Virtual Reality Clinical Trial
Official title:
Effects of the Fully Immersive Virtual Reality Cognitive Training Based on Leisure Activities for the Elderly With Mild Cognitive Impairment and Subjective Cognitive Decline.
NCT number | NCT04779671 |
Other study ID # | 202002283B0 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2021 |
Est. completion date | July 2024 |
Mild cognitive impairment (MCI) and subjective cognitive decline (SCD) are risk groups for dementia, and thus appropriate interventions are required. Cognitive training is a common intervention applied to the elderly with cognitive decline. Cognitive training integrated into leisure activities can increase the training motivation of the elderly, while improving cognitive performance and daily functions. Virtual reality (VR) can simulate daily living situations, and it can be an effective intervention with cognitive training. Although a few studies have found immersive VR cognitive training can improve the cognitive function of the elderly with cognitive decline, these studies have shown inconsistent results. In addition, it is yet not clear the long-term effect of fully immersive VR cognitive training and its impact on daily function. Furthermore, for immersive VR cognitive training, there is still a lack of training programs that integrate into the context of leisure activities. This type of VR cognitive training could help the effectiveness of cognitive training to be transferred into daily functions.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | MCI Inclusion Criteria: - age range from 60 to 90 years - self- or informant-reported memory or cognitive complaint. - able to follow instruction - MMSE score <26 - dose not have dementia. SCD Inclusion Criteria: - age range from 60 to 90 years; - MMSE>=26; - ECog-12 score >1; - does not conform the standards of MCI and dementia . Exclusion Criteria: - dizziness or epilepsy history; - neurological or other orthopedic diseases with neurological or other orthopedic diseases unstable physical condition of VR cognitive training; - Recent psychiatric diagnosis, such as depression. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung University | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change scores of the Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. | baseline, posttest (around 12 weeks after baseline) | |
Primary | Change scores of the Wechsler Memory Scale - Third Edition (WMS-III) | Several subtests of Wechsler Memory Scale - Third Edition (WMS-III) including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), and Spatial Span (total scale=32) will be used to assess the immediate, delayed, and working memory tests. For each subtest, a higher number indicates better performance in memory function. The raw score of subtests will also be transferred to standardized Z scores and summed to represent an index of general memory function. | baseline, posttest (around 12 weeks after baseline) | |
Primary | Change scores of Stroop Color-Word Test | The Stroop Color-Word test assesses the abilities of selective attention, inhibition and executive function. 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. In both conditions, the number of colors correctly named within 45 seconds will be measured and the performance in the congruent condition will be compared with the incongruent condition. | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of the Wechsler Adult Intelligence Scale (WAIS) | The dual-task tests will be assessed to determine the ability for an individual to perform 2 tasks simultaneously. The investigators will assess the dual-task performance during walking and performing box and block test. The results of the dual-task tests will provide information regarding to whether the 2 tasks compete for the same class of neural resources or one of the tasks can be carried out automatically | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of the Everyday Cognition scales (ECog)-12 items | To detect cognitive and functional decline. The ECog shows promise as a useful tool for the measurement of general and domain-specific everyday functions in the elderly. There are six domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) in ECog. Lower scores represent a higher level of function in daily life. | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL) | Assess activities of daily living. There are 8 domains of function measured with the Lawton IADL scale, including ability to use phone,shopping, food preparation, housekeeping, laundering, mode of transportation, responsibility for own medications,and ability to handle finances. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent). For each category, circle the item description that most closely resembles the client's highest functional level (either 0 or 1). | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of the WHOQOL-BREF Taiwan Version | Exploratory and confirmatory factor analyses revealed a four-factor (physical, psychological, social, and environmental) model. The internal consistency (Cronbach's a) coefficients ranged from 0.70 to 0.77 for the four domains. The test-retest reliability coefficients with intervals of 2 to 4 weeks ranged from 0.41 to 0.79 at item/facet level and 0.76 to 0.80 at domain level (all p < 0.01). Content validity coefficients were in the range of 0.53 to 0.78 for item-domain correlations and 0.51 to 0.64 for inter-domain correlations (all p < 0.01). The four domains of the brief form can explain 88% of the variance of the total QOL score and 60% of the variance of the Facet G score (measuring overall quality of life and general health). | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of Geriatric Depression Scale (GDS) | The Geriatric Depression Scale (GDS) - 15 items version is a self-administered questionnaire used to evaluate mood and depressive symptoms. The scores range is 0-15 and a score of 5 or greater taken as a possible indicator of depression. | baseline, posttest (around 12 weeks after baseline) | |
Secondary | Change scores of The Chinese Aging Well Profile (CAWP) | The 31-item Chinese Aging Well Profile comprised seven subscales-'physical', 'psychological', 'independence', 'learning & growth', 'material', 'environmental', and 'social' well-being. | baseline, posttest (around 12 weeks after baseline) |
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