Effects of the Fully Immersive Leisure-based Virtual Reality Cognitive Training for Community-dwelling Elderly

NCT05227495 | Unknown

• 1 other identifier: 202100553B0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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 community-dwelling elderly

Conditions

Community-dwelling Elderly; Virtual Reality

Outcome Measures

Primary Outcomes (4)

• 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, after the intervention eight weeks, and at 3-month follow-up.

• Change scores of Wechsler Memory Scale (WMS)

  Including Faces Recognition (total scale=48), Verbal Paired Associates (total scale = 32), Word Lists (total scale = 48), Memory Span (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, after the intervention eight weeks, and at 3-month follow-up.

• 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

  baseline, after the intervention eight weeks, and at 3-month follow-up.

• 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.

  baseline, after the intervention eight weeks, and at 3-month follow-up.

Secondary Outcomes (14)

• Change scores of Wechsler Adult Intelligence Scale; WAIS

  baseline, after the intervention eight weeks, and at 3-month follow-up.

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

  baseline, after the intervention eight weeks, and at 3-month follow-up.

• Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL

  baseline, after the intervention eight weeks, and at 3-month follow-up.

• Change scores of the World Health Organization Quality of Life-Old(WHOQOL-OLD) Taiwan Version

  baseline, after the intervention eight weeks, and at 3-month follow-up.

• Change scores of Community Integration Questionnaire, CIQ

  baseline, after the intervention eight weeks, and at 3-month follow-up.

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 40 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+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>=60
• able to follow instruction
• MMSE\>=21

You may not qualify if:

• dizziness or epilepsy history;
• neurological or other orthopedic diseases with neurological or other orthopedic diseases (3)unstable physical condition of VR cognitive training;
• (4)Recent psychiatric diagnosis, such as depression

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan District, Taiwan

RECRUITING

Central Study Contacts

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: January 23, 2022
• First Posted: February 7, 2022
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-01

Locations

TW (1)