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

ConditionDysphagia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorIRCCS San Camillo, Venezia, Italy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

people with neurogenic dysphagia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • dysphagia assessment

    Diagnostic test

    no intervention but validation of assessments

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline

Secondary outcomes

1

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)

Time frame
baseline

Other outcomes

1

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
Time Frame: Baseline and 7 days
2

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
Time Frame: Baseline

Sponsors and contacts

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