Feasibility Study of Mixed Reality Exergame on Performance and Cortical Outcomes

Not Applicable

• Conditions: Executive Dysfunction; Mild Cognitive Impairment (MCI)

• Registration Number: NCT06843733
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-27
• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Primary Completion: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Visual attention and task switching	before and immediately after intervention	Trail Making Test
Inhibitory control	before and immediately after intervention	Color-Word Stroop Test
Single-task performance	before and immediately after intervention	Box and Block Test
Dual-task performance	before and immediately after intervention	Box and Block with Serial Sevens Test
Cortical outcomes	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.
Usability	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.
Motivation	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.
Adverse side effects	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.

Trial Locations

Locations (1)

Faculty of Physical Therapy, Mahidol University; 🇹🇭 Salaya, Nakhon Pathom, Thailand