Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months
研究概览
简要总结
This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG.
详细描述
Driving behavior is a high cognitively demanding task, and whether the Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) can continue to drive is an important issue. This study will develop the Taiwan version of innovative, immediate feedback and environmentally safe Senior Driving Simulation Training (SDST). This study aims to establish the Senior Driving Simulation Training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), and explore the effectiveness of Senior Driving Simulation Training (SDST) on the executive function, cognitive function and EEG. The investigators intend to conduct a single-blind randomized controlled trial using a two-arm parallel-group design. Participants will be randomized by the permuted block randomization, block size of 4, into an experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) or a control group (Waiting list). The investigators plan to blind the therapists and outcome assessors to maintain the blinding methods' quality. The primary outcome indicators are mental set-shifting, working memory, and inhibition. The secondary outcome indicators are cognitive function and EEG. The investigators also evaluate visual awareness and simulator sickness. The short-term (immediate post-test) and the long-term (3, 6, and 12 months) effectiveness of the intervention on individual outcome measures will be analyzed by the generalized estimating equation. The investigators also plan to use the secondary data analysis methods to investigate the relationship between objective indicators of a driving simulator, executive function, cognitive function, EEG, visual awareness, and simulator sickness. Furthermore, the investigators will analyze the trend of EEG while the participants conducting the training, and complete the psychometric properties of the Chinese version of the Cognitive Change Index (C-CCI). This will be the first senior driving simulation training (SDST) for Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) in Taiwan. Results of the current study will provide valuable information on driving safety decisions and apply to promote the advanced driving policies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective cognitive decline( AD-8 scale ≥1 point).
- •Mild cognitive impairment (AD-8 scale ≥ 2 points), and MMSE> 24 points, can maintain personal daily activity function.
- •Can communicate in Chinese or Taiwanese.
- •At least 60 years of age.
- •Those with a car driving license.
- •No physical impairment.
- •In addition to the above conditions, participants must be voluntary and signed informed consent.
排除标准
- •Dementia, diagnosed by a physician and in compliance with ICD-
- •Significant mental illness or communication impairment.
结局指标
主要结局
Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months
时间窗: 3 months follow-up
Inhibition is one of the sub-categories of executive function
Working memory, measured by Digit span test
时间窗: immediate post-test
Working memory is one of the sub-categories of executive function
Mental set shifting, measured by Wisconsin Card Sorting Test
时间窗: immediate post-test
Mental set shifting is one of the sub-categories of executive function
Change from Baseline Working memory, measured by Digit span test at 3 months
时间窗: 3 months follow-up
Working memory is one of the sub-categories of executive function
Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months
时间窗: 3 months follow-up
Mental set shifting is one of the sub-categories of executive function
Inhibition, measured by the Stroop Color and Word Test
时间窗: immediate post-test
Inhibition is one of the sub-categories of executive function
次要结局
- Cognitive function measured by Montreal Cognitive Assessment(immediate post-test)
- Change from Baseline EEG at 3 months(3 months follow-up)
- Cognitive function measured by Cognitive Change Index(C-CCI)(immediate post-test)
- Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months(3 months follow-up)
- Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months(3 months follow-up)
- Visual awareness measured by CANTAB(immediate post-test)
- EEG(immediate post-test)
- Change from Baseline visual awareness by CANTAB at 3 months(3 months follow-up)
- simulator sickness(immediate post-test)
- Usability(immediate post-test)
- Acceptance(immediate post-test)
- Visual awareness measured by trail making test(immediate post-test)
- Change from Baseline visual awareness by trail making test at 3 months(3 months follow-up)
研究者
Huie-Ling Chiu
Assistant professor
Taipei Medical University