Non-standardized vs. Standardized Screening for Dysphagia

NCT ID: NCT05603897

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2026-01-30

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).

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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 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).

Group Type OTHER

Non-standardized clinical swallow evaluation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Non-standardized clinical swallow evaluation

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Gemayaret Alvarez

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gemayaret Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Lynn Rehabilitation Center / University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gemayaret Alvarez, MD

Role: CONTACT

305-585-9420

Claudia Santesteban-bidot, M.S.

Role: CONTACT

305-585-9449

Facility Contacts

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Gemayaret Alvarez, MD

Role: primary

305-243-6605

Claudia Santesteban-bidot, MS

Role: backup

305-585-9449

Other Identifiers

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20220558

Identifier Type: -

Identifier Source: org_study_id

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