Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State

NCT ID: NCT03389113

Last Updated: 2019-09-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-02

Study Completion Date

2020-12-31

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 consciousness Level in brain injury patients with minimally conscious state.

Detailed Description

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Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise in brain injury patients with minimally conscious state.

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 assessment were performed using the coma recovery scale-revised and modified ashworth scale.

Conditions

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Brain Injuries Minimally Conscious State

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 five sessions 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 sessions without vibration.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Whole body vibration group

Whole body vibration group performed five sessions 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.

Exersice

Intervention Type OTHER

Exercise 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

Exersice

Intervention Type OTHER

Exercise 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

Exersice

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

* Patients whose consciousness level was assessed as minimally conscious state by traumatic brain injury, stroke, and hypoxic brain injury
* Patients who had more than 3 months after brain injury

Exclusion Criteria

* Patients under 18 years of age and older patients over 80 years
* Pregnant women
* In cases of uncontrolled internal or external disease
* Patients with severe heart, musculoskeletal problems and disabilities, and those with severe neurological lesions prior to brain injury
* Acute or chronic venous thrombosis or hemorrhage
* Person wearing an implant on the spine
* People with severe osteoporosis
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

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yun-Hee Kim, MD, PhD

Role: CONTACT

82-2-3410-2824

Facility Contacts

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Su-Hyun Lee, Msc

Role: primary

+82-10-7147-0433

Other Identifiers

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2016-04-101-004

Identifier Type: -

Identifier Source: org_study_id

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