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

• Sponsor: Istituti Clinici Scientifici Maugeri SpA (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05733494
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Anticipated Duration (Months): 31.9
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Swallowing Disorder; Dysphagia; Neuro-Degenerative Disease	Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 101 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
• Actual Study Start Date: Apr 5, 2022
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with neurodegenerative disease Patients with neurodegenerative disease	Other: Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN); the CADN will be administrated to each patient at the enrolment

Outcome Measures

Primary Outcome Measures

1. Clinical Assessment of Dysphagia in Neurodegeneration (CADN) [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).

2. Clinical Assessment of Dysphagia in Neurodegeneration (CADN) [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).

Secondary Outcome Measures

1. Fiberoptic Endoscopic Evaluation of Swallowing (FEES) [At the enrolment]

   Instrumental examination, gold standard for the assessment of dysphagia.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituti Clinici Scientifici Maugeri	Milan	Milano	Italy	20138

Sponsors and Collaborators

• Istituti Clinici Scientifici Maugeri SpA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Micol Castellari, Speech-Language Pathologist, Istituti Clinici Scientifici Maugeri SpA
• ClinicalTrials.gov Identifier: NCT05733494
• Other Study ID Numbers: CE2622
• First Posted: Feb 17, 2023
• Last Update Posted: Feb 17, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Deglutition Disorders; Neurodegenerative Diseases; Nerve Degeneration

Study Results

No Results Posted as of Feb 17, 2023