Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
研究概览
简要总结
The investigators hypothesize that a myoelectric (EMG) controlled virtual reality (VR) interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.
详细描述
Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression. Theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever ischemic stroke with mild to moderate motor impairment of upper limb;
- •Left or right sub-cortical or cortical lesion of the middle cerebral artery;
- •Age>18, <80 years;
- •No visuospatial, cognitive, or attention deficits;
- •Fugl-Meyer score<56.
排除标准
- •History of seizures;
- •Treatment with Benzodiazepines, Baclofen;
- •Pregnancy status;
- •Intracranial metal implant;
- •Cardiac pace-maker;
- •Orthopedic upper limb limitation;
- •Upper limb pain;
- •Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.
研究组 & 干预措施
EMG-VR real c-iTBS
Subjects will perform 12 sessions (~30 minutes, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after real cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.
干预措施: Virtual Reality Interface + Cerebellar iTBS (c-iTBS) (Device)
EMG-VR sham c-iTBS
Subjects will perform 12 sessions (~30 minute, 3 times per weeks for 4 weeks) of assisted EMG control task (aEC) after sham cerebellar intermittent theta burst stimulation (c-iTBS) for paretic upper limb.
干预措施: Virtual Reality + Sham Cerebellar iTBS (sham c-iTBS) (Device)
Conventional Physical Therapy
Subjects will perform 12 sessions (~30 minutes, 3 times per weeks for 4 weeks) of physical therapy targeting on motor functionality of upper limb.
干预措施: Physical Therapy (Other)
结局指标
主要结局
Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
时间窗: baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.
Comprehensive clinical measurement tool of upper limb functions after stroke. Range score form 0 to 66 points, a higher score represents an improvement.
次要结局
- Change in the Box and Block test (BBT)(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)
- Change in modified Barthel Index (mBI) score(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)
- Change in the Nine Hole Peg Test (NHPT)(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)
- Change in muscle activation patterns (EMG)(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)
- Change in force-control(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)
- Change in Motor Evoked Potentials' (MEP) Amplitude(baseline: T0, post-treatment (3 weeks): T1, follow-up (6 weeks from T1): T2.)