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)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlfonso Magliacano

About this trial

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.

Eligibility criteria

Qualifiers

Age >= 18 years.

Native Italian speaker.

Diagnosis of severe acquired brain injury.

At least 28 days since the acute event.

Disqualifiers

Occurrence of a second cerebral event between enrollment and data collection.

Unstable general clinical condition preventing assessment, including but not limited to need for ventilatory support, severe infection, or status epilepticus.

Trial design

Treatments tested in this trial

  • Italian SWallowing Assessment in Disorders of Consciousness (SWADOC)
  • Italian Brief Evaluation of Receptive Aphasia (BERA)

Treatment groups

79 Participants
are divided into 1 treatment group

Sponsors and collaborators

Alfonso Magliacano

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Sponsor institution

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborator