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This study evaluates efficacy and safety of virtual reality (VR)-based cognitive training program in amnestic mild cognitive impairment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR based cognitive training | Experimental | 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. |
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| Usual care | No Intervention | Participants take some medication for risk factors and cognitive impairment and receive health advice as a usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality based cognitive training | Other | The VR-based cognitive training consists of a three-dimensional simulation of home, a mart, bus stop, and street. It provides an integrative cognitive training experience where participants are required to accomplish some common ADL's in three frequently visited places: home, a supermarket, and bus stop. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Short form of Literacy Independent Cognitive Assessment from baseline at 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Mini-Mental State Examination from baseline at 6 weeks | Evaluation of global cognition The range of score is from 0 to 30. The higher score means better cognition. | 6 weeks |
| Change of Clinical Dementia Rating Scale-Sum of Boxes from baseline at 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong Hye Choi, MD, PhD | Contact | 82 32 890 3659 | seonghye@inha.ac.kr | |
| Hye Lan Na, RN | Contact | 82 32 890 1119 | nhyelan@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Seong Hye Choi, MD, PhD | Inha University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Recruiting | Incheon | 22332 | South Korea |
We will decide it later.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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This study is a single-blind, randomized, controlled, two-period crossover trial.
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Raters of efficacy measures are blind to the group of a participant.
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Evaluation of global cognition The range of score is from 0 to 18. The higher score means better cognition. |
| 6 weeks |
| Change of Quality of life-Alzheimer's disease from baseline at 6 weeks | Evaluation of quality of life The range of score is from 0 to 52. The higher score means better quality of life. | 6 weeks |
| Change of Geriatric Depression Scale-15 items from baseline at 6 weeks | Evaluation of mood The range of score is from 0 to 15. A higher score means more depression. | 6 weeks |
| Change of Prospective and Retrospective Memory Questionnaire from baseline at 6 weeks | Evaluation of subjective memory The range of score is from 16 to 80. The higher score means more memory impairment. | 6 weeks |
| Change of Bayer Activities of Daily Living from baseline at 6 weeks | Evaluation of activities of daily living The range of score is from 1 to 10. The higher score means worse ADL. | 6 weeks |
| Ewha Womans University Mokdong Hospital | Not yet recruiting | Seoul | South Korea |
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