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Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes

Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes in Healthy Older Adults and People With Mild Cognitive Impairment

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06843733
Enrollment
42
Registered
2025-02-25
Start date
2024-05-27
Completion date
2025-05-02
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Executive Dysfunction, Mild Cognitive Impairment (MCI)

Keywords

Feasibility study, Mixed reality, Mild cognitive impairment, Executive Dysfunction

Brief 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.

Interventions

OTHERMixed reality exergame

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.

OTHEREducation

The participants will seat on a chair and watch video clip about MCI and dementia for one hour.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual attention and task switchingbefore and immediately after interventionTrail Making Test
Inhibitory controlbefore and immediately after interventionColor-Word Stroop Test
Single-task performancebefore and immediately after interventionBox and Block Test
Dual-task performancebefore and immediately after interventionBox and Block with Serial Sevens Test
Cortical outcomesbefore and immediately after interventionTranscranial 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.
Usabilityimmediately after Mixed reality exergamingSystem 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.
Motivationimmediately after Mixed reality exergamingIntrinsic Motivation Inventory was used for measuring the motivation. It rated on seven-point scale. Higher IMI scores reflect higher levels of motivation.
Adverse side effectsimmediately after Mixed reality exergamingCybersickness 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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026