Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
研究概览
简要总结
A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.
详细描述
A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.
The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the subacute groups:
- •Two weeks after the onset of stroke, however less than 0.5 year
- •Mini-Mental State Examination (MMSE)>21
- •Able to sit up for at least 1 hour
- •Fugl-Meyer Assessment (FMA) upper limb <30
- •Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
- •Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
- •For the chronic device assisted group:
- •At least 0.5 year after the onset of stroke
- •Mini-Mental State Examination (MMSE)>21
- •Able to sit up for at least 1 hour
- •Fugl-Meyer Assessment (FMA) upper limb <30
- •Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
- •Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)
排除标准
- •Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:
- •Currently pregnant
- •Dysphasia (language deficiency)
- •Post-stroke neglect
- •Pacemaker implantation,
- •Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
- •The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).
研究组 & 干预措施
subacute device assisted group
干预措施: Robot assisted upper limb rehabilitation (Device)
subacute conventional group
干预措施: Robot assisted upper limb rehabilitation (Device)
chronic device assisted group
干预措施: Robot assisted upper limb rehabilitation (Device)
结局指标
主要结局
Fugl-Meyer Assessment (FMA) of the Upper Limb before the training
时间窗: For each subject, the FMA score will be measured one day before the training.
Fugl-Meyer Assessment (FMA) of the Upper Limb after the training
时间窗: For each subject, the FMA score will be measured one day after the 20-session training program.
Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up
时间窗: For each subject, the FMA score will be measured 3 months later after the last day of the training.
次要结局
- Modified Ashworth Scale (MAS)(For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.)
- Action Research Arm Test (ARAT)(For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training.)
研究者
Xiaoling Hu
Principal Investigator
The Hong Kong Polytechnic University