Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Average number of commission errors
研究概览
简要总结
The aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in conditions closer to reality
详细描述
Attention Deficit Hyperactivity Disorder (ADHD) is the most common neurodevelopmental disorder in school-aged children. This disorder is characterized by a symptomatic triad associating, inattention, hyperactivity and impulsivity. Cognitive, emotional and behavioral dysfunctions have a strong impact on the school, family and social domains of the child. The clinical diagnosis of ADHD is all the more difficult because there are currently no biological, clinical or psychological markers that accurately measure the symptoms of ADHD. The diagnosis is made during interviews with specialist doctors allowing the collection of information from parents and the child. Virtual reality technology is most recognized as a tool for assessment, rehabilitation of cognitive processes and functional skills. In addition to traditional diagnostic assessment methods, a virtual reality application in an immersive room (CAVE) in three dimensions could objectively assess the child in a dynamic environment that is as close as possible to everyday situations
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Group of children with ADHD :
- •Children aged 8 to 12 diagnosed with ADHD (according to DSM-V criteria)
- •Positive ADHD diagnosis with standardized maintenance of Kiddie-Sads
- •Naïve drug treatment for ADHD
- •Schooled in a classic environment
- •Intellectual Quotient> 80 (4 subtests of WASI, or WISC IV-R / WISC-V less than 2 years old)
- •Having French as mother tongue
- •Children benefiting from a social security scheme
- •Signing of free, informed and written consent by the child and the holders of parental authority Group of children controls
- •Children aged 8 to 12 years undiagnosed ADHD (according to DSM-V criteria) :
- •Not presenting with ADHD at standardized maintenance Kiddie-Sads
- •Schooled in a classic environment
- •Intellectual Quotient> 80 (4 subtests of WASI)
- •Having French as mother tongue
- •Children benefiting from a social security scheme
- •Signing of free, informed and written consent by the child and the holders of parental authority
排除标准
- •Positive diagnosis with standardized maintenance of Kiddie-Sads for the following disorders: mood disorders, psychotic disorders, autism spectrum disorders, severe anxiety disorders and severe tic disorders
- •Presenting a hearing or vision diagnosis diagnosed that does not allow the task to be performed in virtual reality
- •Neurological disorders
- •Photosensitive Epilepsy (contraindication to immersion in virtual reality)
- •Treatment with psychostimulants or other psychotropic drugs
- •Unable to complete the virtual reality task during the familiarization session
研究组 & 干预措施
Attention Deficit Hyperactivity Disorder (ADHD)
Children aged 8 to 12 diagnosed with ADHD
干预措施: Virtual reality task (Procedure)
Control
Control group of healthy ADHD children matched in age, gender and laterality to children in ADHD group
干预措施: Virtual reality task (Procedure)
结局指标
主要结局
Average number of commission errors
时间窗: From one day to 8 weeks after day 0
Average number of commission errors to the virtual reality task
次要结局
- Average reaction time (ms)(Day 0)
- Average number of omission errors(Day 0)
- Average number of head movement(From one day to 8 weeks after day 0)
- Average number of foot movement(From one day to 8 weeks after day 0)
- Percentage(From one day to 8 weeks after day 0)
- Percentage of period with presence of Emotion(From one day to 8 weeks after day 0)
- Mean Emotion intensity (Engagement)(From one day to 8 weeks after day 0)
- Mean Emotion valence(From one day to 8 weeks after day 0)
- Average number of commission errors(Day 0)
- Total score with the Attention-Deficit Hyperactivity Disorder-Rating Scale.(Day 0)
- Inattention score with the Attention-Deficit Hyperactivity Disorder-Rating Scale(Day 0)
- Hyperactivity score with the Attention-Deficit Hyperactivity Disorder-Rating Scale(Day 0)
- Executive Performance Inventory Score(Day 0)
- Quality of life (VSPA-e) score(Day 0)
- Quality of life (KIDSCREEN) score(Day 0)
- Acceptability score of virtual reality tool(From one day to 8 weeks after day 0)
- Acceptability score of classic neuropsychological test(From one day to 8 weeks after day 0)
- Simulator Sickness score(From one day to 8 weeks after day 0)
- Feeling of presence score(From one day to 8 weeks after day 0)