Validation of an Italian tool for assessing swallowing disorders in neurodegenerative diseases
Cross-Cultural Adaptation and Validation of the Italian Version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN)
Istituti Clinici Scientifici Maugeri SpA · NCT05733494
This study is testing a new Italian tool to help doctors better identify and manage swallowing problems in people with neurodegenerative diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA (other) |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT05733494 on ClinicalTrials.gov |
What this trial studies
This study aims to translate and validate the Italian version of the Clinical Assessment of Dysphagia in Neurodegeneration (CADN), a tool designed to assess swallowing disorders in patients with neurodegenerative diseases. The study will involve a two-phase process: first, forward and back translation of the assessment tool, followed by a validation process to ensure its psychometric properties are robust. By establishing a validated tool in Italian, the study seeks to enhance early detection and management of dysphagia in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with a neurodegenerative disease who can provide informed consent and follow simple instructions.
Not a fit: Patients with a history of stroke, head or neck surgery, recent radiotherapy, or dysphagia from other known causes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable assessment tool for early detection of dysphagia, improving patient care and outcomes in neurodegenerative diseases.
How similar studies have performed: While the English version of the CADN has shown success, this specific validation for the Italian population is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, Milano
- Istituti Clinici Scientifici Maugeri — Milan, Milano, Italy (RECRUITING)
Study contacts
- Study coordinator: Micol Castellari, Speech-Language Pathologist
- Email: micol.castellari@icsmaugeri.it
- Phone: 3392234850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Swallowing Disorder, Dysphagia, Neuro-Degenerative Disease