Back to resultsNon-standardized vs. Standardized Screening for Dysphagia
Primary Purpose
Dysphagia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)
Non-standardized clinical swallow evaluation
Sponsored by
About this trial
This is an interventional screening trial for Dysphagia focused on measuring difficulty swallowing
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
Sites / Locations
- Lynn Rehabilitation Center / University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Mann Assessment of Swallowing Ability (MASA) Group
Non-standardized clinical swallow evaluation Group
Arm Description
Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05603897
Brief Title
Non-standardized vs. Standardized Screening for Dysphagia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 31, 2024 (Anticipated)
Primary Completion Date
January 4, 2025 (Anticipated)
Study Completion Date
January 4, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
difficulty swallowing
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mann Assessment of Swallowing Ability (MASA) Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.
Arm Title
Non-standardized clinical swallow evaluation Group
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)
Intervention Description
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
Intervention Name(s)
Non-standardized clinical swallow evaluation
Intervention Description
Participants will receive current standard of care for dysphagia screening and treatment.
Primary Outcome Measure Information:
Title
Dysphagia measured by MASA
Description
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.
Time Frame
Up to 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gemayaret Alvarez, MD
Phone
305-585-9420
Email
g.alvarez3@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Santesteban-bidot, M.S.
Phone
305-585-9449
Email
claudia.santesteban@jhsmiami.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemayaret Alvarez, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lynn Rehabilitation Center / University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Acosta, MD
Phone
305-585-9420
Email
oliver.acosta@jhsmiami.org
First Name & Middle Initial & Last Name & Degree
Claudia Santesteban-bidot, MS
Phone
305-585-9449
Email
claudia.santesteban@jhsmiami.org
First Name & Middle Initial & Last Name & Degree
Oliver Acosta, MD
First Name & Middle Initial & Last Name & Degree
Gemayaret Alvarez, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Non-standardized vs. Standardized Screening for Dysphagia
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