DementiaNCT07829913
Virtual Reality Training to Support Daily Activities for People Living With Dementia
A study testing At-Home VR-Based IADL Training and Cognitive Stimulation Activities in people with Dementia, run by Indiana University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- At-Home VR-Based IADL Training and Cognitive Stimulation Activities
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- At-Home VR-Based IADL Training, Cognitive Stimulation Activities
- Keywords
- Virtual Reality, Occupational Therapy, Instrumental Activities of Daily Living, Rehabilitation, Home-Based Intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-Home VR-Based IADL TrainingDevice
The intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment.
Cognitive Stimulation ActivitiesBehavioural
This intervention includes structured word-based cognitive activities (e.g., crossword puzzles, logic games).
| Study group | Role | What they receive |
|---|---|---|
| VR-Based IADL Training | Experimental | Not described Receives: Device: At-Home VR-Based IADL Training |
| Cognitive Stimulation Control | Active comparator | Not described Receives: Behavioral: Cognitive Stimulation Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Secondary outcomes (5)
Change in Cognitive Performance Test (CPT)
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Kettle Test
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Kohlman Evaluation of Living Skills (KELS)
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Mini-Mental State Examination (MMSE)
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Change in Quality of Life in Alzheimer's Disease (QoL-AD)
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.
Measured: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Hee-Tae Jung, Indiana University
- Investigators
- Hee-Tae Jung, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829913
- Sponsor's protocol ID
- 26401
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of VR-Assisted Training on Daily Activity Performance Among People Living With Dementia
- ClinicalTrials.gov ID
- NCT07829913
- Acronym / sponsor ID
- 26401
- Conditions
- Dementia
- Keywords
- Virtual Reality, Occupational Therapy, Instrumental Activities of Daily Living, Rehabilitation, Home-Based Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-Based IADL Training | Experimental | Device: At-Home VR-Based IADL Training |
| Cognitive Stimulation Control | Active comparator | Behavioral: Cognitive Stimulation Activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-Home VR-Based IADL TrainingThe intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment. | Device | VR-Based IADL Training |
| Cognitive Stimulation ActivitiesThis intervention includes structured word-based cognitive activities (e.g., crossword puzzles, logic games). | Behavioural | Cognitive Stimulation Control |
Primary outcome
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.
5 secondary outcomes
Change in Cognitive Performance Test (CPT)
Time frame: 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
Change in Kohlman Evaluation of Living Skills (KELS)
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hee-Tae Jung, PhD principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing At-Home VR-Based IADL Training and Cognitive Stimulation Activities in people with Dementia, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Babb, MS (7655248768, ecbabb@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Canadian Occupational Performance Measure (COPM) (time frame: Week 0 Baseline, Week 4 immediately post-intervention, and Week 8 follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.