The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia
NCT07033468, Not applicable, Recruiting, Chang Gung Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia | ClinicalTrials.gov |
| NCT number | NCT07033468 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chang Gung Memorial Hospital | ClinicalTrials.gov |
| Conditions | Mild to Moderate Dementia | ClinicalTrials.gov |
| Interventions | VR-WLC, CTL-VR | ClinicalTrials.gov |
| First posted | 2025-06-24 | ClinicalTrials.gov |
| Last updated | 2026-08-26 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change scores of Montreal Cognitive Assessment | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases. | ClinicalTrials.gov |
| Primary | Change scores of Stroop test | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition.Minimum: 0 , Maximum: but typically no upper limit. Higher scores indicate worse performance (greater cognitive interference and slower response time). | ClinicalTrials.gov |
| Primary | Change scores of Color trials test | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.Minimum: Greater than 1 second (best performance) Maximum: No upper limit .Higher scores indicate worse performance (longer completion time and greater cognitive impairment). | ClinicalTrials.gov |
| Primary | Change scores of Frontal Assessment Battery | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | This study utilizes this scale to assess various aspects of frontal lobe function, including executive function, behavioral regulation, and planning. The test consists of six subtests: Similarities, Verbal Fluency, Motor Sequencing, Conflicting Instructions, Go-No-Go, and Comprehending Behavior. Each subtest is scored from 0 to 3, with a total possible score of 18 points. The Taiwanese version of the frontal assessment scale has demonstrated good reliability and validity, showing consistency with tconsistency with the original version and strong construct validity. Minimum: 0 (worst performance) Maximum: 18 (best performance) Higher scores indicate better frontal lobe function, while lower scores suggest greater impairment. | ClinicalTrials.gov |
| Secondary | Change scores of Barthel Index | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | It is a commonly used assessment scale for evaluating activities of daily living (ADL), primarily designed to measure the effectiveness of treatment and the degree of functional decline in patients. The Barthel Index consists of 10 assessment items, each assigned a corresponding score (0, 5, or 10 points), with a maximum total score of 100 points. A lower total score indicates greater dependence on others and a reduced ability to perreduced ability to perform daily self-care activities. | ClinicalTrials.gov |
| Secondary | Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | The Amsterdam Instrumental Activity of Daily Living (A-IADL) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. Each item has a 5-point scale response option (scored 0-4). The scoring of the Amsterdam Instrumental Activity of Daily Living is calculated using item response theory .Lower scores indicating poorer performance. Higher scores indicate better performance in instrumental activities of daily living, while lower scores suggest greater impairment. | ClinicalTrials.gov |
| Secondary | Change scores of The Chinese Dementia-Quality of Life instrument, DQoL | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | This study utilizes the Chinese version of the Quality of Life in Dementia (QOL-D) assessment tool to evaluate the physical and mental health of individuals with dementia and to understand the impact of VR cognitive training on their well-being. The questionnaire comprises five dimensions: positive emotions, negative emotions, sense of belonging, self-esteem, and aesthetics, with a total of 29 items. Each item is rated on a scale from 0 to 5, indicating varying levels of quality. This questionnaire is applicable to individuals with mild to moderate dementia, and its Chinese version has been validated among dementia patients in Taiwan. Minimum: 0 (worst quality of life) Maximum: 145 (best quality of life, calculated as 29 items × maximum score of 5 per item). Higher scores indicate better quality of life, while lower scores suggest poorer well-being. | ClinicalTrials.gov |
| Secondary | Change scores of The Cornell Scale for Depression in Dementia Chinese version | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | This study utilizes the Chinese version of the Cornell Scale for Depression in Dementia (CSDD) to assess depressive symptoms in individuals with dementia before and after the intervention, aiming to understand the impact of the intervention on their quality of life. The scale covers five dimensions: mood-related signs, behavioral disturbances, physical signs, cyclic functions, and ideational disturbances, with a total of 19 items. Each item is scored based on severity, ranging from 0 (no symptoms) to 2 (severe symptoms). A total score above 10 suggests a possible diagnosis of depression, while a score below 6 indicates that depression can be ruled out. The Chinese version has established reliability and validity, demonstrating good psychometric properties. Minimum: 0 (no depressive symptoms) Maximum: 38 (severe depressive symptoms, calculated as 19 items × maximum score of 2 per item) Higher scores indicate more severe depressive symptoms, while lower scores suggest | ClinicalTrials.gov |
| Secondary | Change scores of Clinical Dementia Rating, CDR | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | This study utilizes the Clinical Dementia Rating (CDR) scale to assess the severity of cognitive decline in individuals with dementia. The evaluation is conducted by professional physicians and clinical psychologists to comprehensively assess the cognitive function of participants. The assessment includes six functional domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. Based on the scoring criteria of the scale, a final score is derived to represent the current severity of dementia. This score serves as an important reference for tracking the progression of the disease over time. The Chinese version of the CDR scale has been validated and has demonstrated good reliability and validity Minimum: 0 (normal cognitive function) Maximum: 3 (severe dementia) Higher scores indicate more severe cognitive impairment. | ClinicalTrials.gov |
| Secondary | Change scores of Behavioral and Psychological Symptoms of Dementia, BPSD | Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment . | We use behavioral and psychological symptoms of dementia (BPSD) to assess the behavioral and psychological aspects of individuals with dementia. Dementia is not only characterized by cognitive impairment but is also frequently accompanied by non-cognitive symptoms such as depression, anxiety, delusions, hallucinations, behavioral disturbances, and other psychiatric symptoms. According to a past study conducted in Taiwan, the prevalence of non-cognitive symptoms among individuals with dementia was as high as 30% (Fuh \& Liu, 2006). BPSD is also the primary source of burden for family caregivers of dementia patients. Additionally, compared to improvements in cognitive function, BPSD is often more noticeably improved in clinical settings. Minimum: 0 Maximum: Depends on the number of items and scoring system of the specific BPSD scale used Higher scores indicate more severe behavioral and psychological symptoms in individuals with dementia, while lower scores suggest fewer or no symptoms | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)