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NCT07711119

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

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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