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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)

NCT07711119 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

  • Consciousness Disorders
  • Severe Acquired Brain Injury

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Alfonso Magliacano

    lead OTHER

Principal Investigators

  • Alfonso Magliacano, PhD · Fondazione Don Carlo Gnocchi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07711119 on ClinicalTrials.gov