虚拟现实在注意力缺陷多动障碍儿童执行功能康复中的应用。 (VREALFUN-ADHD)
虚拟现实在儿童执行功能康复中的应用 (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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Merja Nikula, M.Psych.
- 电话号码：+3588315 5218
- 邮箱：merja.nikula@pohde.fi
研究联系人备份
- 姓名：Johanna Uusimaa, MD, PhD
- 邮箱：johanna.uusimaa@pohde.fi
学习地点
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Oulu、芬兰、90029
- 招聘中
- Oulu University Hospital
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接触：
- Johanna Uusimaa, MD, PhD
- 邮箱：johanna.uusimaa@pohde.fi
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接触：
- Merja Nikula, M.Psych.
- 邮箱：merja.nikula@pohde.fi
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首席研究员：
- Merja Nikula, M.Psych.
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副研究员：
- Johanna Uusimaa, MD, PhD
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副研究员：
- Mirjami Mäntymaa, MD, PhD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：家长指导+虚拟现实游戏
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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) .
其他名称：
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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实验性的：父母的引导和规范
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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) .
其他名称：
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实验性的：虚拟现实游戏
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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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无干预：Control Group
This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Epeli (Executive Performance in Everyday LIving) task
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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 child-rated Epeli- questionnaire. A higher score means a better outcome. |
Baseline, 4-6 weeks, 6 months and 12 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
大体时间：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)
大体时间：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 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)
大体时间：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)
大体时间：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)
大体时间：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 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
大体时间：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)
大体时间：Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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合作者和调查者
赞助
调查人员
- 学习椅：Johanna Uusimaa, MD, PhD、Oulu University Hospital
- 首席研究员：Merja Nikula, M.Psych.、Oulu University Hospital
- 研究主任：Mirjami Mäntymaa, MD, PhD、Oulu University Hospital
- 研究主任：Juha Salmitaival, PhD、University of Oulu, Finland
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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