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Recruiting NCT07549724

Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation

Observational Dysphagia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: dysphagia assessment.
Who it may be relevant to
Registry conditions: Dysphagia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test dysphagia assessment
    no intervention but validation of assessments

Primary outcome measures

  • Internal consistency of secretion and drooling scales [Time frame: Baseline]
Secondary outcome measures (1)
  • Inter-rater reliability of secretion, drooling, and swallowing assessment scales [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS San Camillo — Venezia

Identifiers

NCT: NCT07549724 · 6111/S.Camillo/24 · Italian Ministry of Health

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗