Virtual RealityNCT05329272
Virtual Reality Training Intervention on Cognitive Function and Quality of Life
A study testing Virtual Reality Cognitive Training Intervention (VRCTI) in people with Virtual Reality and Cognitive Impairment, run by I-Shou University at 1 site in Taiwan.
Trial summary
The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Virtual Reality, Cognitive Impairment, Quality of Life
- What is being tested?
- Virtual Reality Cognitive Training Intervention (VRCTI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥ 65 years
- Admitted as residents at the study-site institutions (long-term care facilities)
- Mini Mental Status Examination (MMSE) ≥ 13
- Able to communicate sufficiently
Who cannot join
- Open facial wounds
- Problems with a finger, hand, or wrist and/or major visual or auditory impairment, making it difficult to deliver training scheme
- Major neurological or psychiatric conditions that may affect cognition (e.g., stroke, dizziness, schizophrenia)
- Unstable medical conditions
- Were unable to comply with the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Incorporating Virtual Reality Training Intervention Into Health Care on Cognitive Function and Quality of Life in Older Adults With Cognitive Impairment: A Randomized Controlled Trial
The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities. Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The passive control group received usual care.
Read the detailed description
Objectives: The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities.
Method: Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The VRCTI comprised 12 different tasks distributed in 8 sessions with different difficulty levels. The passive control group received usual care. Older adults were randomly assigned to either VR or control groups. An experimental pre-post design was used. Accuracy, error, and repetition rates were measured throughout each session. Intervention effects were analyzed using a generalized estimating equation model.
- Conditions
- Virtual Reality, Cognitive Impairment, Quality of Life
- Being tested
- Virtual Reality Cognitive Training Intervention (VRCTI)
- Keywords
- Virtual Reality, Cognitive Impairment, Quality of Life, Long-term care facilities
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Cognitive Training Intervention (VRCTI)Other
The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display [HMD] in delivering the VR intervention), audio, and motor equipment.
| Study group | Role | What they receive |
|---|---|---|
| The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI) | Experimental | The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display [HMD] in delivering the VR intervention), audio, and motor equipment. Receives: Other: Virtual Reality Cognitive Training Intervention (VRCTI) |
| The control group | No intervention | The control group received usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Assessment Screening Instrument (CASI)
The CASI evaluates global cognitive function using 9 cognitive domains: long-term memory, short-term memory, attention, mental manipulation, orientation, abstraction and judgment, language abilities, visual construction, and list-generating fluency. Typical administration time is about 20 minutes. The total score ranges from 0 to 100. A greater score demonstrates better global cognitive function.
Measured: Change is being assessed. Change in Cognitive Assessment Screening Instrument (CASI) from baseline to immediately after the intervention.
Mini-Mental State Examination (MMSE)
General cognitive functioning was assessed with the Chinese version of the MMSE, which is a cognitive screening tool used to evaluate cognitive decline, screen for cognitive impairment, to evaluate the severity of the impairment, and to monitor cognitive change over time. The higher score indicates the better cognitive function.
Measured: Change is being assessed. Change in Mini-Mental State Examination (MMSE) from baseline to immediately after the intervention.
Clock Drawing Test-Drawing Part, (CDT-D)
The CDT-D has been widely used as a neuropsychological screening test in the detection of cognitive impairment in populations. The lower the patients' clock scores the more likely were patients to be classified as impaired in elderly outpatients.
Measured: Change is being assessed. Change in Clock Drawing Test-Drawing Part, (CDT-D) from baseline to immediately after the intervention.
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
The WHOQOL-BREF contains 28 items classified into the same 4 domains related to quality of life (physical health, psychological, social relationships and environment). All items were rated on a 5-point scale with a higher score indicating a higher quality of life.
Measured: Change is being assessed. Change in World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF) from baseline to immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study startJan 2017
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Shou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Chi Hsu, I-Shou University
- Investigators
- Mei-Chi Hsu, Ph.D, Principal investigator, I-Shou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329272
- Sponsor's protocol ID
- IShouU-VR
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data presented in this study are available on request from the researcher. The data are not publicly available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Incorporating Virtual Reality Training Intervention Into Health Care on Cognitive Function and Quality of Life in Older Adults With Cognitive Impairment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05329272
- Acronym / sponsor ID
- IShouU-VR
- Conditions
- Virtual Reality, Cognitive Impairment, Quality of Life
- Keywords
- Virtual Reality, Cognitive Impairment, Quality of Life, Long-term care facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I-Shou UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Apr 2022 (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.
The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities. Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The passive control group received usual care.
Detailed description
Objectives: The present study aimed to investigate the effects of a Virtual Reality cognitive training intervention (VRCTI) on cognitive function changes measured with a cognitive test battery and improvement of quality of life in older adults with cognitive impairment in long-term care facilities.
Method: Weekly 1-hour sessions were implemented over 8 weeks targeting sustained and selective attention, memory, cognitive functions, and rule deduction. The VRCTI comprised 12 different tasks distributed in 8 sessions with different difficulty levels. The passive control group received usual care. Older adults were randomly assigned to either VR or control groups. An experimental pre-post design was used. Accuracy, error, and repetition rates were measured throughout each session. Intervention effects were analyzed using a generalized estimating equation model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI) | Experimental | Other: Virtual Reality Cognitive Training Intervention (VRCTI)The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display [HMD] in delivering the VR intervention), audio, and motor equipment. |
| The control group | No intervention | –The control group received usual care. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 65 years
- Admitted as residents at the study-site institutions (long-term care facilities)
- Mini Mental Status Examination (MMSE) ≥ 13
- Able to communicate sufficiently
Key exclusion criteria (5 listed)
- Open facial wounds
- Problems with a finger, hand, or wrist and/or major visual or auditory impairment, making it difficult to deliver training scheme
- Major neurological or psychiatric conditions that may affect cognition (e.g., stroke, dizziness, schizophrenia)
- Unstable medical conditions
- Were unable to comply with the intervention
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 |
|---|---|---|
| Virtual Reality Cognitive Training Intervention (VRCTI)The VRCTI was developed to improve cognitive function. The intervention was designed that simulated schema of underwater world fish swimming. Each 1-hour session was typically divided into three parts: easy, medium and difficult, each with 4 different tasks, so there are 12 tasks/session in total. In some tasks, the VRCTI also distinguished between the real lure (e.g. a red triangle fish with a half-moon pattern) as well as unrelated lure items (i.e., blue square fish with polka dot pattern and other irrelevant items). The use of hardware elements for this study included visual (head-mounted display [HMD] in delivering the VR intervention), audio, and motor equipment. | Other | The VR group: the Virtual Reality Cognitive Training Intervention (VRCTI) |
Primary outcome
Cognitive Assessment Screening Instrument (CASI)
Time frame: Change is being assessed. Change in Cognitive Assessment Screening Instrument (CASI) from baseline to immediately after the intervention.
The CASI evaluates global cognitive function using 9 cognitive domains: long-term memory, short-term memory, attention, mental manipulation, orientation, abstraction and judgment, language abilities, visual construction, and list-generating fluency. Typical administration time is about 20 minutes. The total score ranges from 0 to 100. A greater score demonstrates better global cognitive function.
Mini-Mental State Examination (MMSE)
Time frame: Change is being assessed. Change in Mini-Mental State Examination (MMSE) from baseline to immediately after the intervention.
General cognitive functioning was assessed with the Chinese version of the MMSE, which is a cognitive screening tool used to evaluate cognitive decline, screen for cognitive impairment, to evaluate the severity of the impairment, and to monitor cognitive change over time. The higher score indicates the better cognitive function.
Clock Drawing Test-Drawing Part, (CDT-D)
Time frame: Change is being assessed. Change in Clock Drawing Test-Drawing Part, (CDT-D) from baseline to immediately after the intervention.
The CDT-D has been widely used as a neuropsychological screening test in the detection of cognitive impairment in populations. The lower the patients' clock scores the more likely were patients to be classified as impaired in elderly outpatients.
World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)
Time frame: Change is being assessed. Change in World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF) from baseline to immediately after the intervention.
The WHOQOL-BREF contains 28 items classified into the same 4 domains related to quality of life (physical health, psychological, social relationships and environment). All items were rated on a 5-point scale with a higher score indicating a higher quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No. The data presented in this study are available on request from the researcher. The data are not publicly available due to privacy and ethical restrictions.
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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. This study is not recruiting at the moment.
Mei-Chi Hsu, Ph.D principal investigator
I-Shou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Cognitive Training Intervention (VRCTI) in people with Virtual Reality and Cognitive Impairment, run by I-Shou University at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Assessment Screening Instrument (CASI) (time frame: Change is being assessed. Change in Cognitive Assessment Screening Instrument (CASI) from baseline to immediately after the intervention.). 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?
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 14 Apr 2022.