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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Physiology Device: Sham vibrator Device: Real vibrator Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
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
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Spasticity [ Time Frame: 4 weeks ]
    Spasticity will be measured as a torque. The unit is Nm


Secondary Outcome Measures :
  1. 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)


  2. 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.



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Turkey
Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Study Chair: Ayşenur Bardak, Prof Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publications:
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Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03916770    
Other Study ID Numbers: IstPMRTRH-BMR
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
muscle
vibration
H reflex
H/M ratio
spasticity
Additional relevant MeSH terms:
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Muscle Spasticity
Hemiplegia
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Paralysis