NCT03787524|UnknownDMC
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Sponsor study identifier
observational
68
1 country
1
Study Start
March 4, 2019
Actual (reported)Primary Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 .
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2018
Actual (reported)December 26, 2018
Actual (reported)March 4, 2019
Actual (reported)January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change of Body mass index (Kg/m2)
Body mass index (Kg/m2)
1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Check the Penetration/aspiration on PAS
1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Change of Grasping force (kg)
1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Change of Korean-modified Barthel index
1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Change of Swallowing-Quality of Life
1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Acute stroke patients who will be diagnosed dysphagia according to VFSS results.
Acute stroke patient who showed no dysphagia according to VFSS results.
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.
Ulsan University Hospital
Ulsan, 682-714, South Korea
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
First Submitted
December 21, 2018
First Posted
December 26, 2018
Study Start
March 4, 2019
Actual (reported)Primary Completion
January 31, 2021
Estimated (date passed)Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 17, 2019
Record last verified: 2019-12
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