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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
Sponsor:
Information provided by (Responsible Party):
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date August 17, 2020
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Spasticity [ Time Frame: 4 weeks ]
Spasticity will be measured as a torque. The unit is Nm
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia
Official Title  ICMJE The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research
Brief 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, 2 days a week, a total of 8 sessions with the WBV powerplate pro5 device.(Vibration frequency: 30 Hertz(Hz), amplitude: 2.2 mm and duration 1x10 seconds (starting period) + 3x30 seconds).The Sham control group (n=24) will have 8 sessions WBV in total, the same time,.with the same frequency but 99.5% weakened amplitude.The surface Electromyography (EMG) and degree of spasticity of soleus muscle will be evaluated at the beginning and end of the all sessions. Soleus T-reflex and 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. To obtain T reflex response, an electronic reflex hammer (Elcon 100-150 Germany) will be used.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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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: Single (Participant)
Masking Description:
Patients will be blind to treatment
Primary Purpose: Treatment
Condition  ICMJE
  • Muscle Spasticity
  • Physiology
Intervention  ICMJE
  • 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
  • Device: Real vibrator
    The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
    Other Name: Real WBV
Study Arms  ICMJE
  • 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).
    Intervention: Device: Real vibrator
  • 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).
    Intervention: Device: Sham vibrator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2019)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ischemic / hemorrhagic poststroke hemiplegia
  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 one minute and had a static balance

Exclusion Criteria:

  1. Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease)
  2. The presence of 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. Having joint contracture,
  10. Having a history 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916770
Other Study ID Numbers  ICMJE IstPMRTRH-BMR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Sponsor  ICMJE Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ayşenur Bardak, Prof Istanbul Physical Medicine Rehabilitation Training and Research Hospital
PRS Account Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP