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

University Health Network, Toronto

Status: Terminated

Conditions: Visual Impairment; Vision, Low

Treatments: Device: HMD: Immersive VR

Study type: Interventional

Funder types: Other

Identifiers

NCT05619432

22-5847

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group A: Clinic Setting

Experimental group

Description:

Participants 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.

Treatment:

Device: HMD: Immersive VR

Group B: Home Setting

Experimental group

Description:

Participants 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.

Treatment:

Device: HMD: Immersive VR