Clinical trial NCT05619432: Re:Garde Program - Training and Maintaining Visual Perception in Older Adults
Official title: VRision Program - Scaling of a Validated Virtual Reality Training Program for Improving Vision in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vision, Low
Visual Impairment
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Perley Rideau
First posted: 2022-11-16
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS)
timeFrame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)
measure: Changes from baseline in self-reported independence/autonomy using the Instrumental Activities of Daily Living (IADL) Scale
timeFrame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)
measure: Changes from baseline in self-reported well-being using the World Health Organization-5 Well-Being Index (WHO-5)
timeFrame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)
measure: Changes from baseline in visual attention and speed using Re:ViewD
timeFrame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)
measure: Changes from baseline in visual cognition using Re:ShapeD
timeFrame: Initial Visit (Day 1), Mid-point (end of Week 3), Treatment completion (Week 7)
measure: Virtual-Reality Induced Symptoms and Effects (VRISE) - initial screening
timeFrame: Initial Visit (Day 1)
measure: Virtual-Reality Induced Symptoms and Effects (VRISE) - intervention period
timeFrame: Every other day with training session (Weeks 1-6)
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Perley Health
state: Ontario
city: Toronto
country: Canada
facility: Krembil Research Institute, UHN
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Reber, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Lora Appel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.