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Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration

Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05733494
Enrollment
101
Registered
2023-02-17
Start date
2022-04-05
Completion date
2026-02-16
Last updated
2026-03-02

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

Conditions

Dysphagia, Neuro-Degenerative Disease, Swallowing Disorder

Brief summary

The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population. Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics. The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. Psychometric properties will be measured.

Detailed description

Most of patients with a neurodegenerative disease will develop swallowing impairments (dysphagia) during their disease progression (up to 80%- 100% in Parkinson disease and Amyotrophic Lateral Sclerosis). Dysphagia is associated with serious clinical complications, particularly regarding loss of life quality, insufficient medication intake, malnutrition, dehydration, and aspiration with subsequent pneumonia, which is the leading cause of death in this population. Early detection and measurement of dysphagia trough validated and standardized procedures plays a fundamental role in the clinical practice. Clinical assessment by a speech language pathologist (SLP) can provide early identification of dysphagia and its severity and direct clinical decision making. The English version of the "Clinical Assessment of Dysphagia in Neurodegeneration" (CADN), represents a rapid and valid clinical assessment tool for dysphagia in neurodegenerative population. Currently, there is no validated tool in Italian specific for the clinical assessment of dysphagia in neurodegenerative disease with strong psychometric characteristics. The present study aims to translate and validate the Italian version of CADN in neurodegenerative population. The study will be carried out in two phases: 1. Forward and back translation 2. Validation process

Interventions

OTHERAdministration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

the CADN will be administrated to each patient at the enrolment

Sponsors

Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* diagnosis of neurodegenerative disease according to the respective consensus criteria * \>18 years old * able to provide informed consent * able to follow simple instructions * capable of sitting upright for anamnesis and examination for at least 20 min (in chair or wheelchair)

Exclusion criteria

* history of stroke * surgery to the head or neck * radiotherapy in the last 12 months * dysphagia resulting from other known causes

Design outcomes

Primary

MeasureTime frameDescription
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)at the enrolmentClinical assessment tool administrated by a Speech Language Pathologist. The CADN is composed by a clinical case history and a consumption part for a total of 11 item. Severity scores for each item range from 0 (no impairment) to 4 (severe impairment).

Secondary

MeasureTime frameDescription
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)At the enrolmentInstrumental examination, gold standard for the assessment of dysphagia.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026