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

NCT ID: NCT05733494

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-05

Study Completion Date

2025-12-31

Brief Summary

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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

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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

Conditions

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Swallowing Disorder Dysphagia Neuro-Degenerative Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with neurodegenerative disease

Patients with neurodegenerative disease

Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

Intervention Type OTHER

the CADN will be administrated to each patient at the enrolment

Interventions

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Administration of Clinical Assessment of Dysphagia in Neurodegeneration (CADN)

the CADN will be administrated to each patient at the enrolment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role lead

Responsible Party

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Micol Castellari

Speech-Language Pathologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituti Clinici Scientifici Maugeri

Milan, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Micol Castellari, Speech-Language Pathologist

Role: CONTACT

3392234850 ext. + 39

Facility Contacts

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Micol Castellari

Role: primary

+ 39 3392234850

Other Identifiers

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CE2622

Identifier Type: -

Identifier Source: org_study_id

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