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

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: Active, not recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Other: Clinical assessment tool

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: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Presence of tracheostomy tube and secretion management status	Assessment of tracheostomy tube presence and secretion management in relation to nutritional modality (oral vs non-oral feeding).	7 days

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): December 3, 2024
• Study Completion (Estimated): May 22, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID 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