Non-standardized vs. Standardized Screening for Dysphagia

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Dysphagia

Intervention / Treatment
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* Other: Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)
* Other: Non-standardized clinical swallow evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mann Assessment of Swallowing Ability (MASA) Group<br>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)<br>* 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.<br>|
| Other: Non-standardized clinical swallow evaluation Group<br>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<br>* Participants will receive current standard of care for dysphagia screening and treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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difficulty swallowing