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临床试验/NCT02644213
NCT02644213Unknown不适用

Evaluation of Physical and Cognitive Performance After Simulated Road March Combines Physical and Cognitive Load Using a Virtual Reality Environment

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
executive function

研究概览

简要总结

The aim of the research is to evaluate the influence of physical and cognitive load as pre-mission activity on the soldier's physical and cognitive performance, in compare to physical load alone.

In order to do so, 12 healthy subjects will perform stimulated road march using a virtual reality environment combined with cognitive load and without, and their physical and cognitive performance will be evaluated by tests before and after.

详细描述

12 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test.

Afterwards, the subjects will perform randomly 3 experimental days, each consist of physical and cognitive performance evaluation before and after simulated road march using a virtual reality environment; once without additional load, once combining cognitive load during the road march, and once without physical load (without march, waiting between evaluations) as control.

The experiment will take place in a dome room, and the systems being used are:

  1. CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome.
  2. MOTEK (Motek Medical©, the Netherlands) which is a two track treadmill (for each leg) placed on a rotatable platform.

cognitive tasks for example: navigation, identification and remembering cars/aircraft.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • aged 18-30
  • healthy civilians volunteers
  • with no background illnesses
  • with history of combat unit service in the IDF.
  • fit to perform 10 Km moderate march while carrying load.

排除标准

  • The existence or suspicion of existing cardiac or respiratory disease.
  • Hypertension.
  • Diabetes.
  • Any muscles or skeleton condition.
  • Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
  • Infectious disease 3 days prior to the experiment.

研究组 & 干预措施

research arm

Experimental

12 young, healthy civilian volunteers will participate in this study. The experiment will take place in a dome room.

The experiment will be performed according to the protocol of using CAREN and MOTEK systems:

  1. CAREN high (Computer Assisted Rehabilitation Environment) which screens virtual scene in the dome.
  2. MOTEK (Motek Medical©, the Netherlands) which is a two track treadmill (for each leg) placed on a rotatable platform.

each subject will undergo the same experiment protocol.

干预措施: protocol of using CAREN and MOTEK systems (Other)

结局指标

主要结局

executive function

时间窗: 3 experimental days

executive function will be evaluated based on the validated Trail Making Test (TMT).

cognitive performance (composite)

时间窗: 3 experimental days

grade will be calculated according to the subject's performance in the computerized tests (SYNWIN activity research services) at the virtual reality environment . performance evaluation is based on the parameters: concentration, memory, visual perception, data processing capability, response time and multitasking.

次要结局

  • heart rate variability(3 experimental days)
  • lactic acid(3 experimental days)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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