A Single-blind Randomized Controlled Trial to Evaluate Efficacy and Safety of Immersive Virtual Reality for Post-stroke Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Mental State Examination Scale (MMSE)
研究概览
简要总结
This is a single-blind randomized controlled trial to evaluate the efficacy and safety of immersive virtual reality for post-stroke cognitive impairment.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke by neuroimaging (CT or MRI) assessment
- •18-85 years old
- •Be able to follow instructions to complete the test
- •Can tolerate the rehabilitation training of this experiment
- •First stroke
- •Patients who signed informed consent
排除标准
- •The test could not be tolerated due to organic disease
- •There is a serious mental illness resulting in inability to cooperate with or tolerate this test
- •is participating in another clinical trial involving an investigational drug or physical therapy
- •Patients who have not signed informed consent
结局指标
主要结局
Mental State Examination Scale (MMSE)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
未报告次要终点
研究者
Dingqun Bai
Director of rehabilitation Medicine
First Affiliated Hospital of Chongqing Medical University