An interventional study of Senior Driving Simulation Training and Waiting list control in MCI, Subjective Cognitive Decline and Healthy Aging, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Prevention
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 90 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
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Exclusion Criteria:
Senior Driving Simulation Training
Other: Senior Driving Simulation Training
Ｗaiting-list
Other: Waiting list control
The experimental group (Senior Driving Simulation Training: 30-mins training session two times per week for 5 weeks, with a total of 10 sessions) .
The control group is waiting list control. They will also receive the (Senior Driving Simulation Training) after all research is done.
Mental set shifting, measured by Wisconsin Card Sorting Test
Mental set shifting is one of the sub-categories of executive function
Time frame: immediate post-test
Change from Baseline Mental set shifting, measured by Wisconsin Card Sorting Test at 3 months
Mental set shifting is one of the sub-categories of executive function
Time frame: 3 months follow-up
Working memory, measured by Digit span test
Working memory is one of the sub-categories of executive function
Time frame: immediate post-test
Change from Baseline Working memory, measured by Digit span test at 3 months
Working memory is one of the sub-categories of executive function
Time frame: 3 months follow-up
Inhibition, measured by the Stroop Color and Word Test
Inhibition is one of the sub-categories of executive function
Time frame: immediate post-test
Change from Baseline Inhibition, measured by the Stroop Color and Word Test at 3 months
Inhibition is one of the sub-categories of executive function
Time frame: 3 months follow-up
Cognitive function measured by Montreal Cognitive Assessment
Cognitive function measured by Montreal Cognitive Assessment
Time frame: immediate post-test
Cognitive function measured by Cognitive Change Index(C-CCI)
Cognitive function measured by Cognitive Change Index(C-CCI)
Time frame: immediate post-test
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months
Time frame: 3 months follow-up
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Change from Baseline cognitive function by Cognitive Change Index(C-CCI)at 3 months
Time frame: 3 months follow-up
EEG
EEG power in delta, theta, alpha, and beta band
Time frame: immediate post-test
Change from Baseline EEG at 3 months
EEG power in delta, theta, alpha, and beta band
Time frame: 3 months follow-up
Visual awareness measured by CANTAB
Visual awareness measured by CANTAB
Time frame: immediate post-test
Visual awareness measured by trail making test
Visual awareness measured by trail making test
Time frame: immediate post-test
Change from Baseline visual awareness by CANTAB at 3 months
Visual awareness measured by CANTAB
Time frame: 3 months follow-up
Change from Baseline visual awareness by trail making test at 3 months
Change from Baseline visual awareness by trail making test at 3 months
Time frame: 3 months follow-up
simulator sickness
Simulator Sickness Questionnaire (SSQ). The 16-item SSQ will be used to assess participants' sickness levels. This is the 4-point Likert scale (0 - "None" to 3 - "Severe"), and the higher total score reflects more severe sickness.
Time frame: immediate post-test
Usability
The System Usability Scale (SUS) will be used to access the usability, this scale consists of 10 items, and the higher total score reflects better usability.
Time frame: immediate post-test
Acceptance
The Technology Acceptance for Older Adults Scale will be used to access the acceptance, this scale consists of 17 items, and the higher total score reflects better acceptance.
Time frame: immediate post-test
Plan to share: No
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Taipei Medical University