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Completed

NCT Number: NCT05733494

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri

Milan, Milano, 20138, Italy

About this study

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:

  • Forward and back translation
  • Validation process

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Other

the CADN will be administrated to each patient at the enrolment

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

    Time frame: At the enrolment

    Instrumental examination, gold standard for the assessment of dysphagia.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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