Usability of Virtual Reality in Subjects With Mild Cognitive Impairment or Alzheimer's Disease. MeMO-RV2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Evaluate the acceptability of the RV
研究概览
简要总结
Cognitive and memory problems characterize Alzheimer's disease (AD). Along with these disorders, psychological and behavioral symptoms (also known as neuropsychiatric symptoms) , as well as pathophysiological processes are frequently found and involved significantly in maintaining autonomy, prognosis and treatment of the disease. Apathy or disorder motivation is the most common disorder behavior and early stages of cognitive impairment. Apathy is particularly associated with cognitive difficulties such as attention deficit disorder - concentration.
In terms of prevention as term care , there is now a broad consensus that interventions on cognition and behavior must not be limited to pharmacological treatment but should also promote non-drug approaches.
Interest in video games (serious games and serious games) as intervention support rehabilitation is growing. Similarly, the virtual reality (VR) and the new information technologies and communications offer significant opportunities in terms of rehabilitation and therapeutic assistance.
This protocol is part of a European project to propose techniques for improving the treatment of people at risk of social exclusion ( VERVE project ) aims .
A first experiment conducted in 2013 showed the acceptability of Virtual Reality (VR) in healthy elderly subjects. In a second step , it is important to validate the feasibility of using the RV or in frail subjects with mild cognitive impairment or Alzheimer's disease in mild to moderate in a clinical environment.
This is a biomedical , randomized given to a group of patients with mild cognitive impairment or Alzheimer's disease & diseases associated with mild to moderate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥ 60 years.
- •Introducing either:
- •MCI diagnosis (ICD-10)
- •diagnosis of Alzheimer's disease or mixed mild to moderate (ICD 10).
- •Subject undisturbed locomotion requiring the use of a walking aid.
- •Score at the Mini Mental Test (MMSE) between 16 and 28.
排除标准
- •Presence of psychiatric disorders
- •Presence of eye diseases causing blurred vision can not be corrected with lenses or glasses.
- •Presence of auditory pathologies causing a significant decrease in hearing unaided.
- •High sensitivity to motion sickness.
- •migraine disease.
- •Subject epileptic.
- •Subject vulnerable
结局指标
主要结局
Evaluate the acceptability of the RV
时间窗: At the end of experience (45 min)
Analog scale assessment of satisfaction from 0 to 100% is given at the end of experience about that evaluates: * The general acceptability of the RV * His sense of security * The environment of RV * The degree of motivation
次要结局
- Evaluate the motivation of subjects (interest, cognition) is greater in the virtual environment during the VR experience compared to a conventional cognitive stimulation activity (CSC).(At the end of experience (45 min))