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

September 17, 2026 updated by: Hee-Tae Jung, Indiana University

Investigating the Impact of VR-Assisted Training on Daily Activity Performance Among People Living With Dementia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

As a pilot trial, this study is intended to provide preliminary evidence about feasibility, engagement, and potential efficacy. Findings will inform the design of a future fully powered randomized controlled trial evaluating VR-based training for IADLs among people living with dementia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Erica Babb, MS
  • Phone Number: 7655248768
  • Email: ecbabb@iu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VR-Based IADL Training
Device: At-Home VR-Based IADL Training

The intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment.
Active Comparator: Cognitive Stimulation Control
Behavioral: Cognitive Stimulation Activities

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Canadian Occupational Performance Measure (COPM)
Time Frame: 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.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cognitive Performance Test (CPT)
Time Frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

CPT is a performance-based measure of cognitive-functional capacity. In this study, the investigators will use it to examine participants' performance on IADL tasks embedded within the VR environment. This approach reflects their ability to complete complex tasks that demand higher-level cognitive processes such as planning, problem-solving, and working memory.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Kettle Test
Time Frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

The Kettle Test is a brief and ecologically valid assessment of everyday problem-solving and executive function by observing participants' ability to prepare a hot beverage. It involves multiple steps, requiring sequencing, planning, and attention skills that are targeted in the VR training module.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Kohlman Evaluation of Living Skills (KELS)
Time Frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

The KELS measures an individual's ability to perform essential living skills needed to live safely and independently. Specifically, the investigators will conduct the money management subtasks: including using cash to purchase items and paying utility bills.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Mini-Mental State Examination (MMSE)
Time Frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

The MMSE is a widely used brief screening tool for detecting and measuring cognitive impairments. It is comprised of 11 questions that test orientation, registration, attention and calculation, recall, and language.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Quality of Life in Alzheimer's Disease (QoL-AD)
Time Frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

QoL-AD is a validated measure designed to assess quality of life specifically in individuals with Alzheimer's disease. It incorporates both self-report and caregiver perspectives across domains such as physical health, mood, relationships, functional ability, and overall well-being. In this study, QoL-AD will provide insights into how participation in the VR training program influences participants' perceived quality of life, complementing the performance-based and cognitive assessments.
Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-VR Intervention Interview
Time Frame: Week 4 immediately post-intervention

Participants within the VR-Based IADL Training arm and their caregivers will participate in a semi-structured interview. This will explore usability, emotional responses, task realism, and any perceived changes in everyday function. These findings will provide valuable context for interpreting results and will help guide iterative design improvements.
Week 4 immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alzheimer's Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hee-Tae Jung, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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