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NCT Number: NCT05603897

Non-standardized vs. Standardized Screening for Dysphagia

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).

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lynn Rehabilitation Center / University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Claudia Santesteban-bidot, MS

CONTACT

[email protected]

305-585-9449

Gemayaret Alvarez, MD

CONTACT

[email protected]

305-243-6605

Gemayaret Alvarez, MD

PRINCIPAL_INVESTIGATOR

Sarah Kurtevski, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Non-standardized clinical swallow evaluation

Other

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

Primary outcomes

  1. Dysphagia measured by MASA

    Time frame: Up to 20 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Santesteban-bidot, M.S.

CONTACT

[email protected]

305-585-9449

Gemayaret Alvarez, MD

CONTACT

[email protected]

305-585-9420

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2022
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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