NCT05122923Unknown不适用
Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A
研究概览
简要总结
This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •French-speaking male or female patient at least 18 years old
- •Patient suffering from recent disorders (less than 6 months) of executive functions
- •Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
- •Patient affiliated or beneficiary of a social security scheme
- •Patient having signed the free and informed consent.
排除标准
- •Patient participating in another clinical study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
- •Pregnant or breastfeeding woman,
- •Patient hospitalized without consent.
- •Patient with unstable psychiatric disorders
- •Patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.)
- •Patient with executive function disorders greater than 6 months
- •Negligent hemi patient
- •Patient not familiar with the French language
- •Patient with major neuro-visual disorders.
结局指标
主要结局
The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A
时间窗: 6 weeks
Behaviour Rating Inventory of Executive Function, Adult
The effect of using the serious-game S'TIM at 6 weeks in terms of behavior with BRIEF-A
时间窗: 6 weeks
Behaviour Rating Inventory of Executive Function, Adult
The effect of using the serious-game S'TIM in terms of cognition
时间窗: 6 weeks
TAP sub-test ERFC : overall cognitive functions BREF : presence or absence of a cognitive and / or behavioral dysexecutive syndrome
次要结局
未报告次要终点
研究者
研究点 (2)
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