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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05603897
Enrollment
50
Registered
2022-11-03
Start date
2024-04-05
Completion date
2026-11-30
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

difficulty swallowing

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).

Interventions

OTHERMann 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.

OTHERNon-standardized clinical swallow evaluation

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

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dysphagia measured by MASAUp to 20 minutesThe 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.

Countries

United States

Contacts

CONTACTGemayaret Alvarez, MD
g.alvarez3@med.miami.edu305-585-9420
CONTACTClaudia Santesteban-bidot, M.S.
claudia.santesteban@jhsmiami.org305-585-9449
PRINCIPAL_INVESTIGATORGemayaret Alvarez, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026