Виртуальная реальность в реабилитации исполнительных функций у детей с синдромом дефицита внимания и гиперактивности. (VREALFUN-ADHD)
Виртуальная реальность в реабилитации исполнительных функций у детей (VREALFUN)
Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday 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 major 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 the virtual environment that corresponds to the 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.
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.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Merja Nikula, M.Psych.
- Номер телефона: +3588315 5218
- Электронная почта: merja.nikula@pohde.fi
Учебное резервное копирование контактов
- Имя: Johanna Uusimaa, MD, PhD
- Электронная почта: johanna.uusimaa@pohde.fi
Места учебы
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Oulu, Финляндия, 90029
- Рекрутинг
- Oulu University Hospital
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Контакт:
- Johanna Uusimaa, MD, PhD
- Электронная почта: johanna.uusimaa@pohde.fi
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Контакт:
- Merja Nikula, M.Psych.
- Электронная почта: merja.nikula@pohde.fi
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Главный следователь:
- Merja Nikula, M.Psych.
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Младший исследователь:
- Johanna Uusimaa, MD, PhD
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Младший исследователь:
- Mirjami Mäntymaa, MD, PhD
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Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosis of ADHD (ICD-10 F90.0) and
- Methylphenidate medication and
- Age 8-12 years and
- Finnish as a native language
Exclusion Criteria:
- 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),
- Traumatic brain injury ((ICD-10 S06),
- Brain tumour, and
- Multiple pregnancy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
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Экспериментальный: Родительский контроль + игра в виртуальной реальности
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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) .
Другие имена:
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. |
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Экспериментальный: Родительское воспитание
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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) .
Другие имена:
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Экспериментальный: Игра виртуальной реальности
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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. |
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Без вмешательства: Control Group
This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Epeli (Executive Performance in Everyday LIving) task
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action. |
Baseline, 4-6 weeks, 6 months and 12 months.
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ADHD-rating scale IV (ADHD-RS) (parent report)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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The ADHD-RS (parent report) is an assessment of a child's ADHD symptoms with 18 items based on the child's behaviour over the past 6 months. 4-point Likert scale. The total score ranges 0-54, scores in inattention subscale and hyperactivity/impulsivity subscale range 0-27. Change in the total score, inattention subscale score, and hyperactivity/impulsivity subscale score on a parent-rated ADHD-RS. A lower score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
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Epeli Questionnaire (parent report)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on parent-rated Epeli- questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
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Epeli Questionnaire (child report)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on child-rated Epeli- questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the parent. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on parent-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
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Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
|
A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the teacher. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on teacher-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
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Concentration questionnaire (in Finnish: Keskittymiskysely)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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An assessment of attention and executive function difficulties in school-aged children with 55 items. 3-point Likert Scale, Total score range 0-110. Change in Total score, Distractibility score (range 0-8), sum of Impulsivity and Motor hyperactivity subscales scores (range 0-32), sum of Directing, Sustaining and Shifting Attention subscales scores (range 0-30), and sum of Initiative, Planning, Execution and Evaluation of Action subscales scores (range 0-40) on teacher-rated Concentration questionnaire. In case the data in the Distractibility subscale, Impulsivity and Motor hyperactivity subscales, Attention subscales and Executive subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on Concentration questionnaire Total score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score implies a worse outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
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Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on parent-rated questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
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Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
|
An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on child-rated questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
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N-back test
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
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A test for a working memory. Change in 2-back and 1-back hitrate and reaction time. |
Baseline, 4-6 weeks, 6 months and 12 months.
|
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The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
Временное ограничение: Baseline, 4-6 weeks, 6 months and 12 months.
|
A computerized attention task validated in individuals aged 8 years and older. Change in scores on Conners Continuous Performance Test (CPT-3). |
Baseline, 4-6 weeks, 6 months and 12 months.
|
Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Учебный стул: Johanna Uusimaa, MD, PhD, Oulu University Hospital
- Главный следователь: Merja Nikula, M.Psych., Oulu University Hospital
- Директор по исследованиям: Mirjami Mäntymaa, MD, PhD, Oulu University Hospital
- Директор по исследованиям: Juha Salmitaival, PhD, University of Oulu, Finland
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- 206/2021
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .