Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke
1 other identifier
observational
68
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 26, 2018
CompletedStudy Start
First participant enrolled
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedDecember 17, 2019
December 1, 2019
1.9 years
December 21, 2018
December 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Check the Penetration/aspiration on PAS
1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Other Outcomes (11)
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
- +8 more other outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- brain MRI / CT-based stroke patients who were referred for VFSS
You may not qualify if:
- In case of a history of dysphagia
- Unstable patient in neurology
- or higher of NIHSS 1a (level of consciousness)
- Patients with other neurological diseases
- Patients with decompression skull resection
- Refusal of participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 21, 2018
First Posted
December 26, 2018
Study Start
March 4, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
December 17, 2019
Record last verified: 2019-12