Effects of Whole-body Vibration Exercise on Stroke Patients

Not Applicable

Completed

• Conditions: Hemiplegia; Stroke
• Interventions: Device: Whole body vibration; Other: Exercise

• Registration Number: NCT03375346
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2015-08-04
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-03
• Status Verified: 2017-12
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Unilateral stroke with hemiplegia
• 3 months after stroke onset
• Able to walk at least 10 meters without assistive devices

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Whole body vibration group	Whole body vibration	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.
Exercise only group	Exercise	The control group performed the same session without vibration.
Whole body vibration group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Cerebral cortex activity	check before, during and directly after intervention(for approximately 14 minutes)	cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS

Secondary Outcome Measures

Name	Time	Method
10 meter walk test	before and after intervention(Approximately 14 minutes)	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.
Fugl-Meyer Assessment	before and after intervention(Approximately 14 minutes)	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.
Timed up and go test	before and after intervention(Approximately 14 minutes)	test for gait speed and gait balance
Tinetti Performance Oriented Mobility Assessment	before and after intervention(Approximately 14 minutes)	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)