Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
研究概览
简要总结
Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.
详细描述
The aim of the study is to develop and validate quantitative interactive attention evaluation criteria by using games on touchscreen and or eye tracking in patients with intellectual disability. Tests will have to be suitable whatever severity and etiology of intellectual disability. Tests have to evaluate attention and concentration troubles in intellectual disability.Once validated, tests could be used as outcome measures in clinical trials and as cognitive reeducation tools in intellectual disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sex, with intellectual disability
- •Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients
- •Patients with more or less severe intellectual disability from various causes including Fragile X syndrome, Rett syndrome, Angelman syndrome and other etiologies of intellectual disabilities and intellectual disabilities without identified etiology
- •Affiliation to a social security system own or affiliated (excluding AME)
- •Presence of parents or legal representative
- •Informed consent signed by parents or legal representative
排除标准
- •Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
- •Uncontrolled seizure disorder despite treatment
结局指标
主要结局
Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
时间窗: up to 3 months
Test performed 1 time during a visit (1 day) can be repeated (for a maximum of 15 patients) within 3 months if an adaptation of the interactive tool is necessary
次要结局
- Time to reach maximum level of the test(up to 3 months)
- Total test duration(up to 3 months)
- Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity(up to 3 months)
- Maximal reached level for each test(up to 3 months)
- Time to reach each level of the test(up to 3 months)
- Successful test numbers in each level(up to 3 months)
- Number of errors during the test(up to 3 months)
- Fixing time for eye tracking(up to 3 months)