Effects of Whole-body Vibration Exercise on Stroke Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Device: Whole body vibration; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whole body vibration group; 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; 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.; Other: Exercise; maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees
Active Comparator: Exercise only group; The control group performed the same session without vibration.	Other: Exercise; maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2015
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): August 3, 2017

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Whole body vibration exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 2015-07-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No