Re:Garde Program - Training and Maintaining Visual Perception in Older Adults
NCT ID: NCT05619432
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2023-10-26
2024-06-27
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Group A: Clinic Setting
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.
HMD: Immersive VR
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.)
Group B: Home Setting
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.
HMD: Immersive VR
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.)
Interventions
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HMD: Immersive VR
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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* Cervical conditions, injuries, or open face wounds that would make it unsafe to use the VR headset
* Cannot speak or understand English
65 Years
ALL
Yes
Sponsors
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Perley Rideau
UNKNOWN
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Michael Reber, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Lora Appel, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Perley Health
Ottawa, Ontario, Canada
Krembil Research Institute, UHN
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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22-5847
Identifier Type: -
Identifier Source: org_study_id
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