Prevention of Orthostatic Hypotension With Electric Stimulation in Persons With Acute SCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- blood pressure [mmHg]
研究概览
简要总结
Background:
The presence of orthostatic hypotension (OH) as a consequence of blood volume redistribution during verticalisation in persons with spinal cord injury (SCI) is a common condition.
Aims:
To investigate the impact of three different types of electric stimulation (ES) (ES of the abdominal muscles versus ES of lower limb muscles versus simultaneously ES of abdominal and lower limb muscles versus control) on blood pressure stabilization and verticalisation-degrees between 0° and 70°. The hypothesis is, that the ES-induced contractions of the muscles cause a stabilisation respectively an increase of the blood pressure during the tilt-table test.
Subjects:
20 Women and men, at least 18 years of age, following an acute and traumatic SCI, with a lesion level above T6, an American Spinal Injury Association (AIS) Impairment Scale A,B or C and a diagnosis of OH (by tilt table test) were eligible for the study.
Methods:
Each patient underwent randomly three different types of ES sessions while being positioned on a tilt-table. The following sessions were planned:
A) ES of the abdominal muscles B) ES of the lower limb muscles C) Combination of A and B D) Control session (=diagnostic session)
Study type: Intervention Design: Prospective interventional study
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inpatients
- •positive diagnosis of OH
- •acute traumatic SCI
- •lesion level above T6
- •AIS A, B or C
排除标准
- •fractures of the lower limbs
- •decubitus (NPUAP >2)
- •massive psychiatric dysfunction
- •suicide intention
结局指标
主要结局
blood pressure [mmHg]
时间窗: 1 day (single measurement at each arm )
次要结局
- Heart rate(1 day (single measurement at each arm ))