Non-standardized vs. Standardized Screening for Dysphagia

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

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).

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Other: Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool); Other: Non-standardized clinical swallow evaluation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Santesteban-bidot, M.S.; Phone Number: 305-585-9449; Email: claudia.santesteban@jhsmiami.org
• Study Contact Backup: Name: Gemayaret Alvarez, MD; Phone Number: 305-585-9420; Email: g.alvarez3@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Lynn Rehabilitation Center / University of Miami
      • Contact: Claudia Santesteban-bidot, MS; Phone Number: 305-585-9449; Email: claudia.santesteban@jhsmiami.org
      • Contact: Gemayaret Alvarez, MD; Phone Number: 305-243-6605; Email: g.alvarez3@miami.edu
      • Principal Investigator: Gemayaret Alvarez, MD
      • Sub-Investigator: Sarah Kurtevski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mann Assessment of Swallowing Ability (MASA) Group; Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.	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.
Other: Non-standardized clinical swallow evaluation Group; Participants in this group will receive standard of care treatment (dysphagia screening once upon admission to inpatient rehabilitation using a non-standardized clinical swallow evaluation for approximately 15 minutes).	Other: Non-standardized clinical swallow evaluation; Participants will receive current standard of care for dysphagia screening and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Gemayaret Alvarez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: difficulty swallowing
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders; methyl N-acetylsibirosaminide
• Other Study ID Numbers: 20220558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No