Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Cerebral cortex activity
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Whole body vibration (Device)
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.
Intervention: Exersice (Other)
Exercise only group
The control group performed the same session without vibration.
Intervention: Exersice (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Coma Recovery Scale-Revised(session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up))
- Modified Ashworth scale(session 0 (initial visit); session 6 (at approximately 6 days); at 2 weeks (follow-up))