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Completed

NCT Number: NCT06843733

Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes

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.

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Key information

Conditions

Executive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixed reality exergame

Other

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.

Education

Other

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

Primary outcomes

  1. Visual attention and task switching

    Time frame: before and immediately after intervention

    Trail Making Test

  2. Inhibitory control

    Time frame: before and immediately after intervention

    Color-Word Stroop Test

  3. Single-task performance

    Time frame: before and immediately after intervention

    Box and Block Test

  4. Dual-task performance

    Time frame: before and immediately after intervention

    Box and Block with Serial Sevens Test

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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