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

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 Overview

• Status: Enrolling by invitation
• Conditions: Mild Cognitive Impairment (MCI); Executive Dysfunction
• Intervention / Treatment: Other: Mixed reality exergame; Other: Education

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Nakhon Pathom
    • Salaya, Nakhon Pathom, Thailand, 73170
      • Faculty of Physical Therapy, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild cognitive impairment	Other: Mixed 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.; Other: Education; The participants will seat on a chair and watch video clip about MCI and dementia for one hour.
Other: Healthy older adults	Other: Mixed 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual attention and task switching	Trail Making Test	before and immediately after intervention
Inhibitory control	Color-Word Stroop Test	before and immediately after intervention
Single-task performance	Box and Block Test	before and immediately after intervention
Dual-task performance	Box and Block with Serial Sevens Test	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.	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.	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.	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.	immediately after Mixed reality exergaming

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Mild cognitive impairment; Feasibility study; Executive Dysfunction; Mixed reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: MU-CIRB 2024/060.2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will share IPD when we receive the consent from participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No