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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03787524
Enrollment
68
Registered
2018-12-26
Start date
2019-03-04
Completion date
2021-01-31
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Dysphagia

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.

Interventions

None listed

Sponsors

Ulsan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 onsetBody mass index (Kg/m2)

Secondary

MeasureTime frameDescription
Check the Penetration/aspiration on PAS1 day after the VFSS, 3 month, 6 months and 9 months after the stroke onsetPenetration/aspiration on PAS (DYS)

Other

MeasureTime frameDescription
Change of Swallowing-Quality of Life1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onsetSwallowing-Quality of Life: 1-44: the higher, the worse
Check the Aspiration pneumonia1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onsetnumber of participants diagnosed aspiration pneumonia
Change of Eating Assessment Tool1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onsetEating Assessment Tool
change of Video-fluoroscopic Dysphagia Scale1 day after the VFSSVideo-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse
Change of Korean-modified Barthel index1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onsetKorean-modified Barthel index: 0-100: the higher, the better
Dynamic Imaging Grade of Swallowing Toxicity1 day after the VFSSDynamic Imaging Grade of Swallowing Toxicity (DIGEST) Scale; 0-4; the higher, the worse
Dysphagia Item of Common Terminology Criteria for Adverse Events1 day after the VFSSDysphagia-related Item score, based on the Common Terminology Criteria for Adverse Events (CTCAE); 0-4; the higher, the worse
American Speech-Language Hearing Association National Outcomes Measurements System Swallowing Scale1 day after the VFSSAmerican Speech-Language Hearing Association National Outcomes;Measurements System Swallowing Scale (ASHA NOMS); 1-7; the higher, the better
Confirmation of death3 month, 6 months and 9 months after the stroke onsetnumber of participant of death confirmation
Modified Barium Swallowing Study Impairment Profile1 day after the VFSSModified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse
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 onsetGrasping force (kg)

Countries

South Korea

Contacts

Primary ContactChang Ho Hwang
chhwang1220ciba@gmail.com+82-52-250-7210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026