Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2021
Source Chang Gung Memorial Hospital
Contact I-Ching Chuang, Ph.D
Phone #886-3-2118800
Email ichin@mail.cgu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This study aims to (1) determine the feasibility and usability of immersive leisure-based VR cognitive training; (2) identify the intervention effects of immersive leisure-based VR cognitive training on cognitive function, daily function, and quality of life for elderly with MCI and SCD; (3) compare the intervention effects between elderly with MCI and SCD on outcome measures. The investigators will recruit 30 elderly with MCI, 30 elderly with SCD, and 15 specialists for the feasibility and usability study. They will receive one immersive leisure-based VR cognitive training for 30 minutes. VR cognitive training receives four gardening activities. The cognitive elements including attention, working memory, processing speed, and executive function incorporated training. The investigators will use the Acceptance of the Virtual Reality (VR) Experience Questionnaire and System Usability Scales. For effectiveness study, the investigators will recruit 60 elderly with MCI and 70 elderly with SCD. Participants will be randomly assigned to VR group and control group. All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. The content of VR training is the same as before. The control group is performing traditional cognitive training program. The primary cognitive outcome measurements will include the Montreal Cognitive Assessment, Wechsler Memory Scale, Stroop test, and color trials test. Other outcomes will include measurements that evaluate the cognitive, daily functions, and quality of life of elderly with MCI and SCD. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance (ANOVA) will be used to evaluate the changes in outcome measures at three different time points. The investigators anticipate the VR training can facilitate cognitive function, daily function, and quality of life. The significance of this study is identifying the effect of immersive VR cognitive training based on leisure activities, and it is appropriate to provide this training for elderly with MCI and SCD. It could delay and prevent the progression to dementia and lead the field of technological assistance to new opportunities for training.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
VR cognitive training
All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. They will receive one immersive leisure-based VR cognitive training for 30 minutes. VR cognitive training receives four gardening activities. The cognitive elements including attention, working memory, processing speed, and executive function incorporated training.
Traditional cognitive training
All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions. The control group is performing traditional cognitive training program.

Locations

Country Name City State
Taiwan Chang Gung University Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Recruiting NCT05528497 - Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Completed NCT04091659 - Use of Virtual Reality for Overdose Management Educational Trainings N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Not yet recruiting NCT05982457 - The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching N/A
Completed NCT06112600 - The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination N/A
Active, not recruiting NCT04532866 - Brain Changes in Response to Long-Duration Isolation and Confinement N/A
Completed NCT05604924 - Virtual Reality Training Simulator for Cesarean Section N/A
Recruiting NCT04736888 - Effectiveness of Extended Reality CPR Training Methods N/A
Not yet recruiting NCT05941390 - Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures N/A
Completed NCT05961033 - The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Recruiting NCT04630184 - A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity N/A
Terminated NCT03665233 - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty N/A
Recruiting NCT03698526 - Virtual Reality for Symptoms Control in Palliative Care N/A
Suspended NCT03715400 - Mobile Virtual Positive Experiences for Anhedonia N/A
Completed NCT03208400 - Virtual Reality Exposure in Spider Phobia N/A
Completed NCT05078762 - Immersive Virtual Reality in Simulation-based Bronchoscopy Training N/A