Effects of the Fully Immersive VR Cognitive Training Based on Leisure Activities for the Elderly With MCI and SCD.

NCT04779671 | Unknown

• 1 other identifier: 202002283B0
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

MCI; SCD; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (6)

• Change scores of the Wechsler Adult Intelligence Scale (WAIS)

  baseline, posttest (around 12 weeks after baseline)

• Change scores of the Everyday Cognition scales (ECog)-12 items

  baseline, posttest (around 12 weeks after baseline)

• Change scores of the Lawton Instrumental Activities of Daily Living Scale (IADL)

  baseline, posttest (around 12 weeks after baseline)

• Change scores of the WHOQOL-BREF Taiwan Version

  baseline, posttest (around 12 weeks after baseline)

• Change scores of Geriatric Depression Scale (GDS)

  baseline, posttest (around 12 weeks after baseline)

Study Arms (2)

VR group

EXPERIMENTAL

Behavioral: VR cognitive training

control group

ACTIVE COMPARATOR

Behavioral: Traditional cognitive training

Interventions

VR cognitive training BEHAVIORAL

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.

VR group

Traditional cognitive training 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.

control group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• age range from 60 to 90 years;
• MMSE\>=26;
• ECog-12 score \>1;
• does not conform the standards of MCI and dementia .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

Study Officials

• I-Ching Chuan, Ph.D

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Ching Chuang, Ph.D

CONTACT

#886-3-2118800; ichin@mail.cgu.edu.tw

Ching-yi Wu, ScD

CONTACT

#886-3-2118800; cywu@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 3, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

TW (1)