Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Postural stability test (Grail Motekforce)
研究概览
简要总结
In our study, we tested the hypothesis of the safe effect applicability of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 points on a scale Rankin.
详细描述
The neurological consequences of stroke cover the motor, sensory, visual, affective, cognitive and speech spheres. 55-75% of stroke survivors suffer from motor impairments, caused, inter alia, by hemiparesis, which substantially reduce the quality of their life. In addition, neurocognitive functions, especially memory, visual-constructive abilities and executive functions, are often affected by stroke. Cognitive impairments appear in 83% patients in at least one cognitive domain, whereas in 50% patients appear in multiple (≥3) domains. These disorders affect the quality of life of patients, their skills of daily activity (the ability to go to the store, prepare food, plan their actions for organizing a daily routine), social adaptation. One of the rehabilitation methods that are comprehensively suitable for the recovering on of stroke consequences is the intervention using virtual reality. The VR method is used for the rehabilitation of stroke patients with various motor and neurocognitive deficits: one-sided spatial ignorance, disorders of attention, memory, mood, visual-spatial functions, and constructive abilities.
In our study, we tested the hypothesis of the applicability of the safe effect of motor training in the immersion high-tech polymodal VR system not only on the parameters of balance, gait, and motor status of the patient, but also on his cognitive functions and mental health in patients with a degree of disability no more than 3 score on a modified Rankin Scale.
Stroke patients participated in the study in Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health in Moscow, Russia. The study was run between October 2019 and July 2020 and was approved by a local ethic committee and followed principles of the Declaration of Helsinki. The patients stayed in a 24-hour hospital and underwent a rehabilitation course. This course included a VR Trainig of 10 sessions of 40 minutes each, which the patients took over two weeks. VR training was conducted on the GRAIL system equipment (Motekforce, Netherlands), consisting of a semi-cylindrical screen, treadmill, 10 infrared cameras (Vicon, UK) and reflective markers, and software providing biofeedback in real time. For complex recovery in VR, exercises stimulate the motor, cognitive and behavioral spheres, including visual-spatial orientation, the process of attention (with one and duai-task), executive functions, lowering the level of anxiety, hand-eye coordination and balance.Training applications were based on the therapeutic goals for every patient, according to postural stability and gait adaptation.
Before and after the end of the training, the patient's condition was assessed, including measurements in motor and daily living activity, measurements in mental health, measurements in Virtual Reality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a stroke, transferred at least 2 weeks ago; with no history of neurological or psychiatric disorders; able to maintain an upright posture and walk without support or with minimal support for at least 30 minutes; with stable hemodynamics;
排除标准
- •not having epileptic activity; not having serious ophthalmic disorders; less than 24 scores in MoCA
结局指标
主要结局
Postural stability test (Grail Motekforce)
时间窗: Change from baseline at 2 weeks
The subject's ability to remain balanced under four different conditions is evaluated (cm/s).
Six-minute walk test (6MWT) (Grail Motekforce)
时间窗: Change from baseline at 2 weeks
The 6-minute walk test evaluates how much distance a subject can cover in six minutes (m).
State-Trait Anxiety Inventory
时间窗: Change from baseline at 2 weeks
Examines two types of anxiety - state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic) with the score range from 20 to 80, where higher scores correspond to greater anxiety
Beck Depression Inventory
时间窗: Change from baseline at 2 weeks
Measures the severity of depression (0-63; 30-63 scores indicate severe depression)
次要结局
- Timed Up and Go Test(Change from baseline at 2 weeks)
- Hauser Ambulation Index(Change from baseline at 2 weeks)
- Functional Independence Measure(Change from baseline at 2 weeks)
- Berg Balance Scale(Change from baseline at 2 weeks)
- Standing Balance Test(Change from baseline at 2 weeks)
- Rivermead Activities of Daily Living Scales(Change from baseline at 2 weeks)