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)
2026年7月14日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
観察的
入学 (推定)
79
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Anna Estraneo, MD
- メール：aestraneo@dongnocchi.it
研究連絡先のバックアップ
- 名前：Alfonso Magliacano, PhD
- 電話番号：393387389414
- メール：amagliacano@dongnocchi.it
研究場所
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Florence、イタリア
- IRCCS Fondazione Don Carlo Gnocchi
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コンタクト：
- Bahia Hakiki
- 電話番号：3905573931
- メール：bhakiki@dongnocchi.it
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Milan、イタリア
- IRCCS Istituto Neurologico Carlo Besta
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コンタクト：
- Matilde Leonardi
- 電話番号：390223941
- メール：Matilde.Leonardi@istituto-besta.it
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Milan、イタリア
- IRCCS SM Nascente Fondazione Don Carlo Gnocchi
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コンタクト：
- Angela Comanducci
- 電話番号：3902403081
- メール：acomanducci@dongnocchi.it
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AV
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Sant'Angelo dei Lombardi、AV、イタリア、83054
- Polo Specialistico Riabilitativo Fondazione Don Gnocchi
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コンタクト：
- Alfonso Magliacano
- 電話番号：393387389414
- メール：amagliacano@dongnocchi.it
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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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.
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Inter-rater reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
時間枠：Day 1, during the first assessment session
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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.
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Day 1, during the first assessment session
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Test-retest reliability of the Italian Swallowing Assessment in Disorders of Consciousness total score
時間枠：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
|
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Inter-rater reliability of the Italian Brief Evaluation of Receptive Aphasia total score
時間枠：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.
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Day 1, during the first assessment session
|
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Test-retest reliability of the Italian Brief Evaluation of Receptive Aphasia total score
時間枠：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.
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Baseline and approximately 24 hours later
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Convergent validity of the Italian Swallowing Assessment in Disorders of Consciousness total score with the Coma Recovery Scale-Revised total score
時間枠：Baseline/Day 1
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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.
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Baseline/Day 1
|
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Convergent validity of the Italian Brief Evaluation of Receptive Aphasia total score with the Coma Recovery Scale-Revised total score
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alfonso Magliacano, PhD、Fondazione Don Carlo Gnocchi
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年7月9日
QC基準を満たした最初の提出物
2026年7月14日
最初の投稿 (実際)
2026年7月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- BERA-SWADOC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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