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

February 26, 2026 updated by: Micol Castellari, Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Milan, Milano, Italy, 20138
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with neurodegenerative disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with neurodegenerative disease
Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
the CADN will be administrated to each patient at the enrolment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Time Frame: at the enrolment
Clinical 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).
at the enrolment
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Time Frame: at 24 hours from enrolment
Clinical 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).
at 24 hours from enrolment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
Time Frame: At the enrolment
Instrumental examination, gold standard for the assessment of dysphagia.
At the enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Actual)

February 16, 2026

Study Completion (Actual)

February 16, 2026

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE2622

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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