Executive DysfunctionNCT06843733
Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes
A study testing Mixed reality exergame and Education in people with Executive Dysfunction and Mild Cognitive Impairment (MCI), run by Mahidol University at 1 site in Thailand.
Trial summary
The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Executive Dysfunction, Mild Cognitive Impairment (MCI)
- What is being tested?
- Mixed reality exergame and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteThailand
- Study dates
- 27 May 2024to 2 May 2025
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy group: 1) MoCA score > 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.
- MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.
Who cannot join
- Uncontrolled high blood pressure (more than 140/90 mmHg)
- Hemodialysis
- Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.
- History of neurological disorder, such as stroke or other neurodegenerative disorder
- Taking medicine which affected to functional movement.
- Unable to follow study protocol.
- Uncorrected visual or hearing impairment.
- Positive screening for contraindication of TMS which will be confirmed by TMS screening questionnaire such as uncontrolled seizures.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People With Mild Cognitive Impairment
The executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.
- Being tested
- Mixed reality exergame, Education
- Keywords
- Feasibility study, Mixed reality, Mild cognitive impairment, Executive Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed reality exergameOther
The participants will play the Balloon Popping game using Hololens2 (Mixed reality glasses) for one hour. The objective of this game will be to pop all the virtual balloons, focusing on training different executive functions such as inhibitory control and cognitive flexibility. When a participant raises a finger in the air, a virtual needle will appear. After that, the participant will move their finger towards a balloon. Successful contact with a balloon will be indicated by the sound of a pop and the visual effect of confetti.
EducationOther
The participants will seat on a chair and watch video clip about MCI and dementia for one hour.
| Study group | Role | What they receive |
|---|---|---|
| Mild cognitive impairment | Experimental | Not described Receives: Other: Mixed reality exergame; Other: Education |
| Healthy older adults | Other | Not described Receives: Other: Mixed reality exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual attention and task switching
Trail Making Test
Measured: before and immediately after intervention
Inhibitory control
Color-Word Stroop Test
Measured: before and immediately after intervention
Single-task performance
Box and Block Test
Measured: before and immediately after intervention
Dual-task performance
Box and Block with Serial Sevens Test
Measured: before and immediately after intervention
Cortical outcomes
Transcranial magnetic stimulation was used for measuring the cortical outcomes, which consist of resting motor threshold, input-output curve of motor evoked potentials recruitment and cortical silent period.
Measured: before and immediately after intervention
Usability
System usability scale questionnaire was used for measuring the usability of mixed reality exergame. It consists of 10-item, which are typically rated on a five-point scale. A higher SUS score generally indicates better usability.
Measured: immediately after Mixed reality exergaming
Motivation
Intrinsic Motivation Inventory was used for measuring the motivation. It rated on seven-point scale. Higher IMI scores reflect higher levels of motivation.
Measured: immediately after Mixed reality exergaming
Adverse side effects
Cybersickness in Virtual Reality Questionnaire was used for assessing cybersickness symptoms, including nausea, vestibular, and oculomotor. The total score is the sum of the three sub-scores. Each question is presented on a 7-item Likert Scale.
Measured: immediately after Mixed reality exergaming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start27 May 2024
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rommanee Rojasavastera, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843733
- Sponsor's protocol ID
- MU-CIRB 2024/060.2102
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share IPD when we receive the consent from participants.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06843733
- Acronym / sponsor ID
- MU-CIRB 2024/060.2102
- Keywords
- Feasibility study, Mixed reality, Mild cognitive impairment, Executive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 25 Feb 2025 (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 executive dysfunctions are a problem in individuals with MCI which predict conversion to dementia and is positively related to physical activity level. Previous studies found that exercise can prevent executive and physical dysfunctions for people with MCI. However, the motivation is a critical factor in supporting a sustainable exercise. Exergame is combination of exercise and video game. Enjoyment during playing an exergame can support the exercise motivation. Therefore, we will explore the feasibility of using MR exergame in people with MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild cognitive impairment | Experimental | Other: Mixed reality exergame, Other: Education |
| Healthy older adults | Other | Other: Mixed reality exergame |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy group: 1) MoCA score > 24; 2) Independent walking without using gait aids; 3) No diagnosis of the dementia by clinician.
- MCI group: 1) MoCA score between 16 to 24; 2) Independent walking without using gait aids.
Key exclusion criteria (8 listed)
- Uncontrolled high blood pressure (more than 140/90 mmHg)
- Hemodialysis
- Have clinical diagnosis of the disease or symptoms that could influence the performance assessments such as arthritis or severe hand pain which reports by participants and the testing by physiotherapist before testing.
- History of neurological disorder, such as stroke or other neurodegenerative disorder
- Taking medicine which affected to functional movement.
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 |
|---|---|---|
| Mixed reality exergameThe participants will play the Balloon Popping game using Hololens2 (Mixed reality glasses) for one hour. The objective of this game will be to pop all the virtual balloons, focusing on training different executive functions such as inhibitory control and cognitive flexibility. When a participant raises a finger in the air, a virtual needle will appear. After that, the participant will move their finger towards a balloon. Successful contact with a balloon will be indicated by the sound of a pop and the visual effect of confetti. | Other | Healthy older adults, Mild cognitive impairment |
| EducationThe participants will seat on a chair and watch video clip about MCI and dementia for one hour. | Other | Mild cognitive impairment |
Primary outcome
Visual attention and task switching
Time frame: before and immediately after intervention
Trail Making Test
Inhibitory control
Time frame: before and immediately after intervention
Color-Word Stroop Test
Single-task performance
Time frame: before and immediately after intervention
Box and Block Test
Dual-task performance
Time frame: before and immediately after intervention
Box and Block with Serial Sevens Test
Cortical outcomes
Time frame: before and immediately after intervention
Transcranial magnetic stimulation was used for measuring the cortical outcomes, which consist of resting motor threshold, input-output curve of motor evoked potentials recruitment and cortical silent period.
Usability
Time frame: immediately after Mixed reality exergaming
System usability scale questionnaire was used for measuring the usability of mixed reality exergame. It consists of 10-item, which are typically rated on a five-point scale. A higher SUS score generally indicates better usability.
Motivation
Time frame: immediately after Mixed reality exergaming
Intrinsic Motivation Inventory was used for measuring the motivation. It rated on seven-point scale. Higher IMI scores reflect higher levels of motivation.
Adverse side effects
Time frame: immediately after Mixed reality exergaming
Cybersickness in Virtual Reality Questionnaire was used for assessing cybersickness symptoms, including nausea, vestibular, and oculomotor. The total score is the sum of the three sub-scores. Each question is presented on a 7-item Likert Scale.
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided. We will share IPD when we receive the consent from participants.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed reality exergame and Education in people with Executive Dysfunction and Mild Cognitive Impairment (MCI), run by Mahidol University at 1 site in Thailand.
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 2 inclusion and 8 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 22 Jun 2026. 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 Thailand. 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?
Visual attention and task switching (time frame: before and immediately after intervention). The study lists 8 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 22 Jun 2026.