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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03916770
Acronym
WBV
Enrollment
48
Registered
2019-04-16
Start date
2019-08-01
Completion date
2020-08-01
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity, Physiology

Keywords

muscle, vibration, H reflex, H/M ratio, spasticity

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

Interventions

DEVICESham vibrator

The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.

DEVICEReal vibrator

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

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patients will be blind to treatment

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
spasticity-torque4 weeksSpasticity will be measured as a torque. The unit is Nm
spasiticity-modified Ashworth scale4 weeksThe 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)4 weeksHomosynaptic 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 ratio4 weeksHmax / Mmax ratio defines motor neuron activity. The higher this ratio, the higher the activity of motor neuron pool

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026