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Completed

NCT Number: NCT03916770

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham vibrator

Device

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

Real vibrator

Device

The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position

Other names: Real WBV

Primary outcomes

  1. spasticity-torque

    Time frame: 4 weeks

    Spasticity will be measured as a torque. The unit is Nm

  2. 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)

  3. 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. 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

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Acronym: WBV

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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