Effects of Whole-body Vibration Exercise on Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

Detailed Description
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Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise. Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

Official Title
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Effects of Whole-body Vibration Exercise on Brain Activity and Physical Function in Hemiplegia Stroke Patients

Conditions
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Stroke, Hemiplegia

Intervention / Treatment
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* Device: Whole body vibration
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke with hemiplegia 3 months after stroke onset Able to walk at least 10 meters without assistive devices Exclusion Criteria: Subjects under 18 years and above 80 years old, Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis) Musculoskeletal disorders Risk of falling due to dizziness Pregnant women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible patients were randomly assigned to one of the two groups in a 1:1 ratio using an odd or even random numbers table. Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. The control group performed the same session without vibration.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole body vibration group<br>Whole body vibration group performed a single session of whole body vibration exercise via a vibrating platform (Galileo® Advanced Plus, Novotec Medical, Pforzheim, Germany) with a magnitude of 20 Hz and an amplitude of 4 mm. | Device: Whole body vibration<br>* whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.<br>Other: Exercise<br>* maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees<br>|
| Active Comparator: Exercise only group<br>The control group performed the same session without vibration. | Other: Exercise<br>* maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral cortex activity | cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS | check before, during and directly after intervention(for approximately 14 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test | performance measure used to assess walking speed in metres per second over a short distance. It can be Blender3D NormalWalkCycle.gifemployed to determine functional mobility, gait, and vestibular function. | before and after intervention(Approximately 14 minutes) | 
| Timed up and go test | test for gait speed and gait balance | before and after intervention(Approximately 14 minutes) | 
| Fugl-Meyer Assessment | a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. | before and after intervention(Approximately 14 minutes) | 
| Tinetti Performance Oriented Mobility Assessment | Task-oriented outcome measure that assesses gait and balance ability; is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B) | before and after intervention(Approximately 14 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole body vibration exercise