Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale
研究概览
简要总结
The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
详细描述
The objective of the study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.
The study consists of three distinct and independent phases:
- Phase 1: Performance evaluation on wheelchair ergometer in order to compare the energy expenditure and kinetic characteristics in comparable situations with regard to speed and workload imposed to the wheelchair-patient couple.
- Phase 2: Comparison of maneuverability and ease of crossing usual obstacles in outdoor and indoor paths with standardised obstacles. Trajectories are to be recorded in order to allow analysis by independent experts.
- Phase 3: Comparison of the autonomy of patients afforded by the devices by comparing the patient's ability to transfer from wheelchair to car seat and from car seat to wheelchair, as well as ease of wheelchair packing in car, in the context of a standard city transport involving a car and the wheelchair.
The three phases are to be performed using the standard manual wheelchair and the three assisting devices in a randomized order.
Three different groups of patients are included in the three phases of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 70 years
- •Spinal cord injury C5-C8, paraplegic D1-D11, and D11 paraplegic below only for phases 1 and 2 phase 1 and 2
- •Spinal cord injury D1 and above only for phase 3
- •Having given free and informed consent
- •Negative pregnancy test for women of childbearing age
排除标准
- •No affiliation to a social security scheme
- •Refusal to participate in the clinical trial
- •Patient under guardianship
- •Major cognitive disorders
- •Functional abnormality of the shoulder
- •History of cardiovascular disease
- •ECG to suspect coronary insufficiency
- •Pregnant patients without effective treatment or contraceptive
- •Acute complication or systemic organ
结局指标
主要结局
Phase 2: Ease of crossing obstacles assessed by patients with a Visual Analog Scale
时间窗: 3 hours
Phase 3: Time necessary to transfer from wheelchair to car and from car to wheelchair.
时间窗: 3 hours
Phase 1: physiological parameters : Oxygen consumption.
时间窗: 3 hours
次要结局
未报告次要终点