NCT04833543Unknown不适用
Verticalization With Vestibular Stimulation for Patients With Severe Disorders of Consciousness: A Novel Application of a Robotic Exoskeleton
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Coma Recovery Scale-Revised (CRS-R)
研究概览
简要总结
Mobilization, specifically verticalization, has been shown to play a role in enhancing consciousness. Vestibular stimulation has the potential to influence the neural substrate of consciousness, but this modality has not been thoroughly explored. The primary aim of this study is to compare the influence of verticalization with and without vestibular input on level of consciousness in patients experiencing disorders of consciousness (DoC).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) following traumatic brain injury (TBI), intracerebral bleeding, ischemic infarction, or hypoxic brain injury
- •Medical clearance by a physician
- •18-75 years old
- •Mobilization into standing for at least 10 minutes without signs of orthostasis
排除标准
- •Time since injury less than 4 weeks or more than 6 months
- •Mobilization into standing lasts more than 30 minutes
- •Severe osteoporosis
- •Muscle tone that prevents joint motion (Modified Ashworth Scale (MAS) 4)
- •Unstable fractures
- •Decubiti on areas contacted by robotic mobility device (i.e. heels, tibia, greater trochanter, ischial tuberosity, sacrum)
- •Inability to fit device requirements*
- •Height 4'8"-6'4", Weight 88-222 lbs., Hip Flexion 0-90˚, Knee Flexion 0-90˚, Plantigrade
结局指标
主要结局
Coma Recovery Scale-Revised (CRS-R)
时间窗: through study completion; an average of 8 weeks
scores range from 0-23; higher scores mean a better outcome
次要结局
- Modified Ashworth Scale (MAS)(through study completion; an average of 8 weeks)
研究者
研究点 (2)
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