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Идёт набор NCT06127459

Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury

Без фазы С лечением Traumatic 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: Parental Guidance, Virtual Reality Game.
Кому может быть актуально
Состояния в реестре: Traumatic Brain Injury. Базовые параметры: 8 лет — 12 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
Финляндия
Следующий шаг
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Официальное название

Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)

Обзор

Traumatic brain injury (TBI) causes lifelong disability. Children with TBI often have difficulties in attention regulation and executive functions affecting their daily living. Need for rehabilitation is often long-lasting and there is an increasing demand for timely, cost-effective, and feasible rehabilitation methods, where the training is targeted to support daily life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations. The aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control, and executive functions by using a virtual environment that corresponds to typical everyday life. In this randomized control study, VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress. The researchers expect that; 1) Intensive training improves the attention regulation, activity control skills, and executive functions of the children in the intervention group 2)Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3)The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.

Вмешательства

  • Поведенческое Parental Guidance
    Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).
  • Поведенческое Virtual Reality Game
    Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.

Первичные конечные точки

  • Epeli (Executive Performance in Everyday LIving) task [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • ADHD-rating scale IV (ADHD-RS) (parent report) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • Epeli Questionnaire (parent report) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • Epeli Questionnaire (child report) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
Вторичные конечные точки (7)
  • Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • Concentration questionnaire (in Finnish: Keskittymiskysely) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • 9. Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • N-back test [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]
  • The Conners Continuous Performance Test 3rd Edition (Conners CPT3) [Срок оценки: Baseline, 4-6 weeks, 6 months and 12 months.]

Критерии участия

Критерии включения

  • Mild to moderate traumatic brain injury (ICD-10: S06.0-S06.6 and S06.8-S06.9 and criteria defined in the Current Care Recommendation, 2021) and
  • The challenges of attention and executive function identified in the assessment of a neuropsychologist/experienced psychologist and
  • Age 8-12 years and
  • Finnish as a native language

Критерии исключения

  • Sensitivity to flashing light,
  • Epilepsy (ICD-10 G40),
  • Mental retardation (ICD-10 F70-F79),
  • Pervasive developmental disorders (ICD-10 F84),
  • Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
  • Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
  • Brain tumour, and
  • Multiple pregnancy

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
Открытое
Основная цель
Лечение

Центры проведения

Финляндия · 1 центр
  • Oulu University Hospital — Oulu

Идентификаторы

NCT: NCT06127459 · 206/ 2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗