Sponsor study identifier
interventional
60
1 country
1
Study Start
August 1, 2024
Actual (reported)Primary Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2024
Actual (reported)March 25, 2025
Actual (reported)June 24, 2025
Actual (reported)July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change scores of Montreal Cognitive Assessment
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.
Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Stroop test
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).
Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Color trials test
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).
Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Frontal Assessment Battery
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.
Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
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 .
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 .
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 .
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 .
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 .
Guide the patient through a 5-minute warm-up, which mainly involves explaining, familiarizing with, or reviewing VR operations. After the warm-up, proceed with the first part of the VR gardening training for 10 minutes, followed by 5 minutes of eye and stretching exercises. Then, continue with the second part of the VR gardening training for another 10 minutes, followed by 5 minutes of eye massage and stretching exercises. This sequence is repeated for a total of four cycles.
During the waitlist period, patients will not receive any training but will receive regular phone calls to ensure equal attention.
First, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later.
First, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity.
Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation.
New Taipei City, Taiwan
Ching-yi Wu, ScD
Chang Gung Memorial Hospital
First Submitted
March 25, 2025
First Posted
June 24, 2025
Study Start
August 1, 2024
Actual (reported)Primary Completion
July 31, 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 26, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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