Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes (NCT06843733) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes
Thailand42 participantsStarted 2024-05-27
Plain-language 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. 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.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual attention and task switching
Timeframe: before and immediately after intervention
2
Inhibitory control
Timeframe: before and immediately after intervention
3
Single-task performance
Timeframe: before and immediately after intervention
4
Dual-task performance
Timeframe: before and immediately after intervention
5
Cortical outcomes
Timeframe: before and immediately after intervention
6
Usability
Timeframe: immediately after Mixed reality exergaming
7
Motivation
Timeframe: immediately after Mixed reality exergaming