Effects of Virtual Reality Features on Upper Limb Motor Function in Post-stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
研究概览
简要总结
Stroke rank second among the top causes of death, affecting millions of people in the worldwide. Approximately 70-80% survivors of stroke could experience various levels of upper limb motor impairments, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. As bottleneck effect in traditional rehabilitation techniques become apparent, a number of emerging technologies are being used in rehabilitation treatment in an attempt to break down this barrier.Studies have shown that virtual reality (VR) training can effectively promote the remodeling of the central nervous system and has become an important research direction for motor function rehabilitation.However, most current studies still focus on evaluating the overall intervention effect of VR, with little examination of its intrinsic properties and a lack of exploration of the sense of ownership (SOO) and agency (SOA).
Hence, this study conducted different VR interventions on stroke patients to evaluate the effects of the intrinsic properties of VR and the body illusion it produces on the rehabilitation of their upper limb motor function.
This study is a single-blind randomized controlled trial. A total of 120 participants will be enrolled and divided into a control group, an interactive VR group, and an immersive and interactive VR group. All groups will be tested on the virtual hand illusion before the intervention. The intervention will last for a fortnight, four times a week for one hour each time. Assessment will be conducted before the intervention, at the end of the intervention, and at week 6 for follow-up. The primary outcome measure is the "Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)". The secondary outcome measures are "SOO questionnaire", "proprioceptive drift scale", "action research arm test (ARAT)", "NIH stroke scale (NIHSS)", "mini mental state examination (MMSE)", "electromyography (EMG)", "electroencephalography (EEG)" and "functional Magnetic Resonance Imaging (fMRI)".
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First episode of stroke, hemorrhagic or ischemic, confirmed by computed tomography or magnetic resonance imaging of the brain;
- •Age 40-80 years, either male or female;
- •3-12 months since stroke occurrence;
- •Mild-to-moderate or moderate-to-severe upper extremity impairment, with a FMA-UE score between 16 and 53;
- •Basic ability to communicate and comprehend the research instructions, with a score of 21 and above on the MMSE scale;
- •Agreement to participate in the study, with an informed consent form duly signed by the patient or a family member.
排除标准
- •The presence of ferromagnetic metals implanted in the body;
- •Visual or hearing deficits;
- •Unstable medical conditions;
- •History of receiving similar VR training in the past;
- •A history of myasthenia gravis, multiple sclerosis, muscular dystrophy, or other diseases that may cause upper limb movement disorders.
研究组 & 干预措施
Immersive and Interactive VR group
The design of this group combines rich immersive VR scenes and specific interactive tasks. Specifically, there were two VR scenes: (1) Natural scenery: The subjects were on a quiet forest path, surrounded by tall trees, birdsong, and the sound of gurgling water. In this scene, the program sets the virtual hand on the hemiplegic side to perform the task of grasping the sphericalfruit on the tree. Each time the fruit is grasped for 3 seconds, and then released for 3 seconds; (2) City park: The subject was located in a city park surrounded by the sounds of children playing and the background sounds of the natural environment. In this scenario, the program sets the virtual hand on the hemiplegic side to carry out the task of grasping a ping-pong ball in the park, holding it for 3 seconds at a time and then releasing it for 3 seconds. To improve the actual participation, a real object the same as the virtual object will be provided in the real world, and subjects will be instructed to use
干预措施: virtual reality (VR) head mounted display (Device)
Interactive VR group
The VR scene in this group focuses on basic motor interaction, and the virtual background is the same as the control group. The program will set the virtual hand on the hemiplegic side to complete specific interaction tasks, such as grasping the virtual ball, holding the virtual ball for 3 seconds each time, and then releasing it for 3 seconds. At the same time, a real sphere of the same size and color as the virtual ball will be provided in the real world, and the subject will be instructed to perform the same movement simultaneously as much as possible with the real hand on the hemiplegic side.
干预措施: virtual reality (VR) head mounted display (Device)
Control group
subjects were asked to wear an HTC Vive HMD and enter a simple virtual testing environment. The environment has no complex narrative or visual effects, nor does it emphasize specific interaction tasks. It only includes a realistic virtual hand model of the hemiplegic side and the same virtual background as the real experiment, both are presented from a first-person perspective. The program will set the virtual hand on the hemiplegic side to perform simple and repetitive grasping movements. Each fist hold lasts for 3 seconds and then releases for 3 seconds. At the same time, the subject will be instructed to perform the same movement simultaneously with the real hand on the hemiplegic side as much as possible.
干预措施: virtual reality (VR) head mounted display (Device)
结局指标
主要结局
Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)
时间窗: There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) covers all aspects of upper limb function, such as movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand, with a total of 33 assessment items. Patients were assessed according to a specific scale with a total score of 66, with higher scores indicating better recovery of upper limb function.
次要结局
- Action Research Arm Test(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- Surface electromyography(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- Sense of ownership questionnaire(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- Proprioceptive drift scale(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- Mini-mental state examination(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- Electroencephalography(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- National institutes of health stroke scale(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)
- functional Magnetic Resonance Imaging(There were 3 time points for evaluation: before intervention, on the day of intervention end, 4 weeks after intervention end)