Clinical trial · Interventional
Improving Everyday Task Performance Through Repeated Practice in Virtual Reality.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There are very few effective interventions that promote functional independence in people with Alzheimer's disease (AD) and related dementias. This R21 project is the first step in the long-term goal of developing an effective, enjoyable, portable, and inexpensive non-immersive virtual reality (VR) training intervention for improving the performance of everyday tasks. The investigators' VR training approach is built upon the results of past studies that show 1) when people with AD repeatedly practice daily tasks they subsequently perform them more completely and without error; and 2) healthy people are able to transfer skills learned in VR-contexts to tasks in the real world. This R21 study will obtain preliminary data to inform a future randomized clinical trial through three aims: Aim 1) To test the hypothesis that individuals with mild-moderate AD will show improved performance on an everyday task after repeatedly practicing the task in a non-immersive VR setting; Aim 2) To explore usability and acceptability of the VR training as well as associations between individual differences variables (e.g., cognitive abilities, demographics) and training effects. To test Aim 1, 40 participants with mild to moderate AD will be recruited to complete daily VR Training sessions for one week. VR Training will include repeated practice of a single, everyday task in a non-immersive VR-context (VR Breakfast or VR Lunch; counterbalanced across participants). The primary outcome measure is performance of the real-life version of the trained task, which will be collected before and at two time points after training, compared to performance of an untrained, control task of comparable difficulty, and scored from video by coders blinded to training task/condition. To evaluate Aim 2, all participants and an informant will complete interviews and questionnaires and participants will complete tests of cognitive abilities. Usability and acceptability of the VR training will be evaluated and associations between participant variables and VR Training results will be explored. If the proposed hypothesis is supported and results show that training effects generalize from virtual to real tasks in the study sample, then VR training of custom and individualized tasks will be investigated in a future randomized, controlled clinical trial for maintaining and improving functional abilities in people with mild to moderate AD.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Dementia Alzheimers | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia, Mixed | — | UNRESOLVED | — |
| Dementia of Alzheimer Type | — | UNRESOLVED | — |
| Dementia, Vascular | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
| Mild Dementia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virtual Kitchen Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Training Arm
- description
- This is a within-participant study with two arms. All participants receive the Virtual Training with one target task and they are tested (after one day and one month) on the target task (arm 1) and as well as on a control task(arm 2). Assignment to the specific task that is trained is randomized across participants.
- interventionNames
- Behavioral: Virtual Kitchen Training
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- This is a within-participant study with two arms. All participants receive the Virtual Training with one target task and they are tested (after one day and one month) on the target task (arm 1) and as well as on a control task(arm 2). Assignment to the specific task that is trained is randomized across participants.
Primary outcomes (8)
- measure
- Real Trained Task Performance- Accomplishment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion/Exclusion Criteria: 1. 65 years or older; 2. fluency in the English language; 3. availability of an informant reporter who has knowledge of the participant's daily functioning; 4. no lifetime history of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma) other than Alzheimer's disease; 5. no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer); 6. no current major depression or moderate-severe depression symptoms; 7. no current moderate - severe, uncontrolled anxiety symptoms; 8. no severe sensory deficits that would preclude visual detection or identification of common everyday objects used in the study or the inability to hear the task directions (e.g., blindness, total hearing loss); 9. no severe motor weakness that would preclude the use of everyday objects or the VR Training computer touch screen (e.g., severe deformities or paralysis of both upper extremities) ; 10. intact estimated general intellectual functioning (i.e., no history of intellectual disability); 11. available to participate in the one-month follow-up session after the VR Training (i.e., no surgery, travel, etc. scheduled over the next month); 12. diagnosis of mild to moderate Alzheimer's disease within the past year, including confirmation of mild to moderate dementia on Mini Mental Status Exam (score approximately 25 or lower), significant functional difficulties reported by informant report, and cognitive impairment on demographically adjusted (age, education, sex, and race) cognitive test scores at baseline. An informant (N = 40) also will be recruited for each participant with dementia. Informants are people who know the participant well and interact with the participant on a daily basis. Informants will be asked to report on the participants' daily functioning and the extent to which the informant is burdened by the participants. Informants also will be asked to report on changes in medical or mental status during the study period. Informant eligibility criteria is listed below: 1. 18 years of age or older 2. fluency in the English language 3. available and willing to complete study questionnaires in person or by phone 4. has daily contact with the participant 5. reports that he/she is knowledgeable of the participant's daily functioning
References
Publications (0)
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