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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389113
Recruitment Status : Unknown
Verified December 2017 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : January 3, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Injuries Minimally Conscious State Device: Whole body vibration Other: Exersice Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
Actual Study Start Date : January 2, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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: Exersice
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: Exersice
Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees.


Outcome Measures
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Primary Outcome Measures :
  1. Cerebral cortex activity [ Time Frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up) ]
    Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS


Secondary Outcome Measures :
  1. Coma Recovery Scale-Revised [ Time Frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up) ]

    assess patients with a disorder of consciousness, commonly coma

    The CRS-R consists of 23 items, grouped into 6 sub-scales:

    1. .Auditory
    2. Visual
    3. Motor
    4. Oromotor
    5. Communication
    6. Arousal The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input.

    The total score ranges between 0 (worst) and 23 (best). This measure takes a minimum of 25 minutes to complete.


  2. Modified Ashworth scale [ Time Frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up) ]

    measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity The Ashworth scale is one of the most widely used methods of measuring spasticity, due in a large part to the simplicity and reproducible method.

    0: No increase in muscle tone Grade Description

    1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389113


Contacts
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Contact: Yun-Hee Kim, MD, PhD 82-2-3410-2824 yunkim@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Su-Hyun Lee, Msc    +82-10-7147-0433    suhyunlee0811@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Yun-Hee Kim, MD, PhD Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03389113    
Other Study ID Numbers: 2016-04-101-004
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Persistent Vegetative State
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
 Trauma, Nervous System
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations