50 Participants Needed

Screening Methods for Swallowing Disorders

CS
OA
GA
Overseen ByGemayaret Alvarez, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying ways to check for swallowing problems in stroke patients. It focuses on people who have had a stroke because they often have trouble swallowing. The tests help doctors find out if these patients are at risk of health issues from swallowing difficulties.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Mann Assessment of Swallowing Ability (MASA) safe for humans?

The Mann Assessment of Swallowing Ability (MASA) is a tool used to evaluate swallowing disorders, particularly after a stroke, and has been used safely in various studies with stroke patients and older adults. It is a non-invasive assessment, meaning it does not involve surgery or entering the body, which generally makes it safe for human use.12345

How is the Mann Assessment of Swallowing Ability (MASA) treatment different from other treatments for swallowing disorders?

The Mann Assessment of Swallowing Ability (MASA) is unique because it is a standardized tool specifically designed to assess swallowing ability and predict risks like aspiration (food or liquid entering the airway) in patients, especially after a stroke. Unlike other methods, it can be administered at the bedside, making it convenient for early diagnosis and management of swallowing disorders.12346

What data supports the effectiveness of the treatment Mann Assessment of Swallowing Ability (MASA) for swallowing disorders?

Research shows that the Mann Assessment of Swallowing Ability (MASA) is effective in predicting swallowing problems, like aspiration (when food or liquid goes into the lungs), in patients with conditions such as severe cerebral palsy and stroke. It has been used successfully in different patient groups, including older adults, to identify those at risk of swallowing difficulties.12456

Who Is on the Research Team?

GA

Gemayaret Alvarez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who've had an ischemic stroke within the last month and are at Lynn Rehabilitation Center. They must understand English or Spanish, be able to consent (or have a proxy do so), and not have a history of swallowing issues or certain brain injuries.

Inclusion Criteria

I was admitted to Lynn Rehabilitation Center for a recent stroke.
I can understand instructions in English or Spanish.
I can give my consent, or someone can do it for me if I'm unable.

Exclusion Criteria

I am over 80 years old.
Pregnant women
Prisoners
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive either the MASA dysphagia screening or a non-standardized clinical swallow evaluation upon admission to inpatient rehabilitation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for recovery and effectiveness of the dysphagia screening

Duration not specified

What Are the Treatments Tested in This Trial?

Interventions

  • Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool)
  • Non-standardized clinical swallow evaluation
Trial Overview The study compares two tests for dysphagia after an ischemic stroke: one is a non-standardized clinical evaluation, and the other uses the Mann Assessment of Swallowing Ability. It aims to identify which better detects swallowing difficulties and aspiration risk.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Non-standardized clinical swallow evaluation GroupExperimental Treatment1 Intervention
Group II: Mann Assessment of Swallowing Ability (MASA) GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Published Research Related to This Trial

In a study of 133 patients evaluated for swallowing ability, the Mann Assessment of Swallowing Ability (MASA) showed that the Ordinal Risk Rating (ORR) effectively predicted aspiration risk, identifying 40.6% of patients as having probable or definite aspiration.
The study found that the ORR had a good predictive ability with an area under the ROC curve of 0.74, while the Total Numeric Score (TNS) was not effective in predicting aspiration, indicating that the ORR is a more reliable assessment tool for this purpose.
Clinical experience using the Mann assessment of swallowing ability for identification of patients at risk for aspiration in a mixed-disease population.González-Fernández, M., Sein, MT., Palmer, JB.[2016]
The Modified Mann Assessment of Swallowing Ability (MMASA) was developed as a physician-administered tool for dysphagia screening in acute ischemic stroke, showing good interobserver agreement (k=0.76) among two neurologists who assessed 150 patients.
The MMASA demonstrated high sensitivity (up to 92%) and specificity (up to 86.3%) compared to the standard MASA, indicating it is a reliable tool for early identification of dysphagia, which can lead to quicker interventions for stroke patients.
Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability.Antonios, N., Carnaby-Mann, G., Crary, M., et al.[2022]
The Mann Assessment of Swallowing Ability (MASA) is an effective tool for screening dysphagia in dependent older adults, with optimal cut-off values identified at 122 points for predicting aspiration and 151 points for pharyngeal retention.
Out of 24 clinical items assessed by the MASA, 17 were significantly associated with aspiration, highlighting the tool's utility in identifying specific swallowing difficulties in this population.
Evaluation of a dysphagia screening system based on the Mann Assessment of Swallowing Ability for use in dependent older adults.Ohira, M., Ishida, R., Maki, Y., et al.[2018]

Citations

Clinical experience using the Mann assessment of swallowing ability for identification of patients at risk for aspiration in a mixed-disease population. [2016]
Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. [2022]
Evaluation of a dysphagia screening system based on the Mann Assessment of Swallowing Ability for use in dependent older adults. [2018]
Concurrent and predictive validity of the Mann Assessment of Swallowing Ability in Belgian acute stroke patients based on a one-year follow-up study. [2023]
Efficacy of Predicting Videofluoroscopic Results in Dysphagic Patients with Severe Cerebral Palsy Using the Mann Assessment of Swallowing Ability. [2016]
The psychometric evaluation of the Turkish version of the Mann Assessment of Swallowing Ability in patients in the early period after stroke [2019]
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