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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787524
• Other study ID #: chhwang12
• Status: Recruiting
• Start date: March 4, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: December 2019
• Source: Ulsan University Hospital
• Contact: Chang Ho Hwang
• Phone: +82-52-250-7210
• Email: chhwang1220ciba[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Deglutition Disorders
• Dysphagia
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change of Korean-modified Barthel index	Korean-modified Barthel index: 0-100: the higher, the better	1 day before and 1 day, 3 weeks after the VFSS, 3 month, 6 months and 9 months after the stroke onset
Other	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
Other	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
Other	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
Other	change of Video-fluoroscopic Dysphagia Scale	Video-fluoroscopic Dysphagia Scale (VDS); 0-100; the higher, the worse	1 day after the VFSS
Other	Modified Barium Swallowing Study Impairment Profile	Modified Barium Swallowing Study Impairment Profile (MBSImP); 0-62; the higher, the worse	1 day after the VFSS
Other	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
Other	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
Other	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
Other	Confirmation of death	number of participant of death confirmation	3 month, 6 months and 9 months after the stroke onset
Primary	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	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