- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06646874
Active Video Game Influence Cognitive Ability
Active Video Game Using Virtual Reality Influence Cognitive Ability in Sedentary Female University Students: Randomized Clinical Trial
The experiment was conducted at the Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University between February 2024 and May 2024. During the briefing, all questions were answered to ensure that participants understood the experiment and its objectives. On the day of the experiment, demographic information was collected, including age, height, weight, body mass index (BMI), and preferred leg. An Eye-Level Weight Beam scale (Detecto, Webb City, MO, USA) was used to determine the weight and height of the subjects. To identify the preferred leg, participants were observed ascending stairs or kicking a ball.
Participants were recruited and assigned to one of two groups, either the control group or the VR group. Participants were required to attend one experimental session in a random order using Microsoft Excel's (Microsoft Corp., Redmond, WA, USA) random list function. The VR group was required to play a 20-minute game of Beat Saber VR, while the control group was asked to sit quietly for 20 minutes without any activities assigned. This study used an accelerometer from ActivPal (PAL Technologies Ltd, Glasgow, UK) to capture the PA levels of the VR group throughout the VR game. Following previously published validation studies and manufacturer recommendations, a strip of Tegaderm (3M, St. Paul, MN) was attached to the preferred leg's front thigh.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Central
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Al Kharj, Central, Saudi Arabia, 11942
- Human Biomechanics Laboratory of the College of Applied Medical Sciences of Prince Sattam bin Abdulaziz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female college students
- Low physical activity (inactive)
- Age (18 to 23 years)
- No previous medical condition affecting PA level
- No visual impairments
- Have never experienced the VR game used in the trial
Exclusion Criteria:
- Male students
- Physically active
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group
The control group completed the MoCA pre- and post-tests 20 minutes apart.
A debriefing was conducted for the participants following the conclusion of the experiment.
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Experimental: VR group
Each participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session.
Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2)
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Each participant in the VR group completed a five-minute familiarization session with the VR game before the experimental session.
Following the familiarization session, participants in the VR group were instructed to complete the Montreal Cognitive Assessment (MoCA) Arabic version (pre-test: Arabic version 8.1 and post-test: Arabic version 8.2)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Montreal Cognitive Assessment (MoCA)
Time Frame: 20 minutes
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Developed as a screening instrument to detect mild cognitive impairment, the Montreal Cognitive Assessment (MoCA) uses a series of questions to assess cognitive impairment.
A paper-and-pencil assessment is administered and scored out of 30 points.
In addition to attention, concentration, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation, the MoCA assesses several cognitive domains.
There are 56 languages and dialects translation of the MoCA and it is widely used throughout the world
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20 minutes
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ActivPal
Time Frame: 20 minutes
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The ActivPAL is a posture and activity tracker that uses a tri-axial accelerometer to measure movement and activity.
The device collects information such as bouts of sitting, lying, standing, and stepping, and allows data to be retrieved by week, day, or hour.
As a valid and reliable tool to detect PA, ActivPal can be used in a variety of populations and settings (64).
From the ActivPal, the following variables were collected for each participant in the VR group: total MET, total number of steps, total time stepping, number of sit-to-stands, and number of stands-to-sit.
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20 minutes
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RHPT/023/007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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