Cortico-cortical Stimulation and Robot-assisted Therapy a New Approach of Upper Limb Functional Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 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 purpose of this study is to tested the effect of combination of a paired associative stimulation of two functional interconnected areas of the cerebral cortex (posterior-parietal cortex and primary motor cortex) with robot-assisted therapy in the recovery of upper limb after stroke.
详细描述
BACKGROUND
Stroke survivors reported upper limb impairment that contribute to reducing the overall quality of life, social participation and professional activities. The impairment of the upper limb is due to motor and sensory alteration that could compromise the sensorimotor integration. The posterior parietal cortex (PPC) is a potential circuit where this integration could occur during active somatosensation. Indeed, PPC is a site of massive confluence of visual, tactile, proprioceptive, and vestibular signals. This area may be involved in transforming information about the location of targets in space, into signals related to motor intentions. This process likely occurs through parietal-motor connections, which are known to be involved in the transfer of relevant sensitive information for planning, reaching, and grasping. Paired associative stimulation (PAS) of PPC and primary motor area (M1), by means of bi-focal trans-cranial magnetic stimulation, can modulate M1 excitability. This information reinforces the hypothesis that modulation of PPC-M1 connectivity can be used as a new approach to modify motor excitability and sensorimotor interaction. Parallel, robot assisted training (RAT) can induce a plastic reorganization at the muscular afferents, spinal motor neurons, interneuron system and beyond and facilitates neural plasticity and motor relearning through goal-oriented training. The robotics device allows to train patients in an intensive, task-oriented, and top-down therapy way, increasing patients' compliance and motivation. The cognitive top-down stimulation is allowed by means of the introduction of visual feedback performed through exergaming. Recently, it has been proposed the development of new intervention strategies that combine neurostimulation of a target brain area with neurorehabilitation, such as physical therapy or virtual reality. Although both TMS and RAT have shown individually promising effects in upper limb recovery after a stroke, their combination has not been tested to date.
AIMS
- To determine whether robot-assisted therapy combined with cortico-cortical non-invasive stimulation of M1 and PPC areas can improve functional recovery of upper extremity in patients with hemiparesis due to stroke.
- To evaluate the feasibility of robot-assisted training exergaming technology for reaching and grasping training for stroke rehabilitation.
- To investigate the neurophysiological changes in PPC-M1 connectivity (through TMS EEG) to clarify the effectiveness of PAS on neuromodulation of the PPC-M1 network.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The recruiters, outcomes assessors, physical therapists, participants and their caregivers will be blinded with respect to participants' allocation for the entire period of the study.
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 chronic ischemic stroke;
- •hemiparesis due to left or right subcortical or cortical lesion in the territory of the middle cerebral artery;
- •severe or moderate residual upper limb impairment (FMA < 52 in the motor domain A/D)
排除标准
- •history of seizures;
- •severe general impairment or concomitant diseases;
- •treatment with benzodiazepines, baclofen, and antidepressants;
- •Intracranial metal implants;
- •cardiac pacemaker;
- •pregnancy status;
- •orthopedic contraindications for upper limb;
- •upper limb pain;
- •cognitive impairment (MMSE < 23);
- •presence of unilateral spatial neglect
结局指标
主要结局
Change in the Fugl-Meyer Assessment Scale for Upper Extremity (FMA-UE)
时间窗: baseline; 3weeks (end of treatment); 7weeks (follow-up)
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(baseline; 3weeks (end of treatment); 7weeks (follow-up))
- Change in the cortical connectivity(baseline; 3weeks (end of treatment); 7weeks (follow-up))
- Change in the functional movements of upper limb(baseline; 3weeks (end of treatment); 7weeks (follow-up))
- Change in the Modified Ashworth Scale(baseline; 3weeks (end of treatment); 7weeks (follow-up))
- Change in the cortical oscillations(baseline; 3weeks (end of treatment); 7weeks (follow-up))
- Change in the cortical excitability(baseline; 3weeks (end of treatment); 7weeks (follow-up))