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Vision, LowRe:GardeNCT05619432

Re:Garde Program - Training and Maintaining Visual Perception in Older Adults

A study testing HMD: Immersive VR in people with Vision, Low and Visual Impairment, run by University Health Network, Toronto at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Seniors deal with considerable visual demands (driving, communicating, traveling) and reduced vision affects their quality of life, ability to enjoy activities, and age-in-place. Vision loss has a heavy, increasing, economical and social burden. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Vision, Low, Visual Impairment
What is being tested?
HMD: Immersive VR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesCanada
Study dates
26 Oct 2023to 27 Jun 2024
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65 years of age or older
  • Have self-reported healthy vision or only self-reported vision issues
  • Can have corrected vision and use glasses/contacts with the VR headset
  • Have access to Wi-Fi if participating from home

Who cannot join

  • Vision impairments (such as glaucoma, macular degeneration, etc.) as diagnosed by a medical professional
  • Cervical conditions, injuries, or open face wounds that would make it unsafe to use the VR headset
  • Cannot speak or understand English

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Perley Health

    Ottawa, Ontario, K1G 5Z6

  • Krembil Research Institute, UHN

    Toronto, Ontario, M5T 0S8

Other trials in Canada

About this study

Official title: VRision Program - Scaling of a Validated Virtual Reality Training Program for Improving Vision in Older Adults

Seniors deal with considerable visual demands (driving, communicating, traveling) and reduced vision affects their quality of life, ability to enjoy activities, and age-in-place. Vision loss has a heavy, increasing, economical and social burden. It can also have substantial impacts on caregivers physically, psychologically, and financially because one tends to miss more work, be less productive, and thus have fewer job opportunities.

This registration will describe the clinical portion of a larger study designed to evaluate both the feasibility and effectiveness of the Re:Garde Program, a Virtual Reality (VR) visual training program for older adults to help maintain visual perception to promote quality of life and prolonged independence. In partnership with our care partners the investigators will implement the Re:Garde Program at an interprofessional clinic and as part of a loaning program for older adults to use in the home.

The clinical portion of this study will look at how effective the Re:Garde program is at maintaining or improving visual perception, ability to conduct activities of daily living (e.g. read, drive, cook, exercise etc.), general wellness, and quality of life. The feasibility of implementing this program in the two settings will be evaluated separately as part of the full protocol.

Read the detailed description

This will be an interventional, pragmatic, pilot study with a target total recruitment of 30 participants (15 per arm). The study duration is 7 weeks. Participants will be assigned to one of two arms: Clinic Setting vs Home Setting.

SCREENING \& BASELINE TEST

At the initial visit in the clinic, participants will be screened for exclusion criteria and practice a condensed version of the immersive VR (IVR) stimulation using the head-mounted display (HMD). Following stimulation participants will be assessed for IVR sensitivity, or cybersickness, using the Virtual-Reality Induced Symptoms and Effects (VRISE) questionnaire. Finally participants will be asked to complete vision tests within the VR headset (for visual attention and cognition) and a series of questionnaires corresponding to visual perception, ability to perform activities of daily living, and quality of life. Participants in the home-arm will take home an HMD along with a package of questionnaires for the duration of the study.

INTERVENTION

Participants of the study will perform their visual training on the HMD every other day for six weeks (21 sessions total). The clinic-arm participants will train at the clinic using the HMD provided. The home-arm participants will train using the HMD on loan to them for the duration of the study.

Each training session (to be completed every other day) will contain three blocks of 15 audiovisual stimulation tasks. Each task lasts for 20 seconds of audiovisual IVR stimulation (3D-Multi Object Tracking + correlated sound). There will be a 2-min break between each of the three blocks of tasks. After each session, the participant will answer the VRISE questionnaire through the HMD. Data from the IVR stimulation and the VRISE score will be sent automatically through Wi-Fi in real-time to a dedicated and secured laboratory computer located at Krembil Research Institute after each session. The total time for the training session should be approximately 15 minutes.

At the mid-point of intervention (end of week 3) participants will repeat the visual tests and questionnaires from baseline.

POST-INTERVENTION

After participants complete their 6-week intervention program they will repeat the visual tests and questionnaires from baseline along with a new questionnaire to evaluate the quality of the VR software in terms of user experience. Subjects participating in the loaning program will schedule a home visit where the VR equipment and questionnaires will be collected at this point. All participants will also be interviewed to collect feedback on their experience with the device, feasibility of the therapy, and overall experience.

Being tested
HMD: Immersive VR
Medical subject headings
Vision, Low, Vision Disorders

What participants receive

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

  • HMD: Immersive VRDevice

    The device application involves the 3D multiple-object-tracking (3D-MOT) paradigm composed of 8 high-contrast spheres which are adapted to the visual ability of participant (luminosity and size). The initial speed of the spheres is adjustable and determined during the inclusion visit.

    STIMULATION:

    One or more of the spheres is temporarily cued (target). Then all spheres move for 20 seconds following random linear paths, bouncing on one another and on the walls of a virtual 3D cube when collisions occur. After 20 seconds, the movement stops and the participant is asked to select, using a laser pointer, the initially cued target(s) among the eight spheres. If the selection is correct the speed of the spheres in the next trial is increased. If the selection is incorrect the speed of the spheres in the next trial is decreased.

    Based on performance, stimulations will be adjusted to change difficulty level (e.g. changing backgrounds, number of cued balls, etc.)

Study groups in NCT05619432
Study groupRoleWhat they receive
Group A: Clinic SettingExperimentalParticipants will complete their virtual reality (VR) visual training program by visiting a local clinic and using the head-mounted display (HMD) provided. Participants will receive initial training on using the device and software and are expected to complete their 6-weeks of visual training independently at the clinic. Additional training and FAQ materials will be available on site for participants to use as reference.
Receives: Device: HMD: Immersive VR
Group B: Home SettingExperimentalParticipants will complete their virtual reality (VR) visual training program from their own homes using a head-mounted display (HMD) that is on loan for the study. Participants will receive initial training on using the device and software at the clinic and will take home the HMD to complete their 6-weeks of visual training independently from home. Additional training and FAQ materials will be given to participants to use as reference.
Receives: Device: HMD: Immersive VR

What is being measured

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

  1. Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS)

    This 19-item questionnaire will ask participants about a series of daily activities that some individuals with visual problems find challenging to perform. These activities are categorized into five subscales (distance vision, near vision, glare disability, night driving, and daytime driving). Each subscale is scored between 0 (inability to perform the activity because of visual difficulty) and 100 (no visual difficulty).

    Measured: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)

  2. Changes from baseline in self-reported independence/autonomy using the Instrumental Activities of Daily Living (IADL) Scale

    This questionnaire will ask participants to rate their degree of independence for eight (8) different common activities of daily living (e.g. food preparation, handling own medication, etc.) The summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.

    Measured: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)

  3. Changes from baseline in self-reported well-being using the World Health Organization-5 Well-Being Index (WHO-5)

    This questionnaire for general mental well-being consists of five (5) statements and will ask participants to rate how often they have agreed with each statement in the past two weeks. The raw score ranges from 0 (worst possible quality of life) to 25 (best possible quality of life).

    Measured: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)

  4. Changes from baseline in visual attention and speed using Re:ViewD

    This vision test will be completed within the VR headset and will measure visual processing speed, sustained visual attention, and divided visual attention. This is a VR version of the Useful Field of View (UFoV) test which has been extensively used to measure visual attention in healthy individuals and older adults with low vision.

    Measured: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)

  5. Changes from baseline in visual cognition using Re:ShapeD

    This vision test will be completed within the VR headset and will measure visual cognition. This is a VR version of the Motor-Free Visual Perception Test (MVPT) which evaluates visual perception, in particular discrimination, figure-ground, visual memory, spatial relationships, and visual closure.

    Measured: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)

  6. Virtual-Reality Induced Symptoms and Effects (VRISE) - initial screening

    This questionnaire is made up of five (5) questions related to possible cybersickness symptoms and will be completed within the VR headset by using the hand controller. Participants will complete the VRISE immediately after being trained to use Re:Garde at the initial visit. The VRISE score ranges from 5 (very intense level of symptoms and effects) to 35 (very low level of symptom and effects).

    Measured: Initial Visit (Day 1)

  7. Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period

    This questionnaire is made up of five (5) questions related to possible cybersickness symptoms and will be completed within the VR headset by using the hand controller. Participants will complete the VRISE immediately before and after each VR training session. The VRISE score ranges from 5 (very intense level of symptoms and effects) to 35 (very low level of symptom and effects).

    Measured: Every other day with training session (Weeks 1-6)

Timeline

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

  1. First posted16 Nov 2022
  2. Study start26 Oct 2023
  3. Primary completion27 Jun 2024
  4. Study completion27 Jun 2024

Why it stopped: Insufficient enrollment

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619432
Sponsor's protocol ID
22-5847
Acronym
Re:Garde
Status last verified
Jan 2025
First submitted
8 Nov 2022
Last updated
10 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008 Apr;108(4):52-62; quiz 62-3. doi: 10.1097/01.NAJ.0000314810.46029.74.

    PubMed 18367931

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PubMed 25831962

  • Mangione CM, Phillips RS, Seddon JM, Lawrence MG, Cook EF, Dailey R, Goldman L. Development of the 'Activities of Daily Vision Scale'. A measure of visual functional status. Med Care. 1992 Dec;30(12):1111-26. doi: 10.1097/00005650-199212000-00004.

    PubMed 1453816

  • Saredakis D, Szpak A, Birckhead B, Keage HAD, Rizzo A, Loetscher T. Factors Associated With Virtual Reality Sickness in Head-Mounted Displays: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2020 Mar 31;14:96. doi: 10.3389/fnhum.2020.00096. eCollection 2020.

    PubMed 32300295

  • Wittinghofer A, Warren WF, Leberman R. Structural requirements of the GDP binding site of elongation factor Tu. FEBS Lett. 1977 Mar 15;75(1):241-3. doi: 10.1016/0014-5793(77)80095-1. No abstract available.

    PubMed 323049

  • Leat SJ, Lovie-Kitchin J. Visual impairment and the useful field of vision. Ophthalmic Physiol Opt. 2006 Jul;26(4):392-403. doi: 10.1111/j.1475-1313.2006.00383.x.

    PubMed 16792739

  • Richards E, Bennett PJ, Sekuler AB. Age related differences in learning with the useful field of view. Vision Res. 2006 Nov;46(25):4217-31. doi: 10.1016/j.visres.2006.08.011. Epub 2006 Oct 5.

    PubMed 17027061

  • Brown T, Elliott S. Factor structure of the Motor-Free Visual Perception Test-3rd edition (MVPT-3). Can J Occup Ther. 2011 Feb;78(1):26-36. doi: 10.2182/cjot.2011.78.1.4.

    PubMed 21395195

Questions about this trial

What is this clinical trial studying?

A study testing HMD: Immersive VR in people with Vision, Low and Visual Impairment, run by University Health Network, Toronto at 2 sites 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.

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?

Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS) (time frame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)). The study lists 7 primary outcomes in all. 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 NCT05619432, which also lists 8 linked publications.

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 10 Jan 2025.

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