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

Primary Purpose

Muscle Spasticity, Physiology

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sham vibrator
Real vibrator
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Spasticity focused on measuring muscle, vibration, H reflex, H/M ratio, spasticity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

whole body vibration

Sham whole body vibration

Arm Description

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)

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 ).

Outcomes

Primary Outcome Measures

spasticity-torque
Spasticity will be measured as a torque. The unit is Nm
spasiticity-modified Ashworth scale
The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)
spasticity-homosynaptic post-activation depression (HPAD)
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
Motor neuron activity-Hmax / Mmax ratio
Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool

Secondary Outcome Measures

Full Information

First Posted
April 11, 2019
Last Updated
December 27, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03916770
Brief Title
The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia
Acronym
WBV
Official Title
The Effect of Whole Body Vibration on Spasticity in Poststroke Hemiplegia:Prospective Randomized Controlled Research
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. WBV ; reduces plantar flexor spasticity after stroke 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity, Physiology
Keywords
muscle, vibration, H reflex, H/M ratio, spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Patients will be blind to treatment
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
whole body vibration
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Sham whole body vibration
Arm Type
Sham Comparator
Arm Description
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 ).
Intervention Type
Device
Intervention Name(s)
Sham vibrator
Other Intervention Name(s)
Sham WBV
Intervention Description
The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.
Intervention Type
Device
Intervention Name(s)
Real vibrator
Other Intervention Name(s)
Real WBV
Intervention Description
The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
Primary Outcome Measure Information:
Title
spasticity-torque
Description
Spasticity will be measured as a torque. The unit is Nm
Time Frame
4 weeks
Title
spasiticity-modified Ashworth scale
Description
The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)
Time Frame
4 weeks
Title
spasticity-homosynaptic post-activation depression (HPAD)
Description
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
Time Frame
4 weeks
Title
Motor neuron activity-Hmax / Mmax ratio
Description
Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic / hemorrhagic poststroke hemiplegia aged 18-90 years, Stroke time ≥1 months, Ankle plantar flexor spasticity MAS ≥1, Brunnstrom stage ≥3 for lower extremity, Patients who were standing for more than five minutes and had a static balance Exclusion Criteria: Cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease) Lower extremity fracture, Findings or suspicion of active deep vein thrombosis, A history of deep vein thrombosis and pulmonary embolism, Orthostatic hypotension Resistant hypertension, Peripheral nerve lesions such as polyneuropathy, radiculopathy Active inflammatory, rheumatologic or infectious disease, Ankle,knee or hip joint contracture, Presence of panic attacks, Patients with dizziness and balance problems, Patients with not intact skin surface to connect electrodes Patients with communication problems: aphasia, major depression Epilepsy Patients who received botulinum A toxin in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşenur Bardak, Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23035004
Citation
Chan KS, Liu CW, Chen TW, Weng MC, Huang MH, Chen CH. Effects of a single session of whole body vibration on ankle plantarflexion spasticity and gait performance in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Dec;26(12):1087-95. doi: 10.1177/0269215512446314. Epub 2012 Oct 3.
Results Reference
background
PubMed Identifier
23486302
Citation
Pang MY, Lau RW, Yip SP. The effects of whole-body vibration therapy on bone turnover, muscle strength, motor function, and spasticity in chronic stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Aug;49(4):439-50. Epub 2013 Mar 13.
Results Reference
background
PubMed Identifier
29032720
Citation
Miyara K, Matsumoto S, Uema T, Noma T, Ikeda K, Ohwatashi A, Kiyama R, Shimodozono M. Effect of whole body vibration on spasticity in hemiplegic legs of patients with stroke. Top Stroke Rehabil. 2018 Mar;25(2):90-95. doi: 10.1080/10749357.2017.1389055. Epub 2017 Oct 16.
Results Reference
background
PubMed Identifier
22289234
Citation
Brogardh C, Flansbjer UB, Lexell J. No specific effect of whole-body vibration training in chronic stroke: a double-blind randomized controlled study. Arch Phys Med Rehabil. 2012 Feb;93(2):253-8. doi: 10.1016/j.apmr.2011.09.005.
Results Reference
background
PubMed Identifier
30225145
Citation
Alp A, Efe B, Adali M, Bilgic A, Demir Ture S, Coskun S, Karabulut M, Ertem U, Gunay SM. The Impact of Whole Body Vibration Therapy on Spasticity and Disability of the Patients with Poststroke Hemiplegia. Rehabil Res Pract. 2018 May 2;2018:8637573. doi: 10.1155/2018/8637573. eCollection 2018.
Results Reference
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The Effect of Whole Body Vibration (WBV) on Spasticity in Poststroke Hemiplegia

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