Effects of Whole-body Vibration Exercise on Stroke Patients

NCT ID: NCT03375346

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-04

Study Completion Date

2017-08-03

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.

Conditions

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Stroke Hemiplegia

Keywords

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Whole body vibration exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Whole body vibration

Intervention Type DEVICE

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.

Exercise

Intervention Type OTHER

maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

Exercise only group

The control group performed the same session without vibration.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

Interventions

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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.

Intervention Type DEVICE

Exercise

maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees

Intervention Type OTHER

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun-Hee Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

References

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Lee A, Kim H, Kim J, Choi DS, Jung JH, Lee J, Kim YH. Modulating Effects of Whole-body Vibration on Cortical Activity and Gait Function in Chronic Stroke Patients. Brain Neurorehabil. 2020 Mar 26;13(2):e12. doi: 10.12786/bn.2020.13.e12. eCollection 2020 Jul.

Reference Type DERIVED
PMID: 36744184 (View on PubMed)

Other Identifiers

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2015-07-092

Identifier Type: -

Identifier Source: org_study_id