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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)

14. července 2026 aktualizováno: Alfonso Magliacano

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)

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This study is part of the Horizon MSCA DoC-Box project, which aims to develop a multimodal toolbox to support fast and reliable diagnosis of disorders of consciousness. The study includes two consecutive phases. In Phase 1, the original French versions of BERA and SWADOC will be translated into Italian by two expert translators. The translated versions will be synthesized, back-translated into the original language by two independent blinded translators, compared, discussed, and revised by researchers and experts according to international guidelines for translation and cultural adaptation. In Phase 2, the Italian versions will be evaluated in a multicenter observational validation study involving three Fondazione Don Carlo Gnocchi centers (Sant'Angelo dei Lombardi, Florence, Milan) and the IRCCS Istituto Neurologico Carlo Besta in Milan. After diagnostic confirmation based on repeated CRS-R assessments, Examiner A will administer the SECONDs to assess the level of consciousness. On the same day, Examiner B will administer the Italian BERA and/or SWADOC, while Examiner C will independently score the scales to assess inter-rater agreement. After approximately 24 hours, Examiner A will repeat the SECONDs, and either Examiner B or Examiner C will repeat BERA and/or SWADOC to assess test-retest reliability. Demographic and clinical variables, level of consciousness, total scores, and subscale scores will be entered in a centralized pseudonymized REDCap database and analyzed in aggregate form.

Typ studie

Pozorovací

Zápis (Odhadovaný)

79

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Itálie
      • Florence, Itálie
        • IRCCS Fondazione Don Carlo Gnocchi
        • Kontakt:
      • Milan, Itálie
      • Milan, Itálie
        • IRCCS SM Nascente Fondazione Don Carlo Gnocchi
        • Kontakt:
    • AV
      • Sant'Angelo dei Lombardi, AV, Itálie, 83054
        • Polo Specialistico Riabilitativo Fondazione Don Gnocchi
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Diagnostický 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.
Diagnostický 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
Časové okno: Day 1, during the first assessment session
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
Časové okno: Baseline and approximately 24 hours later
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
Časové okno: Day 1, during the first assessment session
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
Časové okno: Baseline and approximately 24 hours later
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score
Časové okno: Baseline/Day 1
Convergent validity will be assessed by calculating the Spearman rank correlation coefficient between the total score of the Italian version of the Swallowing Assessment in Disorders of Consciousness and the total score of the Coma Recovery Scale-Revised. The SWADOC total score ranges from 0 to 24, with higher scores indicating better preserved swallowing abilities. The Coma Recovery Scale-Revised total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness. The reported outcome will be Spearman's rho, a unitless correlation coefficient ranging from -1 to +1.
Baseline/Day 1
Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score
Časové okno: Baseline/Day 1
Convergent validity will be assessed by calculating the Spearman rank correlation coefficient between the total score of the Italian version of the Brief Evaluation of Receptive Aphasia and the total score of the Coma Recovery Scale-Revised. The BERA total score ranges from 0 to 30, with higher scores indicating better receptive language abilities. The Coma Recovery Scale-Revised total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness. The reported outcome will be Spearman's rho, a unitless correlation coefficient ranging from -1 to +1.
Baseline/Day 1

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alfonso Magliacano

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: Alfonso Magliacano, PhD, Fondazione Don Carlo Gnocchi

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

31. srpna 2028

Dokončení studie (Odhadovaný)

31. srpna 2028

Termíny zápisu do studia

První předloženo

9. července 2026

První předloženo, které splnilo kritéria kontroly kvality

14. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BERA-SWADOC

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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