Recruiting

Standardized Vs. Non-Standardized

Sponsor:

University of Miami

Code:

NCT05603897

Conditions

Dysphagia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Non-standardized clinical swallow evaluation

Study Details

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

Study ID

NCT05603897

Start date

Apr 5, 2024

Status verified date

Sep, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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: 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).

Interventions

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.

Primary outcome measure

  • Dysphagia measured by MASA [ Time Frame: Up to 20 minutes ]

Central Contacts and Locations

Central contacts

Gemayaret Alvarez, MD

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

Claudia Santesteban-bidot, M.S.

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

Locations

Lynn Rehabilitation Center / University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Gemayaret Alvarez, MD

305-243-6605g.alvarez3@miami.edu

Claudia Santesteban-bidot, MS

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

Principal Investigator:

Gemayaret Alvarez, MD

More Information

Sponsor

University of Miami

Last update posted

Apr 29, 2026

Last verified

Sep, 2025

Keywords

  • difficulty swallowing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-29.