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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733494
• Other study ID #: CE2622
• Status: Recruiting
• Start date: April 5, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Micol Castellari, Speech-Language Pathologist
• Phone: 3392234850
• Email: micol.castellari[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 101
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Nerve Degeneration
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Swallowing Disorder

Intervention

Other:
• Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
the CADN will be administrated to each patient at the enrolment

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Assessment of Dysphagia in Neurodegeneration (CADN)	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
Primary	Clinical Assessment of Dysphagia in Neurodegeneration (CADN)	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	Fiberoptic Endoscopic Evaluation of Swallowing (FEES)	Instrumental examination, gold standard for the assessment of dysphagia.	At the enrolment