Effects and Mechanism of the Fully Immersive Virtual Reality Cognitive Training Based on Leisure Activities

NCT ID: NCT05682469

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-07-31

Brief Summary

The aim of this study is to identify the effects of the immersive leisure-based VR cognitive training, and compare the intervention effects for elderly with MCI and SCD. The investigators anticipate the VR training can facilitate cognitive function, daily function, quality of life. The investigators anticipated the metabolic biomarkers, mechanism, and brain activities will be found. The significance of this study is identifying the effect of immersive leisure-based VR cognitive training, and confirming the metabolic biomarkers and brain activities. It could improve the accuracy of identification, prevent the progression to dementia, and lead the field of technological assistance to new opportunities for training.

Conditions

MCI; SCD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR group

VR cognitive training receives eight gardening activities. The cognitive elements including attention, working memory, processing speed, and executive function incorporated training.

Group Type: EXPERIMENTAL

VR cognitive training

Intervention Type: BEHAVIORAL

All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.

All participants will receive one immersive leisure-based VR cognitive training for 40 minutes. VR cognitive training receives four gardening activities.

The cognitive elements including attention, working memory, processing speed, and executive function incorporated training.

control group

The control group is performing traditional cognitive training program.

Group Type: ACTIVE_COMPARATOR

Traditional cognitive training

Intervention Type: BEHAVIORAL

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.

Interventions

VR cognitive training

All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.

All participants will receive one immersive leisure-based VR cognitive training for 40 minutes. VR cognitive training receives four gardening activities.

The cognitive elements including attention, working memory, processing speed, and executive function incorporated training.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

age>=60 able to follow instruction MoCA<26 Scores on cognitive tests for individuals with MCI are 1 to 1.5 standard deviations below the mean for their age and education matched peers on culturally

age>=60 ECog-12 score >1 MoCA>=26; 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ching-Yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

+886-3-2118800 ext. 5761

Other Identifiers

202102478B0

Identifier Type: -

Identifier Source: org_study_id