Virtual Reality Cognitive Training for Older Adults With Mild Cognitive Impairment

July 2, 2024 updated by: I-Chen Chen, Da-Yeh University

Effects of Fully Immersive Virtual Reality Cognitive Training Based on Instrumental Activities of Daily Living for Older Adults With Mild Cognitive Impairment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

As research on cognitive training methods for older adults with mild cognitive impairment (MCI) progresses, fully immersive virtual reality cognitive training (fi-VRCT) has emerged as a promising approach. While the benefits of fi-VRCT for enhancing cognitive function have been recognized, its potential to improve instrumental activities of daily living (IADL) and promote independence remains uncertain. This study addresses these questions by developing and validating a fi-VRCT program based on IADL to enhance cognitive and IADL performance among older adults with MCI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of dementia.
  2. Previous neurodegenerative illness diagnosis.
  3. Severe medical or surgical problems.
  4. Major psychological disorders.
  5. Inability to use VR system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Behavioral: Traditional Cognitive Training
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.
Experimental: VR Group
Behavioral: fi-VR Cognitive Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change scores of Wechsler Memory Scale (WMS)
Time Frame: At baseline, at week 9, and at 3-month follow-up.
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
Time Frame: At baseline, at week 9, and at 3-month follow-up.
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
Time Frame: At baseline, at week 9, and at 3-month follow-up.
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.
Changes scores of Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline, at week 9, and at 3-month follow-up.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change scores of Digit Span
Time Frame: At baseline, at week 9, and at 3-month follow-up.
Participants will be verbally presented with a random series of digits and asked to repeat them in the same order presented (forward span), in the reverse order (backward span), or ascending order (serial span). The raw score is determined by the number of the correct items and is transformed into a scaled score ranging from 1 to 19. Higher scores indicate better performance.
At baseline, at week 9, and at 3-month follow-up.
Change scores of Stroop Color-Word Test
Time Frame: At baseline, at week 9, and at 3-month follow-up.
The examinee is instructed to read words or to name the ink colors as quickly as possible within a specified time limit. The Stroop Color-Word Test consists of congruent and incongruent stimuli. Reaction time and errors on congruent and incongruent trials are recorded. A more minor time difference between congruent and incongruent trials indicates better executive function
At baseline, at week 9, and at 3-month follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Presence Questionnaire
Time Frame: The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
The questionnaire evaluates the extent to which participants feel a sense of presence within the virtual environment. It comprises 17 items grouped into three categories: involved/control, natural, and interface quality. It employs a seven-point Likert scale, and the score ranges from 17 to 119. Higher scores indicate a stronger sense of presence.
The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
Immersive Tendencies Questionnaire
Time Frame: The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
The questionnaire measures participants' capacity to immerse or engage in the virtual environment fully. It comprises 16 items distributed across three subscales: involvement, focus, and games. It employs a seven-point Likert scale, the score ranges from 16 to 112. Higher scores indicate a greater tendency to become immersed.
The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
Simulator Sickness Questionnaire
Time Frame: The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
The questionnaire assesses any adverse effects or discomfort experienced by participants during their interaction with the virtual environment. It encompasses 16 items categorized into three subscales: oculomotor, disorientation, and nausea. Each item is rated on a scale from 0 to 3, and the overall score ranges from 0 to 48. Higher scores indicate higher discomfort
The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
Technology Acceptance
Time Frame: The initial, second, fifth, ninth, thirteenth, and final intervention sessions.
The questionnaire assesses an individual's confidence and attitude levels toward technology. Seven sub-scales will be used, including Perceived Ease of Use (4 items), Perceptions of External Control (4 items), Computer Anxiety (4 items), Perceived Enjoyment (3 items), Output Quality (3 items), Result Demonstrability (4 items), and Behavioral Intention (3 items). It employs a seven-point Likert scale, the score ranges from 25 to 175. Higher scores indicate a higher technology acceptance.
The initial, second, fifth, ninth, thirteenth, and final intervention sessions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Da-Yeh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DaYehU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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