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

• Conditions: Dysphagia; Acute Stroke

• Registration Number: NCT03787524
• Lead Sponsor: 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 .

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.

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-26
• Study Start: 2019-03-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-15
• Last Update Posted: 2019-12-17
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of 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	Body mass index (Kg/m2)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of