Cognitive Decline, Stroke
Conditions
Keywords
stroke, virtual reality, fNIRS, cognitive impairment
Brief summary
This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.
Detailed description
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.
Interventions
DEVICEimmersive VR pathfinding training
Pathfinding training with immersive VR.
OTHEROccupational therapy
Only receive conventional cognitive training group
Sponsors
Dingqun Bai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of stroke by neuroimaging (CT or MRI) assessment 2. 18-85 years old 3. Be able to follow instructions to complete the test 4. Can tolerate the rehabilitation training of this experiment 5. First stroke 6. Patients who signed informed consent
Exclusion criteria
1. The test could not be tolerated due to organic disease 2. There is a serious mental illness resulting in inability to cooperate with or tolerate this test 3. is participating in another clinical trial involving an investigational drug or physical therapy 4. Patients who have not signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental State Examination Scale (MMSE) | 1. finished in 3 days before training. 2. finished 3 days after 30-days training | 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. |
| Montreal Cognitive Assessment (MoCA) | 1. finished in 3 days before training. 2. finished 3 days after 30-days training | 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. |
| Brain functional activation (fNIRS) | 1. finished in 3 days before training. 2. finished 3 days after 30-days training | 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). |
Contacts
Primary ContactDingqun Bai
Backup ContactDefei Chen
Outcome results
None listed