The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia (WBV)
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|ClinicalTrials.gov Identifier: NCT03916770|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : August 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Muscle Spasticity Physiology||Device: Sham vibrator Device: Real vibrator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 Description:||Patients will be blind to treatment|
|Official Title:||The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research|
|Actual Study Start Date :||August 1, 2019|
|Actual Primary Completion Date :||March 1, 2020|
|Actual Study Completion Date :||August 1, 2020|
Active Comparator: whole body vibration
WBV(whole body vibration) will be applied to interventional group for 4 weeks, 2 days a week, a total of 8 sessions while standing upright with the WBV powerplate pro5 device.(Vibration frequency: 30Hz, amplitude: 2.2 mm and duration 1x10 seconds (starting period) + 3x30 seconds).
Device: Real vibrator
The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
Other Name: Real WBV
Sham Comparator: Sham whole body vibration
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 1x10 seconds (starting period) + 3x30 seconds).
Device: Sham vibrator
The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.
Other Name: Sham WBV
- Spasticity [ Time Frame: 4 weeks ]Spasticity will be measured as a torque. The unit is Nm
- Motor neuron activity [ Time Frame: 4 weeks ]
Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool.
• Soleus muscle stretch reflex activity (Soleus T-reflex and H reflex responses)
- Muscle stretch reflex activity [ Time Frame: 4 weeks ]A stretch reflex activity is determined by measuring the T reflex and H reflex amplitude. The amplitude unit will be mA.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916770
|Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey|
|Study Chair:||Ayşenur Bardak, Prof||Istanbul Physical Medicine Rehabilitation Training and Research Hospital|