The Use of Immersive Virtual Reality for Upper Limb Neurorehabilitation in Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mindmaze SA
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
研究概览
简要总结
The present study aims at investigating (i) the feasibility in chronic stroke of using a dedicated virtual reality (VR) based system that embeds real-time 3D motion capture and embodied visual feedback to deliver functional exercises designed for training of impaired upper limb motor skills, (ii) whether chronic stroke survivors improve in functional outcomes in the upper limb when exposed to intensive VR-based therapy, and (iii) safety and tolerance to such a technology. The investigators hypothesize that intensive VR-based rehabilitation may lead to high rehabilitation doses and functional improvement in chronic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic minor-to-moderate (0<NIHSS<16) stroke with hemiparesis and experiencing arm motor difficulties
- •At least 6 months after stroke incident
- •Maximum 4 on the Medical Research Council Scale (MRCS) for shoulder elevation and elbow flexion/extension
- •18 years and older
- •First ever stroke
排除标准
- •Participating in another movement treatment study at the time of the present study
- •Severe cognitive impairment (Mini Mental Status Examination score < 18 points)
- •Orthopedic impairment or visual disorders limiting the treatment
- •Unable to give informed consent form
- •Risk of epileptic seizures
结局指标
主要结局
Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
时间窗: 5 weeks
Rehabilitation dose: goal-directed movements (i.e. number of intended movements to achieve a task)
Training intensity: number of goal-directed movements per minute of effective training time.
时间窗: 5 weeks
Training intensity: number of goal-directed movements per minute of effective training time.
Change in Upper limb function assessed with Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
时间窗: At baseline, 5 weeks (post intervention) and 9 weeks (follow-up)
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
次要结局
- Change in Modified Medical Research Council Scale (mMRCS)(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
- Change in Functional Independence Measure (FIM)(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
- Change in Visual Analog Scale (VAS) for Pain(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
- Change in kinematic metrics/goniometry (active range of motion).(At baseline, 5 weeks (post intervention) and 9 weeks (follow-up))
- Safety and Acceptance of Technology assessed with a questionnaire(5 weeks)