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

Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injuries; Minimally Conscious State
• Intervention / Treatment: Device: Whole body vibration; Other: Exersice

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Su-Hyun Lee, Msc; Phone Number: +82-10-7147-0433; Email: suhyunlee0811@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.

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	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coma Recovery Scale-Revised	assess patients with a disorder of consciousness, commonly coma The CRS-R consists of 23 items, grouped into 6 sub-scales: .Auditory; Visual; Motor; Oromotor; Communication; 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.	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Modified Ashworth scale	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; 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; More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; Considerable increase in muscle tone, passive movement difficult; Affected part(s) rigid in flexion or extension	session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Unconsciousness; Consciousness Disorders; Brain Injuries; Wounds and Injuries; Persistent Vegetative State
• Other Study ID Numbers: 2016-04-101-004

Drug and device information, study documents

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