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

December 27, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ischemic / hemorrhagic poststroke hemiplegia aged 18-90 years,
  2. Stroke time ≥1 months,
  3. Ankle plantar flexor spasticity MAS ≥1,
  4. Brunnstrom stage ≥3 for lower extremity,
  5. Patients who were standing for more than five minutes and had a static balance

Exclusion Criteria:

  1. Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
  2. Lower extremity fracture,
  3. Findings or suspicion of active deep vein thrombosis,
  4. A history of deep vein thrombosis and pulmonary embolism,
  5. Orthostatic hypotension
  6. Resistant hypertension,
  7. Peripheral nerve lesions such as polyneuropathy, radiculopathy
  8. Active inflammatory, rheumatologic or infectious disease,
  9. Ankle,knee or hip joint contracture,
  10. Presence of panic attacks,
  11. Patients with dizziness and balance problems,
  12. Patients with not intact skin surface to connect electrodes
  13. Patients with communication problems: aphasia, major depression
  14. Epilepsy
  15. Patients who received botulinum A toxin in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: whole body vibration
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
The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
Other Names:
  • 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 same as WBV in the treatment group ).
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 Names:
  • Sham WBV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spasticity-torque
Time Frame: 4 weeks
Spasticity will be measured as a torque. The unit is Nm
4 weeks
spasiticity-modified Ashworth scale
Time Frame: 4 weeks
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)
Time Frame: 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
4 weeks
Motor neuron activity-Hmax / Mmax ratio
Time Frame: 4 weeks
Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Ayşenur Bardak, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPMRTRH-BMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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