Comparing two tests for swallowing difficulties after a stroke
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
NA · University of Miami · NCT05603897
This study is testing which of two different tests is better at finding swallowing problems in people who have just had a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT05603897 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two different screening methods for detecting dysphagia, or difficulty swallowing, in patients who have recently experienced an ischemic stroke. The interventions include the Mann Assessment of Swallowing Ability (MASA) and a non-standardized clinical swallow evaluation. By assessing these methods, the study seeks to determine which screening approach is more effective in identifying dysphagia and the associated risk of aspiration. The findings could help improve patient care and outcomes for those recovering from stroke.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been admitted to the Lynn Rehabilitation Center with an acute ischemic stroke diagnosis within the past month.
Not a fit: Patients over 80 years old, pregnant women, prisoners, those with a prior history of dysphagia, or those with certain acute intracranial conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely detection of swallowing difficulties in stroke patients, potentially reducing the risk of aspiration and improving recovery.
How similar studies have performed: While this study explores a comparative approach, similar studies have shown varying success in screening for dysphagia, indicating that this area is still evolving.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida
- Lynn Rehabilitation Center / University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Gemayaret Alvarez, MD — University of Miami
- Study coordinator: Gemayaret Alvarez, MD
- Email: g.alvarez3@med.miami.edu
- Phone: 305-585-9420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dysphagia, difficulty swallowing