Virtual Reality Training to Support Daily Activities for People Living With Dementia

NCT07829913 | Not Yet Recruiting

• 1 other identifier: 26401
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dementia

Keywords

Virtual Reality; Occupational Therapy; Instrumental Activities of Daily Living; Rehabilitation; Home-Based Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Canadian Occupational Performance Measure (COPM)

  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.

  Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Post-VR Intervention Interview

  Week 4 immediately post-intervention

Study Arms (2)

VR-Based IADL Training

EXPERIMENTAL

Device: At-Home VR-Based IADL Training

Cognitive Stimulation Control

ACTIVE COMPARATOR

Behavioral: Cognitive Stimulation Activities

Interventions

At-Home VR-Based IADL Training DEVICE

The intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment.

VR-Based IADL Training

Cognitive Stimulation Activities BEHAVIORAL

This intervention includes structured word-based cognitive activities (e.g., crossword puzzles, logic games).

Cognitive Stimulation Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18 years or older
• Primary familial or spousal caregiver who provides daily care

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Alzheimer's Association: collaborator

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hee-Tae Jung, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Babb, MS

CONTACT

7655248768; ecbabb@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Health Informatics

Model Details: This is a two-arm, parallel-assignment randomized pilot trial. Eligible participants will be randomized in a 1:1 ratio to either the VR-based IADL training intervention group or the cognitive stimulation control group. Randomization will occur after eligibility is confirmed. An independent statistician who is not involved in recruitment, intervention delivery, or outcome assessment will generate the allocation sequence using variable block sizes. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. An unblinded research assistant who is not involved in outcome assessment will open the next envelope in sequence and implement the assigned condition.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share