#xD;
        number of repeated measures 4 were inputted. Supposed that the dropout rate was 20%, 34&#xD;
        patients in each group were finally calculated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  brain MRI / CT-based stroke patients who were referred for VFSS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In case of a history of dysphagia&#xD;
&#xD;
          -  Unstable patient in neurology&#xD;
&#xD;
          -  2 or higher of NIHSS 1a (level of consciousness)&#xD;
&#xD;
          -  Patients with other neurological diseases&#xD;
&#xD;
          -  Patients with decompression skull resection&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chang Ho Hwang</last_name>
    <phone>+82-52-250-7210</phone>
    <email>chhwang1220ciba@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>682-714</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <phone>+82-52-250-7210</phone>
      <email>chhwang1220ciba@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 15, 2019</last_update_submitted>
  <last_update_submitted_qc>December 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ulsan University Hospital</investigator_affiliation>
    <investigator_full_name>Chang Ho Hwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- 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/NCT03787524
org study id: chhwang12
nct id: NCT03787524
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In order to discover dysphagia scales, which shows meaningful predictability of aspiration
      and functional health status in patients with acute stroke, authors plan to find out more
      predictable indicators than existing penetration-aspiration scale (PAS) to validate their
      predictions and their internal and external validity over 6 months following stroke .
To determine the dysphagia scale with significant predictions of aspiration and functional
      health status in patients with acute stroke, video-fluoroscopic swallowing study (VFSS) will
      be performed to the patients who will be referred for VFSS among stroke patients who would be
      diagnosed by Brain MRI / CT. When any type of dysphagia is found, participant will be
      assigned to the test group (DYS), and when no dysphagia is found, they will be assigned to
      the control group (NOD).

      Numerous kinds of assessment will be conducted before and after VFSS, before discharge, and
      3, 6, and 9 months after the stroke onset.
observational model: Case-Control
time perspective: Prospective
measure: Change of Body mass index (Kg/m2)
time frame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Body mass index (Kg/m2)
measure: Check the Penetration/aspiration on PAS
time frame: 1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Penetration/aspiration on PAS (DYS)
measure: Change of Grasping force (kg)
time frame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Grasping force (kg)
measure: Change of Korean-modified Barthel index
time frame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Korean-modified Barthel index: 0-100: the higher, the better
measure: Change of Swallowing-Quality of Life
time frame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Swallowing-Quality of Life: 1-44: the higher, the worse
measure: Check the Aspiration pneumonia
time frame: 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: number of participants diagnosed aspiration pneumonia
measure: Change of Eating Assessment Tool
time frame: 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
description: Eating Assessment Tool
measure: change of Video-fluoroscopic Dysphagia Scale
time frame: 1 day after the VFSS
description: Video-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse
measure: Modified Barium Swallowing Study Impairment Profile
time frame: 1 day after the VFSS
description: Modified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse
measure: Dynamic Imaging Grade of Swallowing Toxicity
time frame: 1 day after the VFSS
description: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale; 0-4; the higher, the worse
measure: Dysphagia Item of Common Terminology Criteria for Adverse Events
time frame: 1 day after the VFSS
description: Dysphagia-related Item score, based on the Common Terminology Criteria for Adverse Events (CTCAE); 0-4; the higher, the worse
measure: American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale
time frame: 1 day after the VFSS
description: American Speech-Language Hearing Association National Outcomes;Measurements System Swallowing Scale (ASHA NOMS); 1-7; the higher, the better
measure: Confirmation of death
time frame: 3 month, 6 months and 9 months after the stroke onset
description: number of participant of death confirmation
arm group label: Dysphagia group
description: Acute stroke patients who will be diagnosed dysphagia according to VFSS results.
arm group label: No dysphagia group
description: Acute stroke patient who showed no dysphagia according to VFSS results.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chang Ho Hwang, M.D., Ph.D.
role: Study Director
affiliation: Ulsan University Hospital
last name: Chang Ho Hwang
phone: +82-52-250-7210
email: chhwang1220ciba@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ulsan University Hospital
investigator full name: Chang Ho Hwang
investigator title: Associate Professor
mesh term: Deglutition Disorders
mesh term: Stroke