Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Epeli (Executive Performance in Everyday LIving) task
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Epeli (Executive Performance in Everyday LIving) task
时间窗: Baseline, 4-6 weeks, 6 months and 12 months.
A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action.
Epeli Questionnaire (parent report)
时间窗: 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 parent-rated Epeli- questionnaire. A higher score means a better outcome.
Epeli Questionnaire (child report)
时间窗: 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.
ADHD-rating scale IV (ADHD-RS) (parent report)
时间窗: Baseline, 4-6 weeks, 6 months and 12 months.
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.
次要结局
- Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)(Baseline, 4-6 weeks, 6 months and 12 months.)
- N-back test(Baseline, 4-6 weeks, 6 months and 12 months.)
- Concentration questionnaire (in Finnish: Keskittymiskysely)(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)(Baseline, 4-6 weeks, 6 months and 12 months.)
- The Conners Continuous Performance Test 3rd Edition (Conners CPT3)(Baseline, 4-6 weeks, 6 months and 12 months.)
- Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)(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)(Baseline, 4-6 weeks, 6 months and 12 months.)
研究者
Merja Nikula
Principal investigator
Oulu University Hospital