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Clinical Trials/NCT03787524
NCT03787524
Unknown
Not Applicable

Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke: Prospective, Observational, Parallel Group, Case-control Trial

Ulsan University Hospital1 site in 1 country68 target enrollmentMarch 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Stroke
Sponsor
Ulsan University Hospital
Enrollment
68
Locations
1
Primary Endpoint
Change of Body mass index (Kg/m2)
Last Updated
6 years ago

Overview

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 .

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2019
End Date
January 31, 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chang Ho Hwang

Associate Professor

Ulsan University Hospital

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Check the Penetration/aspiration on PAS(1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset)

Study Sites (1)

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