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Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke

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ClinicalTrials.gov Identifier: NCT03787524
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, Ulsan University Hospital

Brief Summary:
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 .

Condition or disease
Acute Stroke Dysphagia

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 68 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
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
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Dysphagia group
Acute stroke patients who will be diagnosed dysphagia according to VFSS results.
No dysphagia group
Acute stroke patient who showed no dysphagia according to VFSS results.



Primary Outcome Measures :
  1. 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 ]
    Body mass index (Kg/m2)


Secondary Outcome Measures :
  1. Check the Penetration/aspiration on PAS [ Time Frame: 1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset ]
    Penetration/aspiration on PAS (DYS)


Other Outcome Measures:
  1. 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 ]
    Grasping force (kg)

  2. 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 ]
    Korean-modified Barthel index: 0-100: the higher, the better

  3. 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 ]
    Swallowing-Quality of Life: 1-44: the higher, the worse

  4. Check the Aspiration pneumonia [ Time Frame: 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset ]
    number of participants diagnosed aspiration pneumonia

  5. 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 ]
    Eating Assessment Tool

  6. change of Video-fluoroscopic Dysphagia Scale [ Time Frame: 1 day after the VFSS ]
    Video-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse

  7. Modified Barium Swallowing Study Impairment Profile [ Time Frame: 1 day after the VFSS ]
    Modified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse

  8. Dynamic Imaging Grade of Swallowing Toxicity [ Time Frame: 1 day after the VFSS ]
    Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale; 0-4; the higher, the worse

  9. Dysphagia Item of Common Terminology Criteria for Adverse Events [ Time Frame: 1 day after the VFSS ]
    Dysphagia-related Item score, based on the Common Terminology Criteria for Adverse Events (CTCAE); 0-4; the higher, the worse

  10. American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale [ Time Frame: 1 day after the VFSS ]
    American Speech-Language Hearing Association National Outcomes;Measurements System Swallowing Scale (ASHA NOMS); 1-7; the higher, the better

  11. Confirmation of death [ Time Frame: 3 month, 6 months and 9 months after the stroke onset ]
    number of participant of death confirmation



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Based on the raw data of BMI by Batsis et al's report in 2017 (mean value of two groups: 28.5 and 27.6, mean SD of two groups: 1.0), authors calculated total numbers of subjects, based on the Kang method using G power 3.1. Assuming the between factors analysis using the F-test of MANOVA, effect size 0.45, α value ≤0.05, power 0.8, number of groups 2, and number of repeated measures 4 were inputted. Supposed that the dropout rate was 20%, 34 patients in each group were finally calculated.
Criteria

Inclusion Criteria:

  • brain MRI / CT-based stroke patients who were referred for VFSS

Exclusion Criteria:

  • In case of a history of dysphagia
  • Unstable patient in neurology
  • 2 or higher of NIHSS 1a (level of consciousness)
  • Patients with other neurological diseases
  • Patients with decompression skull resection
  • Refusal of participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787524


Contacts
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Contact: Chang Ho Hwang +82-52-250-7210 chhwang1220ciba@gmail.com

Locations
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Korea, Republic of
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of, 682-714
Contact: Chang Ho Hwang, M.D., Ph.D.    +82-52-250-7210    chhwang1220ciba@gmail.com   
Principal Investigator: Chang Ho Hwang, M.D., Ph.D.         
Sponsors and Collaborators
Ulsan University Hospital
Investigators
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Study Director: Chang Ho Hwang, M.D., Ph.D. Ulsan University Hospital

Additional Information:

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Responsible Party: Chang Ho Hwang, Associate Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT03787524     History of Changes
Other Study ID Numbers: chhwang12
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases