Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation (Val_Dysphagia)

This study aims to translate and validate Italian versions of several clinical assessment tools for patients with neurogenic dysphagia. The instruments include:

The New Zealand Secretion Severity Scale, which evaluates secretion management; The Reflex Cough Test from the I&I cranial nerves assessment; The VASES scale used during fiberoptic endoscopic evaluation of swallowing; The Drooling Severity Scale, which measures saliva control.

The study will include approximately 100 patients with neurogenic dysphagia. The goal is to provide reliable, standardized tools in Italian to support clinicians in assessing swallowing and oral-motor function in patients with neurological disorders.

Study Overview

• Status: Recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Diagnostic test: dysphagia assessment

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sara Nordio; Phone Number: 3494990310; Email: sara.nordio@hsancamillo.it

Study Locations

• Italy
  • Italy
    • Venezia, Italy, Italy, 30126
      • Recruiting
      • IRCCS San Camillo
      • Contact: Sara Nordio, PhD; Phone Number: 3494990310; Email: sara.nordio@hsancamillo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

people with neurogenic dysphagia

Description

IInclusion Criteria:

Adult patients (≥18 years) diagnosed with neurogenic dysphagia due to any neurological condition (e.g., stroke, Parkinson's disease, multiple sclerosis, traumatic brain injury) Able to understand and comply with study procedures Provide written informed consent (or legal representative consent if necessary) Stable medical and neurological condition at the time of assessment

Exclusion Criteria:

Active respiratory infection or acute illness affecting swallowing at the time of assessment History of head and neck surgery or anatomical abnormalities preventing standardized assessment of swallowing or reflex cough Severe uncontrolled comorbidities (cardiac, pulmonary, or systemic) that make study participation unsafe

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal consistency of secretion and drooling scales	Description: Internal consistency of the New Zealand Secretions Severity Scale (NZSS) and Drooling Severity Scale (DSS). Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Range: NZSS: 0-7 (higher score = greater secretion severity) DSS: 1-5 (higher score = greater drooling severity) Metric: Cronbach's alpha (0-1; higher = better consistency)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater reliability of secretion, drooling, and swallowing assessment scales	Inter-rater reliability of secretion, drooling, and swallowing assessment scales Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Visual Analysis of Swallowing efficiency and safety (VASES) Range: NZSS: 0-7 (higher = worse secretion severity) DSS: 1-5 (higher = worse drooling severity) VASES: - pharyngeal residue: 0-4 (higher = worse residue severity); PAS: 1-8 (higher = worse airway invasion severity) Metric: Intraclass Correlation Coefficient (ICC, 0-1; higher = better reliability)	baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-retest reliability of clinical swallowing and secretion measures	Test-retest reliability of clinical swallowing and secretion measures Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) Reflex Cough Test Range: NZSS: 0-7 DSS: 1-5 Reflex Cough Test: 0-4 (based on increasing citric acid concentrations 0.1-0.4; higher = worse cough reflex sensitivity impairment) Metric: Intraclass Correlation Coefficient (ICC, 0-1; higher = better reliability)	Time Frame: Baseline and 7 days
Construct validity of secretion and drooling scales during FEES	Construct validity of secretion and drooling scales during FEES Scale titles: New Zealand Secretions Severity Scale (NZSS) Drooling Severity Scale (DSS) VASES (Visual Analysis of Swallowing Efficiency and Safety) Range: NZSS: 0-7 DSS: 1-5 VASES: pharyngeal residue: 0-4 (higher = worse residue severity); PAS: 1-8 (higher = worse airway invasion severity) Metric: Correlation coefficients (-1 to +1; absolute value closer to 1 = stronger association)	Time Frame: Baseline

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 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: 6111/S.Camillo/24; Italian Ministry of Health (Other Identifier: IRCCS San Camillo)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No