Mild Cognitive ImpairmentNCT06392412
Virtual Reality Cognitive Training for Older Adults With Mild Cognitive Impairment
A study testing fi-VR Cognitive Training and Traditional Cognitive Training in people with Mild Cognitive Impairment and Older Adults, run by Da-Yeh University.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Older Adults
- What is being tested?
- fi-VR Cognitive Training and Traditional Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 or above.
- MoCA score between 18 and 25.
- Capability to follow directions and do tasks.
Who cannot join
- History of dementia.
- Previous neurodegenerative illness diagnosis.
- Severe medical or surgical problems.
- Major psychological disorders.
- Inability to use VR system
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Older Adults
- Being tested
- fi-VR Cognitive Training, Traditional Cognitive Training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fi-VR Cognitive TrainingBehavioural
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.
Traditional Cognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | Not described Receives: Behavioral: fi-VR Cognitive Training |
| Control Group | Active comparator | Not described Receives: Behavioral: Traditional Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, at week 9, and at 3-month follow-up.
Secondary outcomes (2)
Change scores of Digit Span
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.
Measured: At baseline, at week 9, and at 3-month follow-up.
Change scores of Stroop Color-Word Test
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
Measured: At baseline, at week 9, and at 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Da-Yeh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Chen Chen, Da-Yeh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392412
- Sponsor's protocol ID
- DaYehU
- Status last verified
- Jul 2024
- First submitted
- 26 Apr 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39539569
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fully Immersive Virtual Reality Cognitive Training Based on Instrumental Activities of Daily Living for Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06392412
- Acronym / sponsor ID
- DaYehU
- Conditions
- Mild Cognitive Impairment, Older Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Da-Yeh UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Behavioral: fi-VR Cognitive Training |
| Control Group | Active comparator | Behavioral: Traditional Cognitive Training |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 or above.
- MoCA score between 18 and 25.
- Capability to follow directions and do tasks.
Key exclusion criteria (5 listed)
- History of dementia.
- Previous neurodegenerative illness diagnosis.
- Severe medical or surgical problems.
- Major psychological disorders.
- Inability to use VR system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fi-VR Cognitive TrainingAll 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. | Behavioural | VR Group |
| Traditional Cognitive TrainingAll 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. | Behavioural | Control Group |
Primary outcome
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
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.
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.
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.
2 secondary outcomes
Change scores of Digit Span
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Derived from this study: PubMed 39539569Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing fi-VR Cognitive Training and Traditional Cognitive Training in people with Mild Cognitive Impairment and Older Adults, run by Da-Yeh University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes scores of Montreal Cognitive Assessment (MoCA) (time frame: At baseline, at week 9, and at 3-month follow-up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06392412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.