Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population
研究概览
简要总结
Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.
详细描述
- inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
- 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
- return visit : device return, agenda return, skin control, seat-pressures control
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
- Prevention
- 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
- •Patient is male or female, aged ≥ 18
- •Patient accepting the initial assessment and the following visits during the protocol
- •Written informed consent has been obtained
- •Patient having a social assurance
- •Spinal cord injury ≤ C6 stable Spinal cord trauma > 1 an
- •Main mode of ambulation : own manual wheelchair
排除标准
- •Aged ≤ 18
- •Adults under guardianship
- •Patients do not speak French, refusing or unable to be followed
- •Pregnant or lactating women
- •Person deprived of their liberty by judicial or administrative decision
- •Person hospitalised without consent
- •Pelvic pressure ulcer ongoing
- •Cognitive disorder incompatible with the use of the device, understanding and conduct of the study
结局指标
主要结局
Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population
时间窗: 4 weeks
Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure
次要结局
- Intra- and inter-patients variability of stored pressures for subpopulations(4 weeks)