Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Baseline EMG
研究概览
简要总结
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.
详细描述
Randomized control trial : 28 patients with active vibrations vs. 28 patients with sham stimulation Subacute phase : D15 to 6 months after stroke or patients with traumatic brain injury with similar semiology as stroke (hemiparesis) Measure at baseline : Electrophysiological investigations (EMG,EEG, MRI, clinical evaluation) Treatment of 5 weeks with 3 sessions of vibrations or sham a week Evaluation at mid time (electrophysiology and clinical examinations) Final examination (electrophysiology, MRI and clinical examination)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury)
- •French spoken
- •Affiliated to a French social insurance
- •No previous traumatic, vascular or neurodegenerative injuries
- •Having presented during the acute phase or presenting a motor deficit of one of the lower limbs
- •Presenting an absence of autonomy of walking at the entrance of the rehabilitation department
- •In the sub-acute phase, i.e. from 15 days to 6 months after the accident
- •Presenting moderate cognitive disorders allowing them to understand instructions and give their consent
排除标准
- •strong cognitive disorders
- •maintenance of justice, tutelage, legal guardianship
- •Pregnancy and breastfeeding
- •Outpatients who do not have weekly follow-up in the rehabilitation department
结局指标
主要结局
Baseline EMG
时间窗: Evaluation at baseline (4 days before treatment)
H-reflex and reciprocal inhibition
EMG change from baseline after 2-week treatment
时间窗: Evaluation during the 3rd week of treatment
H-reflex and reciprocal inhibition
EEG change from baseline after 2-week treatment
时间窗: Evaluation during the 3rd week of treatment
SEP and resting state activity
Baseline EEG
时间窗: Evaluation at baseline (4 days before treatment)
SEP and resting state activity
EMG change after the 5-week treatment
时间窗: Evaluation 4 days after the end of the 5-week treatment
H-reflex and reciprocal inhibition
EEG change after the 5-week treatment
时间窗: Evaluation 4 days after the end of the 5-week treatment
SEP and resting state activity
次要结局
- Baseline Muscle Strength(Evaluation at baseline (4 days before treatment))
- Walking from baseline after 5-week treatment(Evaluation 4 days after the end of the 5-week treatment)
- Change in MD(Evaluation 4 days after the end of the 5-week treatment)
- Sensorimotor function change from baseline after 5-week treatment(Evaluation 4 days after the end of the 5-week treatment)
- Spasticity change from baseline after 2-week treatment(Evaluation during the 3rd week of treatment)
- Baseline Balance(Evaluation at baseline (4 days before treatment))
- Baseline walking(Evaluation at baseline (4 days before treatment))
- Change in FA(Evaluation 4 days after the end of the 5-week treatment)
- Baseline MD(Evaluation at baseline (4 days before treatment))
- Baseline FA(Evaluation at baseline (4 days before treatment))
- Muscle Strength change from baseline after 2-week treatment(Evaluation during the 3rd week of treatment)
- Muscle Strength change from baseline after 5-week treatment(Evaluation 4 days after the end of the 5-week treatment)
- Baseline Spasticity(Evaluation at baseline (4 days before treatment))
- Spasticity change from baseline after 5-week treatment(Evaluation 4 days after the end of the 5-week treatment)
- Baseline sensorimotor function(Evaluation at baseline (4 days before treatment))
- Sensorimotor function change from baseline after 2-week treatment(Evaluation during the 3rd week of treatment)
- Balance change from baseline after 2-week treatment(Evaluation during the 3rd week of treatment)
- Balance change from baseline after 5-week treatment(Evaluation 4 days after the end of the 5-week treatment)
- Walking from baseline after 2-week treatment(Evaluation during the 3rd week of treatment)