Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
研究概览
简要总结
The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials).
Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury.
- Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.
详细描述
Design: Prospective controlled non-randomized study. Materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
- Gait training in the tilt table with integrated stepping system(20 min).
- Control measurement of EEG and ERP Effect parameters: se outcome measures. Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.
Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior).
Significance level is set to 0.05 for all effect parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Goup:
- •Severe Brain Injury
- •Ongoing Impaired State of Consciousness (RLAS<4)
- •Stable Vital Functions
- •Written Consent from Relatives/Legal Guardian
- •Control Group:
- •No History of Neurological Diseases in the Past
- •Age over 18 years
- •Written Consent -
排除标准
- •Patient and Control Goup:
- •Age older than 80 years
- •Other Neurological Diseases
- •Lack of BAEP
- •Severe Co-morbidity
- •Tilt table contraindications: orthostatic circulatory problems, unstable fractures, severe osteoporosis, sken problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (psychotic illnesses or neurotic disturbances), adjustment problems (i.e. integrated stepping system cannot be safely adjusted to the patient)
研究组 & 干预措施
P-T
干预措施: Tilt Table With Integrated Stepping System (Behavioral)
P- SAH
干预措施: Tilt Table With Integrated Stepping System (Behavioral)
P- A
干预措施: Tilt Table With Integrated Stepping System (Behavioral)
Control
干预措施: Tilt Table With Integrated Stepping System (Behavioral)
结局指标
主要结局
EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
时间窗: immediately after the end og the training
次要结局
- EEG: absolute and relative power in every frequency band; median frequency;(immediately after the end of the training)