Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency (FRM)
Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency
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.
研究概览
详细说明
* 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
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Hauts-de-Seine
-
Garches、Hauts-de-Seine、法国、92380
- Djamel Bensmail
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Cognitive troubles.
- Progressive diseases: Tumoral, infectious, inflammatory and associated pathologies: brain injury, amputation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Using of instrumented wheel and ergometer roller
The same patient will receive two types of tests: instrumented wheel and ergometer roller.
|
Using of instrumented wheel
Using of ergometer roller
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mechanical power calculated by instrumented wheel and ergometer roller.
大体时间：20 min
|
Comparison between mechanical power calculated by the instrumented wheel and mechanical power calculated by ergometer roller.
|
20 min
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Efficient fraction of total power calculated using instrumented wheel
大体时间：6 min
|
Tangential power / total power
|
6 min
|
|
Efficient fraction of total power calculated using ergometer roller
大体时间：15 min
|
Tangential power / total power
|
15 min
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physiological parameters using instrumented wheel
大体时间：6 min
|
Heart rate, VO2 and Borg score.
|
6 min
|
|
Physiological parameters using ergometer roller
大体时间：15 min
|
Heart rate, VO2 and Borg score.
|
15 min
|
合作者和调查者
调查人员
- 首席研究员：Djamel Bensmail, MD、Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE, 92380 Garches, France
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- P101006
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