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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Brain Injuries, Minimally Conscious State

Intervention / Treatment
-----------------
* Device: Whole body vibration
* Other: Exersice


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

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) |