Randomized Parallel-group Study Evaluating the Effectiveness and Cost-effectiveness of the Co-administration of MindMotionPRO Plus Standard Practice Versus Standard Practice in Early Post-stroke Upper-limb Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mindmaze SA
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
研究概览
简要总结
Randomised controlled multi-centered study using MindMotionPRO, an immersive virtual reality based system for upper limb motor rehabilitation in early post-stroke patients. The study aims to evaluate the ability of MindMotionPRO technology to increase the rehabilitation dose. Effectiveness will be evaluated by validated rehabilitation performance scales. Cost-effectiveness will be assessed by the resource utilization.
详细描述
The goal of the study is to show that MindMotionPRO is a tool that allows a patient to increase the amount of rehabilitation therapy performed. This study will measure the rehabilitation dose, as measured by the duration of the rehabilitation session and the number of exercises performed by the patient. The study hypothesis is that patients in the MindMotionPRO group will spend more time performing rehabilitation exercises than in the Self-Directed Prescribed exercises group. The effectiveness of the MindMotionPRO versus Self-Directed Prescribed Exercises will also be measured, based on the change in rehabilitation performance measures. The cost-effectiveness will be measured by the resource utilization, as defined by the time spent by the therapist providing the rehabilitation session.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female > 18 years old
- •First ever unilateral supratentorial ischemic stroke with contralateral upper extremity weakness
- •1 to 6 weeks post-stroke
- •Able to give informed consent
- •Not participating any other intervention studies
- •Experiencing motor difficulties in using the paretic arm, with a FMA-UE score in the range of 20 to 40 out of 66
- •Stroke severity with NIHSS score between 5 (mild) and 14 (moderate) out of 42
- •The participant is expected to remain available (geographically stable) for 4 months after enrolment.
排除标准
- •Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate to therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
- •Recurrent and moderate to high upper limb pain limiting delivery of rehabilitation dose
- •History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
- •Mild to severe cognitive impairment (Mini mental state exam (MMSE) score < 24/30)
- •Depression (Hospital Anxiety and Depression Scale > 8/21)
- •Moderate to severe hemispatial neglect compromising the ability to take part to the study, as determined by the Bells tests (> 6 errors)
- •Brain stem stroke
研究组 & 干预措施
MindMotionPRO
MindMotionPRO exercises in addition to standard practice for upper limb rehabilitation
干预措施: MindMotionPRO (Device)
Self-Directed Prescribed Exercises
Self-Directed Prescribed Exercises in addition to standard practice for upper limb rehabilitation
干预措施: Self-Directed Prescribed Exercises (Other)
结局指标
主要结局
Rehabilitation dose as measured by the duration of the rehabilitation session without planned rest periods
时间窗: 4 weeks
次要结局
- Change from Baseline in upper extremity motor ability measured by the streamlined Wolf Motor Function Test (sWMFT) score(baseline, 4 weeks, 16 weeks)
- Change from Baseline in the severity of stroke symptoms as measured by the NIH stroke scale (NIHSS)(baseline, 4 weeks, 16 weeks)
- Motivation measured by the Intrinsic Motivation Index (IMI)(1 week and 4 weeks)
- Number of exercises performed(4 weeks)
- Change from Baseline in self-care ability measured by the Barthel index (BI)(baseline, 4 weeks, 16 weeks)
- Change from Baseline in arm function in daily activities as measured by the Motor Activity Log (MAL)(baseline, 4 weeks, 16 weeks)
- Change from Baseline in functional independence measured by the Modified Ranking Scale (MRS) and associated disability-adjusted life year (DALY)(baseline, 4 weeks, 16 weeks)
- Change from Baseline in the general health status as measured by the Stroke Impact scale (SIS)(baseline, 4 weeks, 16 weeks)
- Change from Baseline in upper extremity motor function measured by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and its subscales(baseline, 4 weeks, 16 weeks)