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Recruiting NCT05603897

Non-standardized vs. Standardized Screening for Dysphagia

No phase Interventional Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool), Non-standardized clinical swallow evaluation.
Who it may be relevant to
Registry conditions: Dysphagia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Lynn Rehabilitation Center / University of Miami — Miami

Identifiers

NCT: NCT05603897 · 20220558

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗