Investigating the Effect of Training With a Virtual Reality Driving Simulator

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074655
• Other study ID #: B2019:073
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2019
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

We will recruit up to 30 volunteers with mild/moderate memory impairment. Inclusion/Exclusion Criteria

• Age: 50+ years

• Have a score of 7< MoCA < 25

• Except the MCI/Alzheimer's diagnosis, have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, Huntington disease, Amyotrophic Lateral Sclerosis (ALS), Multiple sclerosis (MS), and/or any other neurological disorder.

• Fluency in reading/understanding English

Furthermore, in this study we do not need to label participants as healthy or demented; we only use the MoCA range between 7 to 25 to enroll participants. Many healthy adults do have some memory impairments and have a MoCA score less than 25 but still consider themselves healthy. Thus, we do not label anyone in this study as healthy or demented.

Related Conditions & MeSH terms

• Dementia
• Navigation, Spatial
• Spatial Navigation

Intervention

Device:
• Driving Simulator in a Virtual Reality Environment
Driving simulator in virtual reality environment is a game with the several level of difficulty and the goal of improving the cognition level of participants in general and their spatial cognition in particular. Moreover this game, will have a positive effect on its users' mood as well.

Locations

Country	Name	City	State
Canada	Lindenwood Manor	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test)	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.	Baseline and Intervention (end of 2-week exercise)
Secondary	MADRS assessment	Montgomery-Asberg Depression Scale (MADRS) to measure depression as a confounding variable.; The MADRS is a ten item rating scale for rating levels of depression. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates absence of the symptom and 6 indicates extreme presence of the symptom. So, the maximum raw score of the test will be 60. The raw score reported more than 10, indicates the possible presence of depression. The time frame for the scale is the previous four weeks.	Baseline and Intervention (end of 2-week exercise)
Secondary	SSQ questionnaire	Simulator Sickness Questionnaire (SSQ) to assess the plausible motion sickness due to using the driving simulator.; The SSQ is a sixteen item questionnaire for rating the severity of most common symptoms associated with motion sickness, nausea and oculo-motor problems, experienced by users of virtual reality systems. Each item is rated on a 4-point scale from 0 to 3, where 0 indicates absence of the symptom and 3 indicates the symptom being severe. The total raw score reported by the questionnaire is 48, and the higher the reported score the more severe the symptoms experienced due to simulation sickness. The SSQ will be run after the first session of using the driving simulator and at the end of the trial (post-intervention).	First session of the exercise and Intervention (end of 2-week exercise)
Secondary	Satisfaction questionnaire	Short questionnaire to assess the level of satisfaction after using the driving simulator to collect participants' general feedback on the experiment.; This is a short questionnaire consisting of 3 questions for rating the level of participants' satisfaction after using the driving simulator. Each item is rated on a 10-point scale from 1 to 10, representing from low to high satisfaction levels. The total raw score for the questionnaire is 30, and the higher the score, the higher the level of the satisfaction after using the driving simulator. This test will be run at the end of the trial (post-intervention).	Intervention (end of 2-week exercise)