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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07549724
Acronym
Val_Dysphagia
Enrollment
100
Registered
2026-04-24
Start date
2025-03-09
Completion date
2028-12-30
Last updated
2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Brief summary

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_TESTdysphagia assessment

no intervention but validation of assessments

Sponsors

IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Internal consistency of secretion and drooling scalesBaselineDescription: 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)

Secondary

MeasureTime frameDescription
Inter-rater reliability of secretion, drooling, and swallowing assessment scalesbaselineInter-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)

Countries

Italy

Contacts

CONTACTSara Nordio
sara.nordio@hsancamillo.it3494990310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026