Non-standardized Vs. Standardized Screening for Dysphagia

Not Applicable

Recruiting

• Conditions: Dysphagia
• Interventions: Other: Non-standardized clinical swallow evaluation; Other: Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)

• Registration Number: NCT05603897
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-03
• Study Start: 2024-04-05
• Status Verified: 2024-06
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-standardized clinical swallow evaluation Group	Non-standardized clinical swallow evaluation	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).
Mann Assessment of Swallowing Ability (MASA) Group	Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)	Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.

Primary Outcome Measures

Name	Time	Method
Dysphagia measured by MASA	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.

Trial Locations

Locations (1)

Lynn Rehabilitation Center / University of Miami; 🇺🇸 Miami, Florida, United States