Effects of Whole-body Vibration Exercise on Cortical Activity and Consciousness Level in Brain Injury Patients With Minimally Conscious State: Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cerebral cortex activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Exersice (Other)
Exercise only group
The control group performed the same session without vibration.
干预措施: Exersice (Other)
结局指标
主要结局
Cerebral cortex activity
时间窗: 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
次要结局
- 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))