Non-standardized vs. Standardized Screening for Dysphagia

NCT05603897 | Recruiting

• 1 other identifier: 20220558
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dysphagia

Keywords

difficulty swallowing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mann Assessment of Swallowing Ability (MASA) Group

EXPERIMENTAL

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)

Non-standardized clinical swallow evaluation Group

OTHER

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

Interventions

Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool) OTHER

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.

Mann Assessment of Swallowing Ability (MASA) Group

Non-standardized clinical swallow evaluation OTHER

Participants will receive current standard of care for dysphagia screening and treatment.

Non-standardized clinical swallow evaluation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Lynn Rehabilitation Center / University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Interventions

methyl N-acetylsibirosaminide

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gemayaret Alvarez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gemayaret Alvarez, MD

CONTACT

305-585-9420; g.alvarez3@med.miami.edu

Claudia Santesteban-bidot, M.S.

CONTACT

305-585-9449; claudia.santesteban@jhsmiami.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: April 5, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)