MedDataX Logo

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

NCT ID: NCT03787524

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-04

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Stroke Dysphagia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dysphagia group

Acute stroke patients who will be diagnosed dysphagia according to VFSS results.

No interventions assigned to this group

No dysphagia group

Acute stroke patient who showed no dysphagia according to VFSS results.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chang Ho Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chang Ho Hwang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chang Ho Hwang

Role: CONTACT

Phone: +82-52-250-7210

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chang Ho Hwang, M.D., Ph.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

chhwang12

Identifier Type: -

Identifier Source: org_study_id