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临床试验/NCT04134806
NCT04134806Unknown不适用

Evaluation of a Navigation Experiment in the Gait Real-Time Analysis Interactive Lab: Gait Analysis by Induced Disorientation in a VR Environment

University Medical Center Rostock1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Spatial disorientation

研究概览

简要总结

The aim of the study is to investigate whether the effect of disorientation on physical motion and gait among dementia patients, can be reliably measured in a laboratory environment, by means of a virtual reality (VR) experimental setup.

详细描述

Challenges in wayfinding and orientation are early symptoms of MCI and dementia. These deficits decrease mobility which again leads to further cognitive decline. In a field study, we developed a pattern recognition model of disorientated behaviour based on accelerometric data. However, it is questionable if phases of disorientation also affect gait parameters. Furthermore, there is growing evidence that impaired cognitive functioning is associated with changes in gait performance, e.g. gait variability, measured in dual-task walking conditions. Increases in heart rate and skin conductance have also been reported during instances of disorientation.

Hence, We implemented a 3D environment of a familiar city centre in the GRAIL, which combines a fully instrumented treadmill with a synchronized VR environment. We record gait parameters through the motion capture system, and accelerometric and physiological data using wearable sensors (movisens), for comparability with the SiNDeM field study. Young and old healthy adults will participate in the first phase of the study, while Mild dementia or MCI patients will participate in the later phases. Phases of disorientation will be induced by changing the virtual environment.We aim to assess gait, accelerometric and physiological parameters during instances of disorientation, using the GRAIL (Gait Real-Time Analysis Interactive Lab, Motekforce Link).

The results will further enable the automatic detection of disorientation based on gait parameters, physiological and accelerometric data. This is necessary for the development of a situation-aware assistive system which supports persons with dementia in autonomous outdoor mobility.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Within the required age bracket

排除标准

  • Other neurological conditions besides dementia
  • Inability to understand task instructions, deaf-mute, blindness

结局指标

主要结局

Spatial disorientation

时间窗: Up to 3 years from start of the study

Incidences of disorientation will be captured in a video record during the experiment, and then later identified in an off-line annotation procedure using a customized annotation scheme

次要结局

  • Gait variability(Up to 3 years from start of the study)
  • Spatial orientation ability(Up to 3 years from start of the study)
  • Heart rate variability(Up to 3 years from start of the study)
  • Memory function(Up to 3 years from start of the study)
  • Accelerometery(Up to 3 years from start of the study)
  • Executive function(Up to 3 years from start of the study)
  • Skin conductance(Up to 3 years from start of the study)
  • Apolipoprotein E4 status(Up to 3 years from start of the study)
  • Visuospatial function(Up to 3 years from start of the study)

研究者

发起方
University Medical Center Rostock
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Teipel

Prof. Dr.

University Medical Center Rostock

研究点 (1)

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