Italian versions of swallowing and drooling assessment tools for adults with neurogenic dysphagia
Clinical and Instrumental Assessment Tools for Neurogenic Dysphagia: Translation and Validation
This project will test Italian versions of several swallowing and drooling assessment tools in adults with neurogenic dysphagia to see if they are reliable and usable.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | IRCCS San Camillo, Venezia, Italy Academic / other |
| Locations | 1 site (Venezia, Italy) |
| Trial ID | NCT07549724 on ClinicalTrials.gov |
What this trial studies
Researchers will translate and culturally adapt four established instruments—the New Zealand Secretion Severity Scale, the Reflex Cough Test, the VASES used during fiberoptic endoscopic evaluation of swallowing (FEES), and the Drooling Severity Scale—into Italian. About 100 adult patients with neurogenic dysphagia from various neurological conditions will be enrolled at a single center in Venice. The protocol is observational and will examine measurement properties such as inter-rater and intra-rater reliability, and validity against clinical and instrumental swallowing findings. The goal is to produce standardized, linguistically and psychometrically validated Italian tools for use in routine clinical and research settings.
Who should consider this trial
Good fit: Adults (18 years or older) with neurogenic dysphagia from any neurological condition who are medically stable and able to provide informed consent are ideal candidates.
Not a fit: People with an active respiratory infection, recent head or neck surgery or anatomical abnormalities preventing standardized assessment, or severe uncontrolled comorbidities are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, clinicians in Italy would have reliable, standardized Italian tools to better identify and monitor swallowing and drooling problems and guide treatment decisions.
How similar studies have performed: The individual instruments are established and have been validated in other languages, but validated Italian versions are new and have not yet been tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Venezia, Italy
- IRCCS San Camillo — Venezia, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Sara Nordio
- Email: sara.nordio@hsancamillo.it
- Phone: 3494990310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.