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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole body vibration group | Experimental | 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. |
|
| Exercise only group | Active Comparator | The control group performed the same session without vibration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body vibration | 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. |
| 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) |
| 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:
The total score ranges between 0 (worst) and 23 (best). This measure takes a minimum of 25 minutes to complete. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun-Hee Kim, MD, PhD | Contact | 82-2-3410-2824 | yunkim@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yun-Hee Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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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.
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| Exersice | Other | Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees. |
|
| 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
| session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up) |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001925 | Brain Damage, Chronic |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |