VRision Program - Scaling of a Validated Virtual Reality Training Program for Improving Vision in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes from baseline in self-reported vision based on the Activities of Daily Vision Scale (ADVS)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点