Screening Methods for Swallowing Disorders

Overseen by Gemayaret Alvarez, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Age > 80, Pregnancy, Prisoners, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 4 5 6}

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. ^{1 2 4 5 6}

Research Team

Gemayaret Alvarez, MD

Principal Investigator

University of Miami

Eligibility Criteria

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 am 18 years old or older.

I was admitted to Lynn Rehabilitation Center for a recent stroke.

I can understand instructions in English or Spanish.

Exclusion Criteria

I am over 80 years old.

Pregnant women

Prisoners

Trial Timeline

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

Treatment Details

Interventions

• Mann Assessment of Swallowing Ability (MASA) (dysphagia screening tool) (Behavioural Intervention)
• Non-standardized clinical swallow evaluation (Behavioural Intervention)

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.

Participant Groups

Group I: Non-standardized clinical swallow evaluation Group Experimental Treatment 1 Intervention

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 II: Mann Assessment of Swallowing Ability (MASA) Group Experimental Treatment 1 Intervention

Participants in this group will receive the MASA dysphagia screening once upon admission to inpatient rehabilitation for approximately 20 minutes.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Mann Assessment of Swallowing Ability (MASA) demonstrated good diagnostic accuracy for identifying dysphagia and aspiration risk in stroke patients, with an area under the curve (AUC) of 0.85 for dysphagia and 0.84 for aspiration.

New optimal cutoff scores of ≤146 for both dysphagia and aspiration improved specificity and sensitivity, making the MASA a reliable predictor of pneumonia during hospitalization and over a year, as well as mortality, with AUCs of 0.85, 0.86, and 0.79 respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent and predictive validity of the Mann Assessment of Swallowing Ability in Belgian acute stroke patients based on a one-year follow-up study. Simpelaere, IS., Hansen, T., Roelant, E., et al.[2023]

The Mann Assessment of Swallowing Ability (MASA) was not effective in distinguishing between children with cerebral palsy who aspirate and those who do not, nor between silent and overt aspirators, based on a study of 16 patients.

However, MASA scores were able to predict oral dysfunction in swallowing, showing a significant correlation with certain aspects of the Functional Dysphagia Scale (FDS), particularly in the oral phase of swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Predicting Videofluoroscopic Results in Dysphagic Patients with Severe Cerebral Palsy Using the Mann Assessment of Swallowing Ability. Su, CL., Chen, SL., Tsai, SW., et al.[2016]

The Turkish version of the Mann Assessment of Swallowing Ability (T-MASA) has been shown to be a reliable and valid tool for assessing dysphagia in 141 stroke patients, with excellent internal consistency (Cronbach’s alpha of 0.899–0.901).

There is a significant moderate negative correlation between the T-MASA scores and endoscopic evaluations of dysphagia, indicating that lower T-MASA scores are associated with the presence of swallowing difficulties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The psychometric evaluation of the Turkish version of the Mann Assessment of Swallowing Ability in patients in the early period after stroke Karaca Umay, E., Gündoğdu, İ., Gürçay, E., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical experience using the Mann assessment of swallowing ability for identification of patients at risk for aspiration in a mixed-disease population. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of a dysphagia screening system based on the Mann Assessment of Swallowing Ability for use in dependent older adults. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Predicting Videofluoroscopic Results in Dysphagic Patients with Severe Cerebral Palsy Using the Mann Assessment of Swallowing Ability. [2016]

6. Turkey pubmed.ncbi.nlm.nih.gov

The psychometric evaluation of the Turkish version of the Mann Assessment of Swallowing Ability in patients in the early period after stroke [2019]