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

Not Applicable

Terminated

• Conditions: Vision, Low; Visual Impairment

• Registration Number: NCT05619432
• Lead Sponsor: University Health Network, Toronto

Brief 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. 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.

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.

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-16
• Study Start: 2023-10-26
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS)	Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)	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).
Changes from baseline in self-reported well-being using the World Health Organization-5 Well-Being Index (WHO-5)	Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)	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).
Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period	Every other day with training session (Weeks 1-6)	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).
Changes from baseline in visual attention and speed using Re:ViewD	Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)	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.
Changes from baseline in visual cognition using Re:ShapeD	Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)	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.
Virtual-Reality Induced Symptoms and Effects (VRISE) - initial screening	Initial Visit (Day 1)	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).
Changes from baseline in self-reported independence/autonomy using the Instrumental Activities of Daily Living (IADL) Scale	Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)	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.

Trial Locations

Locations (2)

Perley Health; 🇨🇦 Ottawa, Ontario, Canada

Krembil Research Institute, UHN; 🇨🇦 Toronto, Ontario, Canada