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 | Not Yet Recruiting

• 1 other identifier: BERA-SWADOC
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

disorders of consciousness; severe acquired brain injury; BERA; Brief Evaluation of Receptive Aphasia; SWADOC; swallowing assessment; Receptive Aphasia; rehabilitation

Outcome Measures

Primary Outcomes (4)

• Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score

  Inter-rater reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The SWADOC quantitative scoring system includes 8 scored items rated from 0 to 3, allowing calculation of oral and pharyngeal subscores and a total score.

  Day 1, during the first assessment session

• Test-retest reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score

  Test-retest reliability will be assessed for the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.

  Baseline and approximately 24 hours later

• Inter-rater reliability of the Italian Brief Evaluation of Receptive Aphasia total score

  Inter-rater reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient for agreement between independent raters. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater inter-rater reliability. The BERA includes 30 items per version, with 10 phonological, 10 semantic, and 10 morphosyntactic items; each correct visual fixation response is scored as 1 point and errors or absent fixation as 0 points.

  Day 1, during the first assessment session

• Test-retest reliability of the Italian Brief Evaluation of Receptive Aphasia total score

  Test-retest reliability will be assessed for the total score of the Italian version of the Brief Evaluation of Receptive Aphasia in the eligible subgroup of patients. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The reported outcome will be the intraclass correlation coefficient between the baseline assessment and the reassessment performed approximately 24 hours later. The intraclass correlation coefficient is a unitless reliability coefficient ranging from 0 to 1, with higher values indicating greater test-retest reliability.

  Baseline and approximately 24 hours later

Secondary Outcomes (2)

• Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score

  Baseline/Day 1

• Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score

  Baseline/Day 1

Study Arms (1)

Patients with severe acquired brain injury and disorders of consciousness

Consecutive adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness admitted to one of the four participating centers and meeting eligibility criteria. All eligible participants will undergo SWADOC validation assessments. A nested subgroup of the first 22 participants who also meet BERA-specific criteria will undergo BERA validation assessments.

Diagnostic Test: Italian SWallowing Assessment in Disorders of Consciousness (SWADOC); Diagnostic Test: Italian Brief Evaluation of Receptive Aphasia (BERA)

Interventions

Italian SWallowing Assessment in Disorders of Consciousness (SWADOC) DIAGNOSTIC_TEST

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.

Patients with severe acquired brain injury and disorders of consciousness

Italian Brief Evaluation of Receptive Aphasia (BERA) DIAGNOSTIC_TEST

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.

Patients with severe acquired brain injury and disorders of consciousness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult inpatients with severe acquired brain injury and a stable diagnosis of disorder of consciousness consecutively admitted to the four participating Italian rehabilitation/neurorehabilitation centers and meeting the inclusion/exclusion criteria.

You may qualify if:

• Age \>= 18 years.
• Native Italian speaker.
• Diagnosis of severe acquired brain injury.
• At least 28 days since the acute event.
• For SWADOC validation: stable clinical diagnosis of disorder of consciousness, including UWS, MCS, or EMCS, assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.
• For BERA validation: stable clinical diagnosis of MCS or EMCS assessed with the Coma Recovery Scale-Revised repeated at least five times over two weeks.
• For BERA validation: presence of visual fixation and/or visual pursuit assessed with the Coma Recovery Scale-Revised.
• No remote history of neurological, neurodegenerative, or psychiatric disease; for SWADOC validation, no remote history of otorhinolaryngological disease.
• Written informed consent provided by the primary caregiver/legal representative according to local regulations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alfonso Magliacano: lead
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator

Study Sites (4)

Polo Specialistico Riabilitativo Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, AV, 83054, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy

Location

IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

Location

IRCCS SM Nascente Fondazione Don Carlo Gnocchi

Milan, Italy

Location

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries; Aphasia, Wernicke

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Aphasia; Speech Disorders; Language Disorders; Communication Disorders

Study Officials

• Alfonso Magliacano, PhD

  Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Magliacano, PhD

CONTACT

393387389414; amagliacano@dongnocchi.it

Anna Estraneo, MD

CONTACT

aestraneo@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

IT (4)