Healthy Aging Clinical Trial
— SDSTOfficial title:
Evaluation of Senior Driving Simulation Training on Executive Function, Cognitive Promotion and EEG in Subjective Cognitive Decline and Mild Cognitive Impairment
NCT number | NCT05380284 |
Other study ID # | N202002083 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2022 |
Est. completion date | May 28, 2023 |
Verified date | May 2023 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 28, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Dementia, diagnosed by a physician and in compliance with ICD-10. - Significant mental illness or communication impairment. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mental set shifting, measured by Wisconsin Card Sorting Test | Mental set shifting is one of the sub-categories of executive function | immediate post-test | |
Primary | 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 | 3 months follow-up | |
Primary | Working memory, measured by Digit span test | Working memory is one of the sub-categories of executive function | immediate post-test | |
Primary | Change from Baseline Working memory, measured by Digit span test at 3 months | Working memory is one of the sub-categories of executive function | 3 months follow-up | |
Primary | Inhibition, measured by the Stroop Color and Word Test | Inhibition is one of the sub-categories of executive function | immediate post-test | |
Primary | 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 | 3 months follow-up | |
Secondary | Cognitive function measured by Montreal Cognitive Assessment | Cognitive function measured by Montreal Cognitive Assessment | immediate post-test | |
Secondary | Cognitive function measured by Cognitive Change Index(C-CCI) | Cognitive function measured by Cognitive Change Index(C-CCI) | immediate post-test | |
Secondary | Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months | Change from Baseline cognitive function by Montreal Cognitive Assessment at 3 months | 3 months follow-up | |
Secondary | 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 | 3 months follow-up | |
Secondary | EEG | EEG power in delta, theta, alpha, and beta band | immediate post-test | |
Secondary | Change from Baseline EEG at 3 months | EEG power in delta, theta, alpha, and beta band | 3 months follow-up | |
Secondary | Visual awareness measured by CANTAB | Visual awareness measured by CANTAB | immediate post-test | |
Secondary | Visual awareness measured by trail making test | Visual awareness measured by trail making test | immediate post-test | |
Secondary | Change from Baseline visual awareness by CANTAB at 3 months | Visual awareness measured by CANTAB | 3 months follow-up | |
Secondary | Change from Baseline visual awareness by trail making test at 3 months | Change from Baseline visual awareness by trail making test at 3 months | 3 months follow-up | |
Secondary | 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. | immediate post-test | |
Secondary | 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. | immediate post-test | |
Secondary | 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. | immediate post-test |
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