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)
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
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:
- Forward and back translation
- Validation process
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Milano
-
Milan, Milano, Italy, 20138
- Istituti Clinici Scientifici Maugeri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with neurodegenerative disease
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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