Investigating the Impact of VR-Assisted Training on Daily Activity Performance Among People Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change in Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
This study will test whether a home-based virtual reality training program can help people living with dementia practice everyday activities. Many people with dementia experience difficulty completing instrumental activities of daily living, such as preparing food, washing dishes, managing money, or completing household tasks. Virtual reality may provide a safe and engaging way to practice these activities in a realistic environment.
Participants will be randomly assigned to one of two groups. One group will use a virtual reality training program focused on everyday activities, and the other group will complete cognitive stimulation activities, such as word puzzles. The study will last four weeks, with 30-minute sessions completed at home five times per week. Participants will complete assessments at the beginning of the study, after the four-week program, and again four weeks later.
The study team hypothesizes that people who use the virtual reality training program may show greater improvements in everyday activity performance, engagement, and quality of life compared with people who complete traditional cognitive stimulation activities.
详细描述
This study is a single-blind, two-arm randomized pilot trial designed to evaluate the preliminary therapeutic impact of a customizable, home-based virtual reality (VR) training system for people living with dementia. The intervention is intended to support engagement and performance in instrumental activities of daily living (IADLs), such as preparing food, washing dishes, managing money, or completing household tasks.
Participants will be randomized in a 1:1 ratio to either the intervention group or the control group. Participants assigned to the intervention group will complete IADL-based VR training. The VR system includes simulated home environments, such as a kitchen, where participants can practice IADLs such as retrieving ingredients for cooking and washing dishes. The system is designed to provide safe, structured, and repeatable practice of functional tasks that may otherwise be difficult to practice in real-world settings because of safety or logistical concerns.
Participants assigned to the control group will complete cognitive stimulation activities, such as word puzzles. This comparison condition reflects a traditional non-pharmacological approach that is commonly used to support cognitive engagement among people living with dementia.
The intervention period will last four weeks. Participants will complete 30-minute home-based sessions five times per week. Outcomes will be assessed at baseline, immediately after the four-week intervention period, and at a follow-up visit four weeks after the intervention ends. These assessments will examine changes in IADL performance, cognitive-functional ability, cognitive status, and quality of life.
In addition to standardized assessments, participants in the VR group and their caregivers will complete a brief exit interview after the intervention period. These interviews will gather feedback on usability, task realism, emotional responses, perceived benefits, and barriers or facilitators to using the VR system at home. Qualitative findings will be used to guide future refinements to the VR program and improve its accessibility, usability, and relevance for people living with dementia and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will remain blinded to group assignment throughout data collection and data entry. Participants will be instructed not to disclose their assigned group to the outcome assessor. The blinded assessor will not be involved in intervention delivery, adherence check-ins, activity adjustments, or other procedures that could reveal group assignment. An unblinded research assistant who is not involved in outcome assessment will implement the assigned intervention and conduct weekly adherence check-ins. Data analysts will receive de-identified datasets labeled only with group codes to help preserve masking during statistical comparisons.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Alzheimer's disease or a dementia-related condition that shares similar or overlapping symptoms with Alzheimer's disease, confirmed by a licensed healthcare provider (e.g., neurologist, geriatrician, or primary care physician); for caregiver-reported diagnoses, supporting documentation must be obtained prior to enrollment.
- •MMSE score between 20 to 25 (mild dementia)
- •Capacity to consent
- •Ability to engage meaningfully in at least one IADL task relevant to the intervention, ensuring capacity to interact with the functional tasks targeted within the VR system.
- •Safe, quiet home environment appropriate for VR, with access to an indoor space suitable for engaging in study activities:
- •At least 3 × 3 feet of unobstructed floor space. Adequate lighting to clearly view the device and physical surroundings. Stable chair without wheels for VR use.
- •Willingness and ability to follow the study protocol, including completion of 30-minute intervention sessions five times per week for four weeks and participation in assessment sessions at baseline (Week 0), post-intervention (Week 4), and follow-up (Week 8).
- •English language proficiency sufficient to complete the intervention and assessments, including interviews, cognitive testing, and interactive VR tasks.
- •Participants must have access to a smartphone, owned by the participant or their caregiver, and be willing to use it to host the VR application.
- •Caregivers' inclusion criteria include:
- •Age 18 years or older
- •Primary familial or spousal caregiver who provides daily care
排除标准
- •Impaired reasoning/judgment that affects daily life
- •Severe visual, hearing, or motor impairments that would limit the participant's ability to use VR safely or engage with the system's content.
- •Significant psychiatric or neurological conditions (e.g., active psychosis, uncontrolled depression, recent seizures) that may interfere with participation or safety.
- •Medical conditions that pose safety risks, including those that could be aggravated by visual immersion (e.g., uncontrolled vertigo, history of VR-induced motion sickness).
- •Significant acute or chronic medical, neurological, or other illnesses that, in the judgment of the principal investigator (PI), could compromise participant safety, hinder study completion, or interfere with study objectives.
- •Concurrent participation in other interventional studies, particularly those involving cognitive rehabilitation or VR, that may confound study results.
- •MMSE score below 20, indicating cognitive impairments more advanced than mild dementia.
研究组 & 干预措施
VR-Based IADL Training
干预措施: At-Home VR-Based IADL Training (Device)
Cognitive Stimulation Control
干预措施: Cognitive Stimulation Activities (Behavioral)
结局指标
主要结局
Change in Canadian Occupational Performance Measure (COPM)
时间窗: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
The COPM will be used to measure self-perceived performance and satisfaction with meaningful IADLs. People living with dementia, or caregivers when needed, identify important activities and rate performance and satisfaction on a 1-10 scale. A change of 2 or more points in performance is considered clinically meaningful.
次要结局
- Change in Cognitive Performance Test (CPT)(Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up)
- Change in Kettle Test(Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up)
- Change in Kohlman Evaluation of Living Skills (KELS)(Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up)
- Change in Mini-Mental State Examination (MMSE)(Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up)
- Change in Quality of Life in Alzheimer's Disease (QoL-AD)(Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up)
研究者
Hee-Tae Jung
Assistant Professor of Health Informatics
Indiana University