Cross Cultural Validation of the Italian Version of the Clinical

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05733494
Study type	Observational
Source	Istituti Clinici Scientifici Maugeri SpA
Contact	Micol Castellari, Speech-Language Pathologist
Phone	3392234850
Email	micol.castellari@icsmaugeri.it
Status	Recruiting
Phase
Start date	April 5, 2022
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms