A Randomized Controlled Crossover Trial to Assess Efficacy of Virtual Reality Based Cognitive Training Program in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
研究概览
简要总结
This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.
详细描述
This study is a single-blind, randomized, controlled, two-period crossover trial. The intervention is done twice a week for 6 weeks. There are two arms. During the first period, participants were randomized to receive either VR-based cognitive training or usual care. After a 2-week washout period, the groups were crossed over to receive the alternative treatment for 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Raters of efficacy measures are blind to the group of a participant.
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A memory complaint by a participant or caregiver
- •Objective memory decline as defined by a delayed recall score of verbal learning test or logical memory worse than 1.0 standard deviations (SD) below age and education-adjusted normative mean
- •MMSE score better than1.5 SD below age and education-adjusted normative means
- •Global Clinical Dementia Rating (CDR) scale of 0.5 and memory score of CDR 0.5 or 1
- •Preserved activities of daily living (ADL), as defined by Korean Instrumental Activities of Daily Living < 0.4
- •Not demented
- •Hachinski Ischemic Score ≤ 4
- •Can read and write Korean
- •brain MRI or CT showing no other diseases capable of producing cognitive impairment
- •Having a reliable informant who could provide investigators with the requested information.
- •Provide written informed consent
排除标准
- •Participated in another clinical trial within the past 4 weeks
- •Other serious or unstable medical disease such as acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease, or severe renal disease
- •A clinically significant laboratory abnormality, such as an abnormal thyroid function test, abnormal low levels of vitamin B12 or folate, and positive syphilis serology
- •A primary other neurodegenerative disorder
- •Major psychiatric illness such as major depressive disorders
- •Drug or alcohol addiction during the past 10 years
- •Severe loss of vision, hearing, or communicative disability
- •Malignancy within 5 years
- •Any conditions preventing cooperation as judged by the study physician
研究组 & 干预措施
VR based cognitive training
Participants perform the VR based cognitive training under the supervision of a research nurse or psychologist for 30 min per session, twice per week, over the 6-week intervention period.
干预措施: Virtual reality based cognitive training (Other)
Usual care
Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care.
结局指标
主要结局
Change of Short form of Literacy Independent Cognitive Assessment from baseline at 6 weeks
时间窗: 6 weeks
Measurement of memory, visuospatial function, language, and executive function The range of score is from 0 to 100. The higher score means better cognition.
次要结局
- Change of Mini-Mental State Examination from baseline at 6 weeks(6 weeks)
- Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks(6 weeks)
- Change of Quality of life-Alzheimer's disease from baseline at 6 weeks(6 weeks)
- Change of Geriatric Depression Scale-15 items from baseline at 6 weeks(6 weeks)
- Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks(6 weeks)
- Change of Bayer Activities of Daily Living from baseline at 6 weeks(6 weeks)