Clinical trial NCT03787524: Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke
Official title: Prediction of Functional Health Status and Aspiration Using Multiple Dysphagia Scales Over 6 Months After Acute Stroke: Prospective, Observational, Parallel Group, Case-control Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Dysphagia
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Change of Body mass index (Kg/m2)
timeFrame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Secondary outcomes:
measure: Check the Penetration/aspiration on PAS
timeFrame: 1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Other outcomes:
measure: Change of Grasping force (kg)
timeFrame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
measure: Change of Korean-modified Barthel index
timeFrame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
measure: Change of Swallowing-Quality of Life
timeFrame: 1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
measure: Check the Aspiration pneumonia
timeFrame: 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
measure: Change of Eating Assessment Tool
timeFrame: 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
measure: change of Video-fluoroscopic Dysphagia Scale
timeFrame: 1 day after the VFSS
measure: Modified Barium Swallowing Study Impairment Profile
timeFrame: 1 day after the VFSS
measure: Dynamic Imaging Grade of Swallowing Toxicity
timeFrame: 1 day after the VFSS
measure: Dysphagia Item of Common Terminology Criteria for Adverse Events
timeFrame: 1 day after the VFSS
measure: American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale
timeFrame: 1 day after the VFSS
measure: Confirmation of death
timeFrame: 3 month, 6 months and 9 months after the stroke onset
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: