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Spatial NavigationNCT04074655

Investigating the Effect of Training With a Virtual Reality Driving Simulator

A study testing Driving Simulator in a Virtual Reality Environment in people with Spatial Navigation and Navigation, Spatial, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Spatial Navigation, Navigation, Spatial, Dementia
What is being tested?
Driving Simulator in a Virtual Reality Environment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
10 Sep 2019to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Lindenwood Manor

    Winnipeg, Manitoba, R3P1N3

Other trials in Canada

About this study

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

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).

Read more

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.

Read the detailed 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

Being tested
Driving Simulator in a Virtual Reality Environment
Keywords
Driving Simulator, Virtual Reality
Medical subject headings
Spatial Navigation, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Driving Simulator in a Virtual Reality EnvironmentDevice

    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.

Study groups in NCT04074655
Study groupRoleWhat they receive
Intervention ArmExperimentalParticipants of the study will play the driving simulator daily (5 days/week) for 15-20 minutes/day over a period of 2 consecutive weeks.
Receives: Device: Driving Simulator in a Virtual Reality Environment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (3)

  1. 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.

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

  2. 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).

    Measured: First session of the exercise and Intervention (end of 2-week exercise)

  3. 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).

    Measured: Intervention (end of 2-week exercise)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start10 Sep 2019
  3. Primary completion1 Jan 2020
  4. Study completion1 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074655
Sponsor's protocol ID
B2019:073
Status last verified
Jul 2019
First submitted
26 Aug 2019
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Still has not been decided to share Individual Participant Data (IPD) with other researchers or not.

Publications

  • Masoumzadeh S, Moussavi Z. Does Practicing with a Virtual Reality Driving Simulator Improve Spatial Cognition in Older Adults? A Pilot Study. Neurosci Insights. 2020 Nov 3;15:2633105520967930. doi: 10.1177/2633105520967930. eCollection 2020.

    PubMed 35174332

Questions about this trial

What is this clinical trial studying?

A study testing Driving Simulator in a Virtual Reality Environment in people with Spatial Navigation and Navigation, Spatial, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The ratio between the total trajectories and the trajectories in the correct quadrant (Morris water virtual reality test) (time frame: Baseline and Intervention (end of 2-week exercise)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074655, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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