Clinical Trials Directory

Trials / Completed

CompletedNCT03916770

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Other Government
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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.

Detailed 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

Conditions

Interventions

TypeNameDescription
DEVICESham vibratorThe Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.
DEVICEReal vibratorThe intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position

Timeline

Start date
2019-08-01
Primary completion
2020-03-01
Completion
2020-08-01
First posted
2019-04-16
Last updated
2022-01-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03916770. Inclusion in this directory is not an endorsement.