The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- spasticity-torque
研究概览
简要总结
The primary purpose of this study is to show whether WBV application has antispastic effect. The secondary aim is to demonstrate whether WBV has neuromodulatory activity on increased stretch reflex and motor neuron activity, which is the basis of the pathophysiology of spasticity.Hypotheses of this study:Whole body vibration in poststroke hemiplegia reduces ankle plantar flexion spasticity.
- WBV ; reduces plantar flexor spasticity after stroke
- WBV decreases poststroke spasticity, by decreasing increased stretch reflex and motor neuron activity.
详细描述
Patients with a stroke of at least 1 month before and with a history of ankle plantar flexion spasticity will be included in the study. Conventional rehabilitation program will be applied to all patients (n=48).The intervention group (n=24) will be applied for 4 weeks, 3days a week, a total of 12 sessions with the WBV powerplate pro5 device. In the WBV group, the frequency and acceleration of vibration will be 30Hz and 18.0m/s2, respectively. The WBV exercise intensity will progressively increase throughout the twelve-session. In the control group, the same procedures will be followed. However, unlike the WBV group, a vibration will be given whose acceleration is attenuated by 99.5%.The surface Electromyography (EMG) and degree of spasticity of soleus muscle will be evaluated at the beginning and end of the all sessions. Soleus H-reflex will be recorded with surface EMG.To obtain the H-reflex response, the posterior tibial nerve in the popliteal region will be stimulated by using a stimulator (FE155 Stimulator HC ADInstrument, Oxford UK) with 1 ms-pulse current. The records will be taken with the Ag / AgCl electrodes (Kendall ®Coviden, self-adhesive electrodes) placed on skin according to the SENIAM protocol. The degree of spasticity will be measured as a soleus muscle tone torque on a fixed angular velocity moving platform.The data will be recorded with the PowerLab data acquisition device
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 (Participant)
盲法说明
Patients will be blind to treatment
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic / hemorrhagic poststroke hemiplegia aged 18-90 years,
- •Stroke time ≥1 months,
- •Ankle plantar flexor spasticity MAS ≥1,
- •Brunnstrom stage ≥3 for lower extremity,
- •Patients who were standing for more than five minutes and had a static balance
排除标准
- •Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
- •Lower extremity fracture,
- •Findings or suspicion of active deep vein thrombosis,
- •A history of deep vein thrombosis and pulmonary embolism,
- •Orthostatic hypotension
- •Resistant hypertension,
- •Peripheral nerve lesions such as polyneuropathy, radiculopathy
- •Active inflammatory, rheumatologic or infectious disease,
- •Ankle,knee or hip joint contracture,
- •Presence of panic attacks,
- •Patients with dizziness and balance problems,
- •Patients with not intact skin surface to connect electrodes
- •Patients with communication problems: aphasia, major depression
- •Patients who received botulinum A toxin in the last 6 months
结局指标
主要结局
spasticity-torque
时间窗: 4 weeks
Spasticity will be measured as a torque. The unit is Nm
spasiticity-modified Ashworth scale
时间窗: 4 weeks
The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)
Motor neuron activity-Hmax / Mmax ratio
时间窗: 4 weeks
Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool
spasticity-homosynaptic post-activation depression (HPAD)
时间窗: 4 weeks
Homosynaptic post-activation depression is a presynaptic mechanism regulating the excitability of the stretch reflex. Decreased presynaptic inhibition and homosynaptic depression are also thought to play a role in the pathophysiology of spasticity. The higher HPAD, the lower spasticity
次要结局
未报告次要终点