Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes

NCT06843733 | Enrolling By Invitation

• 1 other identifier: MU-CIRB 2024/060.2102
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Dysfunction; Mild Cognitive Impairment (MCI)

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Mild cognitive impairment

EXPERIMENTAL

Other: Mixed reality exergame; Other: Education

Healthy older adults

OTHER

Other: Mixed reality exergame

Interventions

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.

Healthy older adults; Mild cognitive impairment

Education OTHER

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

Mild cognitive impairment

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty of Physical Therapy, Mahidol University

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: May 27, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 31, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

TH (1)