Translation and Validation of a Swallowing Assessment Scale for Neurogenic Dysphagia (SCALA_DISF)

April 17, 2026 updated by: Sara Nordio, IRCCS San Camillo, Venezia, Italy
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. Validating the MUCSS in Italian would aid in better managing neurogenic dysphagia patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Neurogenic dysphagia is a swallowing disorder resulting from neurological diseases, primarily characterized by alterations in the oral and pharyngeal phases. Neurogenic dysphagia is a very common disorder, affecting 40-70% of individuals who have had a stroke and 60-80% of those with neurodegenerative diseases in Physical Medicine and Rehabilitation and Neurorehabilitation settings. The main complications of dysphagia are aspiration pneumonia, malnutrition, and dehydration, which can worsen the clinical picture and compromise the patient's quality of life. To identify swallowing disorders early and prevent complications, it is recommended to use standardized screening protocols and clinical evaluation by a speech therapist. If clinical questions remain, further investigation with instrumental exams such as videofluoroscopy (VFS) and/or fibroscopy is indicated. Within clinical evaluation, it is advisable to use outcome scales to objectively determine the severity of the disorder, describe the functional level of swallowing abilities, and monitor the evolution of the function over time.

The Munich Swallowing Score (MUCSS) [Bartolome G, 2021] is a clinical tool used to assess the functional level of saliva/secretions, liquids, and food swallowing. It consists of two scales, each with eight levels: the Munich Swallowing Score-Saliva (MUCSS-S), which evaluates the management of saliva/secretions, and the Munich Swallowing Score-Nutrition (MUCSS-N), which focuses on nutrition.

In the literature, the assessment of saliva/secretions management is still insufficiently explored. Difficulties in swallowing and managing saliva/secretions significantly affect the clinical progress of the patient and their quality of life. In this sense, a scale that considers both saliva/secretions swallowing and the presence of a cannula, in addition to liquid/food swallowing, represents an innovative and useful tool in clinical practice.

The MUCSS is a scale sensitive to the evolution of swallowing abilities, allowing an objective and repeatable evaluation of the management of secretions as well. The translation into Italian and validation of the MUCSS scale would provide an important contribution to the assessment and, consequently, the management of patients with neurogenic dysphagia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VE
      • Lido, VE, Italy, 30126
        • IRCCS San Camillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with dysphagia due to neurological aetiology (stroke, PD, multiple sclerosis, amyotrophic lateral sclerosis, , cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumour or traumatic brain injury)

Description

Inclusion Criteria:

Neurological etiology including stroke, Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis, cerebrovascular infection, spinocerebellar ataxia, myasthenia gravis, anoxia, brain tumor, or traumatic brain injury Diagnosed oropharyngeal dysphagia (OD) confirmed by a neurologist Age ≥ 18 years

Exclusion Criteria:

Inability to maintain a stable sitting position during endoscopy Contraindications to Fiberoptic Endoscopic Evaluation of Swallowing (FEES), including fever or agitation that compromises participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with neurogenic dysphagia
Patients with neurogenic dysphagia of different etiologies (Parkinson's disease, ALS, MS, stroke, traumatic brain injury, severe acquired brain injury)."
Other: Clinical assessment tool
The Munich Swallowing Score (MUCSS) is a tool that evaluates saliva, liquid, and food swallowing abilities using two scales: one for saliva/secretions (MUCSS-S) and one for nutrition (MUCSS-N). It helps objectively assess swallowing function and track changes over time. It is an important outcome to consider the presence of a tracheostomy tube and the management of secretions in relation to nutritional methods.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of tracheostomy tube and secretion management status
Time Frame: 7 days
Assessment of tracheostomy tube presence and secretion management in relation to nutritional modality (oral vs non-oral feeding).
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS San Camillo, Venezia, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022.03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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