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Clinical Trials/NCT05733494
NCT05733494
Completed
N/A

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

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country101 target enrollmentApril 5, 2022

Overview

Phase
N/A
Intervention
Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Conditions
Swallowing Disorder
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
101
Locations
1
Primary Endpoint
Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Status
Completed
Last Updated
2 months ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 5, 2022
End Date
February 16, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Micol Castellari

Speech-Language Pathologist

Istituti Clinici Scientifici Maugeri SpA

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

Arms & Interventions

Patients with neurodegenerative disease

Patients with neurodegenerative disease

Intervention: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • Fiberoptic Endoscopic Evaluation of Swallowing (FEES)(At the enrolment)

Study Sites (1)

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