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This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.
This is a single-blind randomized controlled intervention study. Each stroke subject will undergo screening period, baseline assessment period, intervention period, endpoint assessment period.
In the screening period, the verification of inclusion/exclusion criteria and the acquisition of informed consent will be completed.
In the baseline assessment period and endpoint assessment period, cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Meanwhile, brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS).
In the intervention period, the VR group will receive immersive VR cognitive training with suitable for training intensity and the control group will receive the conventional cognitive train (occupational therapy) with suitable for training intensity in the control group. The training will lasted 20 minutes per time, 5 times per week for four weeks, with a total of 600 minutes, training frequency will be adjusted according to the patient's own conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR group (virtual reality cognitive training group) | Experimental | Immersive VR cognitive training with suitable training intensity. |
|
| OT group (occupational therapy group) | Active Comparator | Conventional cognitive training (occupational therapy) with suitable training intensity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immersive VR pathfinding training | Device | Pathfinding training with immersive VR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental State Examination Scale (MMSE) | Global cognitive function assessment. Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level. | 1. finished in 3 days before training. 2. finished 3 days after 30-days training |
| Montreal Cognitive Assessment (MoCA) | one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level. | 1. finished in 3 days before training. 2. finished 3 days after 30-days training |
| Brain functional activation (fNIRS) | Brain functional activation of each patient during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS). | 1. finished in 3 days before training. 2. finished 3 days after 30-days training |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dingqun Bai | Contact | 023-89011334 | baidingqun2014@163.com | |
| Defei Chen | Contact | +8615188017034 | 2283273437@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dingqun Bai | First Affiliated Hospital of Chongqing Medical University | Study Chair |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Occupational therapy | Other | Only receive conventional cognitive training group |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013812 |
| Therapeutics |