Virtual Reality Cognitive Training for Older Adults With Mild Cognitive Impairment

NCT06392412 | Not Yet Recruiting

• 1 other identifier: DaYehU
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to (1) develop and assess the feasibility of a fi-VRCT program based on IADL for older adults with MCI, (2) implement and evaluate the effectiveness of the fi-VRCT program based on IADL in older adults with MCI, and (3) investigate the potential mechanism of the fi-VRCT program based on IADL for older adults with MCI and refine this intervention accordingly.

Conditions

Mild Cognitive Impairment; Older Adults

Outcome Measures

Primary Outcomes (4)

• Changes scores of Montreal Cognitive Assessment (MoCA)

  The MoCA comprises12 items, it assesses orientation to time and place, attention, concentration, short-term memory, \\working memory, visuospatial abilities, language, and executive function. Scores on the MoCA range from 0 to 30, with a higher score indicative of better global cognition. A total score of 26 or above is considered within the normal cognitive function range, while a total score of 18 to 25 indicates mild cognitive impairment

  At baseline, at week 9, and at 3-month follow-up.

• Change scores of Wechsler Memory Scale (WMS)

  The Wechsler Memory Scale is a neuropsychological test designed to assess memory in adults aged 16 to 90. Family Pictures, Spatial Span, and Word List will be used to evaluate visual, auditory, immediate, delayed, and working memory. For each subtest, higher scores indicate better performance in memory performance. Based on age ranges, raw scores will be transformed into scaled scores ranging from 1 to 19.

  At baseline, at week 9, and at 3-month follow-up.

• Change scores of Amsterdam Instrumental Activities of Daily Living Questionnaire, Short Version

  The questionnaire is informant-reported and is typically completed by a caregiver. It comprises 30 items in seven categories: household activities, household appliances, finances, work, computer use, appliances, and leisure activities. Each item is rated based on the difficulty levels in performing it, ranging from no difficulty in performing the task to no longer being able to perform it. Score ranges from 0 to 100 and lower score indicates better functional ability.

  At baseline, at week 9, and at 3-month follow-up.

• Change scores of Lawton Instrumental Activities of Daily Living

  The Lawton Instrumental Activities of Daily Living is commonly employed to assess participants' ability to perform daily tasks and identify early functional decline. In semi-structured interviews, participants describe how they currently perform the eight IADLs. Each item is rated based on the levels of competence, ranging from independence in performing the activity to not being able to perform it at all. Score ranges from 8 to 31 and higher scores indicate better functional ability.

  At baseline, at week 9, and at 3-month follow-up.

Secondary Outcomes (2)

• Change scores of Digit Span

  At baseline, at week 9, and at 3-month follow-up.

• Change scores of Stroop Color-Word Test

  At baseline, at week 9, and at 3-month follow-up.

Other Outcomes (4)

• Presence Questionnaire

  The initial, second, fifth, ninth, thirteenth, and final intervention sessions.

• Immersive Tendencies Questionnaire

  The initial, second, fifth, ninth, thirteenth, and final intervention sessions.

• Simulator Sickness Questionnaire

  The initial, second, fifth, ninth, thirteenth, and final intervention sessions.

Study Arms (2)

VR Group

EXPERIMENTAL

Behavioral: fi-VR Cognitive Training

Control Group

ACTIVE COMPARATOR

Behavioral: Traditional Cognitive Training

Interventions

fi-VR Cognitive Training BEHAVIORAL

All participants will 16 sessions over eight weeks, with two sessions per week, each lasting 70 minutes. Participants in the fi-VRCT will use the virtual reality system with head-mounted display and handheld controllers. The fi-VRCT will be administered by an experienced research assistant.

VR Group

Traditional Cognitive Training BEHAVIORAL

All participants will 16 sessions over eight weeks, with two sessions per week, each lasting 70 minutes. The CT control program will include cognitive board games designed to improve various cognitive capacities. Certified community occupational therapists will lead the CT control group.

Control Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 or above.
• MoCA score between 18 and 25.
• Capability to follow directions and do tasks.

You may not qualify if:

• History of dementia.
• Previous neurodegenerative illness diagnosis.
• Severe medical or surgical problems.
• Major psychological disorders.
• Inability to use VR system

Sponsors & Collaborators

• Da-Yeh University: lead

Related Publications (1)

• Chen IC, Wu CY, Hu YL, Huang YM. Development and Validation of Virtual Reality Cognitive Training for Older Adults with Mild Cognitive Impairment: Protocol for a Mixed-Methods Program Evaluation Study. Clin Interv Aging. 2024 Nov 9;19:1855-1865. doi: 10.2147/CIA.S471547. eCollection 2024.

  PMID: 39539569 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07