Virtual Reality Training to Support Daily Activities for People Living With Dementia
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Erica Babb, MS
- Telefonszám: 7655248768
- E-mail: ecbabb@iu.edu
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: VR-Based IADL Training
|
The intervention is designed to provide safe, structured, and repeatable practice of everyday activities in a virtual environment. |
|
Aktív összehasonlító: Cognitive Stimulation Control
|
This intervention includes structured word-based cognitive activities (e.g., crossword puzzles, logic games). |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Canadian Occupational Performance Measure (COPM)
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Cognitive Performance Test (CPT)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Post-VR Intervention Interview
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Hee-Tae Jung, PhD, Indiana University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 26401
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
az Egyesült Államokban gyártott és onnan exportált termék
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .