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临床试验/NCT04074655
NCT04074655已完成不适用

Investigating the Effect of Training With a Virtual Reality Driving Simulator on Orientation Skills in Individuals With Some Memory Impairments

University of Manitoba2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test)

研究概览

简要总结

The proposed study aims to investigate the use of a driving simulator in a virtual reality (VR) environment to improve the cognition state and spatial navigation of individuals with mild/moderate memory impairment.

All volunteers will be assessed by the Montreal Cognitive Assessment (MoCA),Montgomery-Asberg Depression Scale (MADRS) and Morris Water orientation tests for baseline assessment after they sign the consent form and are enrolled into the study. Participants will also be scheduled for post-intervention assessments (MADRS, Morris Water Orientation and a simple questionnaire on how they evaluate the experiment).

Participants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks. Participants' daily performance data are recorded and uploaded on the secure server of the Priciple Investigator (PI).

Simulator Sickness Questionnaire (SSQ) test will also be run after the first session of the experiment and at the end of the training period.

详细描述

After obtaining their consent and enrolling into the study, participants of the study will commit themselves to use the driving simulator daily (5 days/week), and 15-20 minutes/day for a period of 2 consecutive weeks. The location for these simulation sessions will be one of the Family rooms of the Lindenwood Retirement Community. During the experiment, the research assistant (RA) of the study will be present and monitor participants for any plausible simulator sickness. In case if a participant presents any simulator sickness symptom, the experiment will be stopped and the RA will remain with the participant until s/he feels alright to go back to his/her room or with a caregiver. The RA and PI may withdraw the participant from the study if it is for their benefit.

Participants' performance data and the duration of which they practice are all being recorded and uploaded on the secure server of the PI. After the end of the 2-week exercise program, participants will be assessed again by Morris Water orientation test, SSQ, and MADRS; SSQ test will also be run after the first session of the experiment.

Furthermore, their feedback about using the driving simulator will be collected through a

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test)

时间窗: Baseline and Intervention (end of 2-week exercise)

Spatial orientation virtual reality experiment equivalent to Morris water test as primary outcome measure. This test is one of the PI's team designs used in a previous study (B2016:073), which is the VR replica of the standard Morris Water test; and will be run at baseline and at the end of trial (post-intervention). In this test participants sit behind a computer monitor and they move within a virtual maze to reach a particular target. They will do this test using the laptop screen. The test has 5 trials, and participants' trajectory to reaching the target is recorded. The ratio between the total trajectories and the trajectories in the correct quadrant, quadrant of which the target is placed in, is reported as the error of participant trying to find the target.

次要结局

  • MADRS assessment(Baseline and Intervention (end of 2-week exercise))
  • Satisfaction questionnaire(Intervention (end of 2-week exercise))
  • SSQ questionnaire(First session of the exercise and Intervention (end of 2-week exercise))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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