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Идёт набор NCT04025398

A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability

Без фазы С лечением Intellectual Disability

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: Cognitive remediation program, Control group.
Кому может быть актуально
Состояния в реестре: Intellectual Disability. Базовые параметры: 18 лет — 45 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
Франция
Следующий шаг
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Официальное название

REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders

Обзор

Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning

Подробное описание

Réhabilitus is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among adults with intellectual disabilities. The main objective is to validate the effectiveness of Réhabilitus program on behavioral disorders in adults with intellectual disabilities without autism spectrum disorder associated.

Вмешательства

  • Поведенческое Cognitive remediation program
    Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
  • Поведенческое Control group
    Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

Первичные конечные точки

  • Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • This measure is repeated at the end of the intervention to highlight the impact of the " Cognitus and Me " program, and 6 months later to investigate the possible long-lasting effects of the benefits [Срок оценки: 6 months]
  • Change from baseline in facial emotion recognition task [Срок оценки: 6 months]
  • Change from baseline in attentional functions [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Adults aged 18 to 45 inclusive;
  • Behavioral disorders corresponding to a total score on the ABC scale > 15
  • Presence of a family caregiver (parent, friend) or professional (reeducator, professional of the medico-social sector) stakeholder of the project;
  • Diagnosis of mild to moderate intellectual disability (assessed by WAIS-IV battery and VABS-II less than 3 years ago;
  • French or secondary mother tongue;
  • Psychoactive treatment unchanged during the month prior to inclusion;
  • Adult or legal representative who has given written and informed consent to participate in the study. By default, the adult's oral agreement will be collected (as well as the written consent of the legal representative);
  • Affiliation to the social security scheme or beneficiary of such a scheme.

Критерии исключения

  • Neurological disorders of vascular, infectious or neurodegenerative origin;
  • Taking medications for general medical purposes with a neurological or psychiatric impact (eg corticosteroids);
  • Simultaneous participation in any other cognitive remediation program targeting attentional, visuospatial and social cognition;
  • Refusal of participation of the person and/or his/her legal representative;
  • Not family or professional caregiver;
  • Presence of Autistic Spectrum Disorders (evaluated by ADOS and ADI if necessary according to the assessment of the investigator)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 1 центр
  • Hopital Vinatier — Lyon

Идентификаторы

NCT: NCT04025398 · 2019-A00179-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗