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

NCT05619432 | Terminated

• 1 other identifier: 22-5847
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Vision, Low; Visual Impairment

Outcome Measures

Primary Outcomes (7)

• 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).

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

• 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.

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

• 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).

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

• 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.

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

• 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.

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

• 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).

  Initial Visit (Day 1)

• 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).

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

Study Arms (2)

Group A: Clinic Setting

EXPERIMENTAL

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.

Device: HMD: Immersive VR

Group B: Home Setting

EXPERIMENTAL

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.

Device: HMD: Immersive VR

Interventions

HMD: Immersive VR DEVICE

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 A: Clinic Setting; Group B: Home Setting

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Perley Rideau: collaborator

Study Sites (2)

Perley Health

Ottawa, Ontario, K1G 5Z6, Canada

Location

Krembil Research Institute, UHN

Toronto, Ontario, M5T 0S8, Canada

Location

Related Publications (8)

• 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.

  PMID: 18367931 BACKGROUND

• 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 1453816 BACKGROUND

• 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.

  PMID: 32300295 BACKGROUND

• 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.

  PMID: 323049 BACKGROUND

• 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.

  PMID: 16792739 BACKGROUND

• 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.

  PMID: 17027061 BACKGROUND

• 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.

  PMID: 21395195 BACKGROUND

MeSH Terms

Conditions

Vision, Low; Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Reber, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lora Appel, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 16, 2022
• Study Start: October 26, 2023
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

CA (2)