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

Not Applicable

Completed

• Conditions: Muscle Spasticity; Physiology
• Interventions: Device: Real vibrator; Device: Sham vibrator

• Registration Number: NCT03916770
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-08-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-08-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
whole body vibration	Real vibrator	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)
Sham whole body vibration	Sham vibrator	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 ).

Primary Outcome Measures

Name	Time	Method
spasticity-torque	4 weeks	Spasticity will be measured as a torque. The unit is Nm
spasiticity-modified Ashworth scale	4 weeks	The spasticity degree of the plantar flexors will be evaluated by using a subjective assessment method (modified Ashworth scale-MAS)
Motor neuron activity-Hmax / Mmax ratio	4 weeks	Hmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool
spasticity-homosynaptic post-activation depression (HPAD)	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

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital Istanbul, Turkey; 🇹🇷 Istanbul, Turkey