Clinical Trials Logo

Clinical Trial Summary

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. 1. WBV ; reduces plantar flexor spasticity after stroke 2. WBV decreases poststroke spasticity, by decreasing increased stretch reflex and motor neuron activity.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03916770
Study type Interventional
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact
Status Completed
Phase N/A
Start date August 1, 2019
Completion date August 1, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT02907775 - Multi-channel Stimulation for Post Stroke Spasticity (MUSTS) N/A
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Active, not recruiting NCT03521076 - Randomized Controlled Trial of Virtual Reality N/A
Completed NCT03080454 - The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke Phase 1/Phase 2
Completed NCT02546999 - Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy? Phase 4
Active, not recruiting NCT01041157 - Botulinum Toxin Injection Efficiency Phase 1
Completed NCT00535938 - MDs on Botox Utility (MOBILITY) N/A
Terminated NCT00532532 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Associated With Multiple Sclerosis Phase 2
Terminated NCT00531466 - Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury Phase 2
Completed NCT05546190 - A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
Recruiting NCT06117020 - Single and Multiple Ascending Dose Study of MTR-601 in Healthy Individuals Phase 1
Completed NCT01603628 - BOTOX® Treatment in Pediatric Lower Limb Spasticity Phase 3
Completed NCT05510726 - Quantitative Evaluation of Muscle Stiffness in Neurological Patients With Muscle Overactivity
Not yet recruiting NCT04378946 - Error Augmentation Motor Learning Training Approach in Stroke Patients N/A
Completed NCT01603615 - BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity Phase 3
Completed NCT01251380 - Dysport® Pediatric Lower Limb Spasticity Follow-on Study Phase 3
Completed NCT00549783 - BOTOX® Economic Spasticity Trial (BEST) Phase 4
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT00076687 - Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function Phase 2