Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Mechanical power calculated by instrumented wheel and ergometer roller.
研究概览
简要总结
The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.
The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.
详细描述
* The manual wheelchair is used by people for whom walking is difficult or impossible due to spinal cord lesions, neurological and muscular diseases, lower limb trauma, age ...etc.
Although the wheelchair help to regain mobility, this made of displacement is nor natural nor well-to-do.
- The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the instrumented wheel, adaptable with all wheelchairs, with information wireless transmission.
- The primary objective of study is to validate the instrumented wheel of manual wheelchair such as a new device of evaluation of capacities of displacement in ecologic situation.
- The primary criteria is to compare the mechanical power calculated using instrumented wheel versus the power calculated using ergometer roller during protocol of standard cardio-respiratory stress test.
This study is interventional, mono-centric, controlled and crossover. The population concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.
Number of subjects projected for the entire study: 62 patients The total duration of participation of each patient: 7 days ±2days
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Age : 18-70 years.
- •Spinal cord injured patient.
- •User of manual wheelchair for daily locomotion (having at least 30/100 at displacement items of WST questionnaire) .
- •Affiliation to a social security scheme or entitled.
- •Informed consent dated and signed by subject or subject's legally acceptable representative (and investigator).
排除标准
- •Cognitive troubles.
- •Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
研究组 & 干预措施
Using of instrumented wheel and ergometer roller
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
干预措施: Using of instrumented wheel (Device)
Using of instrumented wheel and ergometer roller
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
干预措施: Using of ergometer roller (Device)
结局指标
主要结局
Mechanical power calculated by instrumented wheel and ergometer roller.
时间窗: 20 min
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
次要结局
- Efficient fraction of total power calculated using instrumented wheel(6 min)
- Efficient fraction of total power calculated using ergometer roller(15 min)