Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Motor, cognitive and psychological assessment.
- Кому может быть актуально
- Состояния в реестре: Ictus, Severe Acquired Brain Injury, sABI. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
Обзор
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke. The secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.
Подробное описание
Participants included in the study will undergo cognitive, motor, psychological, behavioral, personality, and disability assessments at different time points following the neurological event:
T0: Initial assessment upon admission to the rehabilitation facility; within 90 days of the event for patients with severe acquired brain injury (sABI), as soon as cognitive evaluation becomes feasible (LCF ≥ 6); within 30 days of the event for stroke patients, as soon as cognitive assessment is possible.
T1: At discharge from the inpatient rehabilitation program, provided that at least 30 days have passed since the initial assessment (T0).
T2: At 12 months post-event for stroke patients and at 18 months post-event for patients with ABI.
Вмешательства
- Диагностический тест Motor, cognitive and psychological assessment
Participants evaluated at T0 (Initial assessment upon admission to the rehabilitation facility), T1 (at discharge from the inpatient rehabilitation program, as long as at least 30 days have passed since the initial assessment (T0), T2 (at 12 months from the event for patients with stroke, and at 18 months from the event for patients with sABI).
Первичные конечные точки
- Montreal Cognitive Assessment (MoCA) [Срок оценки: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).]
Вторичные конечные точки (12)
- Oxford Cognitive Screen (OCS) [Срок оценки: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).]
- Trial Making Test (TMT) [Срок оценки: The test is administered (both stroke and sABI) at baseline -T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).]
- Digit Span Forward [Срок оценки: The test is administered (both stroke and sABI at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Corsi Span Forward [Срок оценки: The test is administered (both stroke and sABI)at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Digit Span Backward [Срок оценки: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Corsi span backward [Срок оценки: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Rey Auditory Verbal Learning Test (RAVLT) [Срок оценки: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Test della Figura di Rey - Test della Figura di Taylor [Срок оценки: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).]
- Stroop Test (ST) [Срок оценки: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).]
- Modified Five Point Test (MFPT) [Срок оценки: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).]
- Phonemic fluency [Срок оценки: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).]
- Semantic fluency [Срок оценки: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).]
Критерии участия
Критерии включения
- diagnosis of one of the following two conditions:
- Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and/or behavioral impairments.
- Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale \[GCS\] score ≥ 8 and no alteration of consciousness).
- Time from injury between:
- 7 and 90 days for Severe Acquired Brain Injury (sABI) patients
- 3 and 30 days for stroke patients
- Level of Cognitive Functioning (LCF) score ≥ 6 for sABI patients
- Signed informed consent for study participation
- Presence of a support family member (caregiver) able to assist with completing the personality questionnaire (HEXACO Adjective Scale, HAS)
Критерии исключения
- Pre-existing neurological pathology
- Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.
- Patients with a language barrier due to insufficient proficiency in Italian.
- Particularly vulnerable populations:
The following patients will be excluded from the study: patients in emergency situations.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona — Verona
Идентификаторы
NCT: NCT07119827 · 481CET