Screening Methods for Swallowing Disorders

Overseen By Gemayaret Alvarez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Age > 80, Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for assessing swallowing issues in individuals who recently experienced an ischemic stroke (a type of stroke caused by a blood clot). The study will evaluate how effectively these methods detect problems such as dysphagia (difficulty swallowing) and the risk of aspiration (food or drink entering the lungs without a cough). One group will use the Mann Assessment of Swallowing Ability (MASA), a dysphagia screening tool, while the other will undergo a non-standardized clinical evaluation. This trial may suit individuals who had a stroke in the past month and are currently in inpatient rehabilitation. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance future stroke rehabilitation methods.

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 prior data suggests that these screening methods are safe for detecting swallowing disorders?

Research shows that the Mann Assessment of Swallowing Ability (MASA) is generally safe for assessing swallowing problems. The MASA evaluates swallowing ability by examining 24 different areas and primarily recommends safe types of food and drinks for individuals.

The MASA is particularly beneficial for older adults who require assistance with eating and swallowing. No reports indicate harm or side effects from its use. However, it may not always detect swallowing issues in individuals with good mental function due to its limited sensitivity.

Overall, the MASA is a well-tolerated method for identifying swallowing problems, and safety concerns are minimal. For those considering a trial using the MASA, it is regarded as safe and non-invasive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare two different methods for screening swallowing disorders, or dysphagia. The Mann Assessment of Swallowing Ability (MASA) offers a structured and standardized approach, potentially leading to more reliable and consistent results than non-standardized evaluations. By comparing MASA with the usual care, researchers hope to determine if a standardized tool can improve the accuracy of dysphagia screening, ultimately enhancing patient care in rehabilitation settings.

What evidence suggests that these screening methods are effective for detecting dysphagia?

Research has shown that the Mann Assessment of Swallowing Ability (MASA), used in one arm of this trial, reliably checks swallowing issues in stroke patients. Studies have found that MASA can identify those at risk for dysphagia, or trouble swallowing, and aspiration, when food or liquid enters the lungs accidentally. Although MASA is effective, it has limitations, such as being less effective in individuals with strong cognitive skills, which may lead to missed cases. Overall, MASA is considered a trustworthy tool for evaluating swallowing ability after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Pregnant women

Prisoners

Those with a prior history of dysphagia

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?

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

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. Antonios, N., Carnaby-Mann, G., Crary, M., et al.[2022]

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 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 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]

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]

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]

Citations

1. sralab.org sralab.org/rehabilitation-measures/mann-assessment-swallowing-ability-masa

Mann Assessment of Swallowing Ability (MASA) Mean MASA Score for the 54 patients identified with dysphagia was 136.7 (SD:50) · Mild dysphagia in 21 patients with a score range = 168-177 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6906202/

Assessment of Aspiration Risk Using the Mann ... This study results demonstrated that patients with good cognitive function may have false negative results of MASA screening due to low sensitivity.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1016319016300088

Validity and reliability of swallowing screening tools used ... The Standardized Swallowing Assessment is the most suitable tool for detecting dysphagia because its psychometric properties and feasibility are higher.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430460/

Evaluation of Psychometric Proprieties of Mann ... The Italian version of the Mann Assessment of Swallowing Ability (MASA-IT) is a reliable and valid tool for assessing swallowing ability in post-stroke ...

5. carolinatherapy.net carolinatherapy.net/wp-content/uploads/MASA.pdf

MASA: The Mann Assessment of Swallowing Ability Record accu- racy, agility, and spontaneous versus imitative productions. 5 = No abnormality detected on screening. 4. = Speech accurate after trial and ...

6. ahajournals.org ahajournals.org/doi/10.1161/str.0b013e3182877f57

Dysphagia Screening: State of the Art | Stroke Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. J Stroke Cerebrovasc ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/ggi.12755

Evaluation of a dysphagia screening system based on the ... The MASA is a useful screening tool for evaluating eating and swallowing functions in dependent older adults. ... MASA: The Mann Assessment of ...