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Cross-cultural Adaptation and Multicenter Validation of the Italian Versions of the Brief Evaluation of Receptive Aphasia (BERA) and SWallowing Assessment in Disorders of Consciousness (SWADOC)
Sponsor: Alfonso Magliacano
Summary
Patients with severe acquired brain injury may evolve from coma into prolonged disorders of consciousness. In these patients, residual language comprehension and swallowing abilities are difficult to evaluate because standard assessments often depend on verbal or motor responses. The Brief Evaluation of Receptive Aphasia (BERA) assesses receptive language abilities through visual/eye-movement responses, whereas the SWallowing Assessment in Disorders of Consciousness (SWADOC) assesses oral and pharyngeal components of swallowing in patients with disorders of consciousness. This national multicenter observational study aims to perform the Italian cross-cultural adaptation and validation of BERA and SWADOC. Consecutive adult inpatients with severe acquired brain injury and disorders of consciousness will be recruited from four Italian centers. SWADOC will be administered to 57 patients, and BERA will be administered to a nested subgroup of 22 patients who meet additional criteria. Inter-rater reliability, test-retest reliability over 24 hours, and convergent validity with Coma Recovery Scale-Revised scores will be analyzed.
Official title: Adattamento Trans-culturale e Validazione Multicentrica Della Versione Italiana Delle Scale Brief Evaluation of Receptive Aphasia (BERA) e SWallowing Assessment in Disorders of Consciousness (SWADOC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
79
Start Date
2026-09-01
Completion Date
2028-08-31
Last Updated
2026-07-17
Healthy Volunteers
No
Interventions
Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)
Structured clinical assessment of oral and pharyngeal swallowing components in patients with disorders of consciousness. The Italian version will be administered and scored by trained examiners to evaluate inter-rater and test-retest reliability.
Italian Brief Evaluation of Receptive Aphasia (BERA)
Brief clinical assessment of receptive language abilities, including phonology, semantics, and morphosyntax. Responses are based on visual/eye-movement behavior, allowing assessment of patients unable to communicate verbally or through reliable motor responses. It will be administered to the nested subgroup meeting BERA-specific criteria.
Locations (4)
Polo Specialistico Riabilitativo Fondazione Don Gnocchi
Sant'Angelo dei Lombardi, AV, Italy
IRCCS Fondazione Don Carlo Gnocchi
Florence, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
IRCCS SM Nascente Fondazione Don Carlo Gnocchi
Milan, Italy