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

NCT05733494 | Completed

• 1 other identifier: CE2622
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Swallowing Disorder; Dysphagia; Neuro-Degenerative Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

  At the enrolment

Study Arms (1)

Patients with neurodegenerative disease

Patients with neurodegenerative disease

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

Interventions

Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN) OTHER

the CADN will be administrated to each patient at the enrolment

Patients with neurodegenerative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with neurodegenerative disease

You may qualify if:

• 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)

You may not qualify if:

• history of stroke
• surgery to the head or neck
• radiotherapy in the last 12 months
• dysphagia resulting from other known causes

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, Milano, 20138, Italy

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speech-Language Pathologist

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 17, 2023
• Study Start: April 5, 2022
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

IT (1)