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临床试验/NCT01171287
NCT01171287已完成不适用

Effects of Right Lower Limb Orthopedic Immobilization on Braking Function : An On-the-Road Experimental Study by Healthy Volunteers

Université de Sherbrooke4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
4
主要终点
Braking performances during real-time driving.

研究概览

简要总结

Research on the implications of orthopedic injury and surgery on automobile driving ability has been limited. Only a handful of orthopedic issues have been studied to date, especially the safe postoperative resumption of driving. However, effects of orthopedic immobilizations of the lower right limb on fitness to drive are largely unknown, and the physician is left with little guidance. Only one study (Tremblay et al. 2009) have looked at the impact of wearing such devices on braking performances. The results have shown a statistically significant increase of braking times while wearing a removable Aircast walker and a walking cast in healthy subjects under simulated driving conditions. Despite this, the study have not demonstrated that driving with orthopedic immobilization is dangerous since the increase in braking times were minimal. Limitations of this study include the important fact that driving simulation is not real-time driving. In order to assess the validity of the driving simulator used in this study, a similar experimental study during real-time driving was thus devised.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects between 25 to 60 years old
  • Possession of a valid Quebec driver's license
  • Driving for at least 5 years
  • Exclusively use the right foot for accelerating and braking

排除标准

  • Visual acuity deficits or other visual problems uncompensated
  • History of drug or alcohol abuse
  • Use of psychotropic drugs
  • Any illness of the central nervous system such as epilepsy
  • Sleep disorders
  • Metabolic problems
  • Cardiovascular disease
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Psychiatric illness
  • Renal disease
  • Musculoskeletal disease
  • Motion sickness

结局指标

主要结局

Braking performances during real-time driving.

时间窗: Two years.

The braking performances are assessed using (1) the median foot movement time, (2) the median brake reaction time and (3) the median total braking time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francois Cabana

Doctor

Université de Sherbrooke

研究点 (4)

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