European Multicentre Study of Human SCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- Walking Index for Spinal Cord Injury (WISCI)
研究概览
简要总结
Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with SCI at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. Therefore, several European Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a close collaboration for standardised assessment. The aim is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and to bring new standardised assessment tools to the clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single event traumatic or ischemic para- or tetraplegia
- •First EMSCI assessment possible within the first 6 weeks after incidence
- •Patient capable and willing of giving written informed consent
排除标准
- •Nontraumatic para- or tetraplegia (i.e. discusprolaps, tumor, AV-malformation, myelitis) excl. single event ischemic incidences
- •Pre-known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
- •Peripheral nerve lesions above the level of lesion (i.e. plexus brachialis impairment)
- •Pre-known polyneuropathy
- •Severe craniocerebral injury
结局指标
主要结局
Walking Index for Spinal Cord Injury (WISCI)
时间窗: Change in course from 2 weeks at 48 weeks
Score from 0 to 20; the higher the score, the better the walking ability of the patient
10 Meter Walk Test (10mWT)
时间窗: Change in course from 2 weeks at 48 weeks
Spinal Cord Independence Measure (SCIM)
时间窗: Change in course from 2 weeks at 48 weeks
Score from 0 to 100 points; the higher the score, the higher the independence of the patient
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score)
时间窗: Change in course from 2 weeks at 48 weeks
Score from 0 to 112; the higher the score, the better the neurological status of the patient
次要结局
未报告次要终点