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

Last updated: January 31, 2025
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Achalasia

Heartburn

Treatment

Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Clinical Study ID

NCT05733494
CE2622
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of neurodegenerative disease according to the respective consensuscriteria

  • >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 (inchair or wheelchair)

Exclusion

Exclusion Criteria:

  • history of stroke

  • surgery to the head or neck

  • radiotherapy in the last 12 months

  • dysphagia resulting from other known causes

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Phase:
Study Start date:
April 05, 2022
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • Istituti Clinici Scientifici Maugeri

    Milan, Milano 20138
    Italy

    Active - Recruiting

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