The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research

Conditions
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Physiology, Muscle Spasticity

Intervention / Treatment
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* Device: Sham vibrator
* Device: Real vibrator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Epilepsy Patients who received botulinum A toxin in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Whole Body Vibration (WBV) will be applied to Poststroke Hemiplegia. The patients are divided in two groups; WBV group and shame WBV group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: whole body vibration<br>WBV(whole body vibration) will be applied to interventional group for 4 weeks, 3 days a week, a total of 12 sessions while standing upright with the WBV powerplate pro5 device.(Vibration frequency: 30Hz, amplitude: 2.2 mm at progressively increasing duration) | Device: Real vibrator<br>* The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position<br>* Other names: Real WBV;|
| Sham Comparator: Sham whole body vibration<br>The sham WBV will be applied to the Control group. A WBV device with 99.5% weakened amplitude will be used for sham WBV. (Application duration of the sham WBV will be same as WBV in the treatment group ). | Device: Sham vibrator<br>* The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.<br>* Other names: Sham WBV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spasticity-torque | Spasticity will be measured as a torque. The unit is Nm | 4 weeks | 
| spasiticity-modified Ashworth scale | The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS) | 4 weeks | 
| spasticity-homosynaptic post-activation depression (HPAD) | 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 | 4 weeks | 
| Motor neuron activity-Hmax / Mmax ratio | Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle, vibration, H reflex, H/M ratio, spasticity