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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 .
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Check the Penetration/aspiration on PAS | Penetration/aspiration on PAS (DYS) | 1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Grasping force (kg) | 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 | Korean-modified Barthel index: 0-100: the higher, the better |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ho Hwang | Contact | +82-52-250-7210 | chhwang1220ciba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ho Hwang, M.D., Ph.D. | Ulsan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Recruiting | Ulsan | 682-714 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 | Swallowing-Quality of Life: 1-44: the higher, the worse | 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset |
| Check the Aspiration pneumonia | number of participants diagnosed aspiration pneumonia | 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset |
| Change of Eating Assessment Tool | Eating Assessment Tool | 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset |
| change of Video-fluoroscopic Dysphagia Scale | Video-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse | 1 day after the VFSS |
| Modified Barium Swallowing Study Impairment Profile | Modified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse | 1 day after the VFSS |
| Dynamic Imaging Grade of Swallowing Toxicity | Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale; 0-4; the higher, the worse | 1 day after the VFSS |
| Dysphagia Item of Common Terminology Criteria for Adverse Events | Dysphagia-related Item score, based on the Common Terminology Criteria for Adverse Events (CTCAE); 0-4; the higher, the worse | 1 day after the VFSS |
| American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale | American Speech-Language Hearing Association National Outcomes;Measurements System Swallowing Scale (ASHA NOMS); 1-7; the higher, the better | 1 day after the VFSS |
| Confirmation of death | number of participant of death confirmation | 3 month, 6 months and 9 months after the stroke onset |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |