Non-standardized vs. Standardized Screening for Dysphagia

Dysphagia Clinical Trial

Official title:

Utility of Non-standardized Clinical Swallow Evaluation vs. Standardized Swallow Evaluation to Identify the Presence of Dysphagia and Risk for Aspiration in Patients Post-ischemic Stroke in Acute Inpatient Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603897
• Other study ID #: 20220558
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: January 4, 2025

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Gemayaret Alvarez, MD
• Phone: 305-585-9420
• Email: g.alvarez3[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 4, 2025
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults = 18 years old

• Patients admitted to Lynn Rehabilitation Center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month

• Patients able to provide informed, written consent. If patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone

• Able to read and comprehend verbal instruction in English and/or Spanish

Exclusion Criteria:

• Adults > 80 years old

• Pregnant women

• Prisoners

• Those with a prior history of dysphagia

• Those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Other:
• Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)
Upon 1-2 days of admission to inpatient rehabilitation, the MASA will be administered for approximately 20 minutes during initial speech language pathology evaluation. The MASA will be administered at bedside as a cognitive/speech language evaluation as well as oropharyngeal function examination.
• Non-standardized clinical swallow evaluation
Participants will receive current standard of care for dysphagia screening and treatment.

Locations

Country	Name	City	State
United States	Lynn Rehabilitation Center / University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia measured by MASA	The MASA is a 24-item clinical test that evaluates swallowing in the order in which swallowing phases occur. Each item is quantitatively scored using either a 5-point or 10-point score at the end of which a total score out of 200 is summed up. The MASA takes approximately 15-20 minutes to perform and can then be repeated during a patient's clinical course to monitor for recovery.	Up to 20 minutes