Clinical trial NCT05733494: Cross Cultural Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration
Official title: Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Swallowing Disorder
Dysphagia
Neuro-Degenerative Disease
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with neurodegenerative disease

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
timeFrame: at the enrolment
measure: Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
timeFrame: at 24 hours from enrolment
Secondary outcomes:
measure: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
timeFrame: At the enrolment
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Milano
Study officials:
References: