An interventional study of Whole body vibration and Exersice in Brain Injuries and Minimally Conscious State, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 10 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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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 · Other: Exersice
The control group performed the same session without vibration.
Other: Exersice
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.
Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees.
Cerebral cortex activity
Cerebral cortex activity was measured based on changes in oxygenated hemoglobin concentration using fNIRS
Time frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
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: 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.
Time frame: 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 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
Time frame: session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up)
Started Jan 2017 (actual). Primary completion is estimated for Dec 2020, 47 months after the start.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 47 months is above that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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