An interventional study of Immersive Virtual Reality Exergaming and Immersive Virtual Reality Exergaming in Neuromuscular Performance, Reaction Time and Postural Balance, sponsored by Babes-Bolyai University. Not yet recruiting at 1 site in Romania. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Basic science
This randomized controlled trial will investigate the immediate effects of virtual reality (VR) exergaming on reaction time, physical performance, balance, and muscle activity in children aged 10-14 years with different athletic backgrounds.
The study aims to enroll 360 children divided into three categories: 120 rhythmic gymnasts, 120 athletes participating in other competitive sports, and 120 children who do not regularly participate in organized sports. Within each category, participants will be randomly assigned to either a VR exergaming group or an active control group performing comparable physical movements without VR.
Each participant will attend one testing session. Before and after the assigned three-minute activity, children will complete three assessments: a computerized reaction time test, a Five Times Sit-to-Stand test, and a single-leg balance test. Small, noninvasive sensors placed on the arms and legs will record muscle electrical activity and movement characteristics during selected activities.
The primary objective is to determine whether VR exergaming produces different immediate changes in reaction time compared with similar physical activity performed without VR. Secondary objectives include evaluating changes in functional performance and postural control, examining muscle activation patterns, and investigating whether responses to VR differ according to athletic background.
The findings may improve understanding of the immediate cognitive-motor and neuromuscular responses to immersive VR activities in children.
Immersive virtual reality (VR) exergaming combines visually guided movement, rapid motor responses, and interactive task performance. Although VR-based activities are increasingly investigated in pediatric exercise and rehabilitation research, the immediate effects of brief VR exposure on neuromuscular activity, cognitive-motor performance, and postural control remain insufficiently understood. Furthermore, it is unclear whether children with different athletic backgrounds demonstrate comparable physiological and functional responses to the same VR intervention.
Rhythmic gymnastics involves substantial demands on postural control, coordination, balance, and movement precision. Athletes participating in other competitive sports may develop different neuromuscular characteristics, while children who do not regularly participate in organized sports may demonstrate different baseline motor abilities. Comparing these populations may help identify associations between previous athletic training and acute responses to immersive VR activities.
The study will use a stratified, parallel-group randomized controlled design. Randomization will be performed within each athletic-background category to compare immersive VR exergaming with a duration-matched, non-VR physical activity condition. The active comparison is intended to help distinguish responses associated with the VR intervention from those associated with physical movement and repeated assessment.
Surface electromyography (sEMG) and inertial measurement units (IMUs) will be used to characterize muscle activation and movement patterns. Bilateral measurements will be obtained from the gastrocnemius medialis, rectus femoris, and middle deltoid muscles. These recordings will allow the investigation of muscle-specific activation patterns, bilateral differences, and selected movement characteristics during standardized activities.
All participants will undergo assessments before and immediately after their assigned intervention. Standardized instructions, familiarization procedures, and consistent testing conditions will be used to reduce measurement variability and potential learning effects. The interval between intervention completion and each post-intervention assessment will be recorded.
The primary statistical analysis will compare post-intervention reaction time between randomized intervention groups while adjusting for baseline performance and athletic background. A prespecified intervention-by-athletic-background interaction will investigate whether the randomized intervention effect differs across the three populations. Functional performance, postural control, and neuromuscular measurements will be analyzed as secondary or exploratory outcomes according to the finalized statistical analysis plan.
Participant safety will be monitored throughout the testing session. Potential adverse events, including dizziness, nausea, visual discomfort, loss of balance, or musculoskeletal discomfort, will be documented. Testing will be discontinued if a participant experiences symptoms that could compromise safety.
The investigation is intended to provide evidence regarding the immediate responses to immersive VR exergaming in pediatric populations and to clarify whether athletic background is associated with differences in these responses.
Babes-Bolyai University is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
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- **Inclusion Criteria:**
**Exclusion Criteria:**
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to the experimental arm will complete a single, supervised, three-minute immersive virtual reality exergaming session using Beat Saber on a Meta Quest 3 headset at the Easy difficulty level. Surface electromyography and inertial measurement unit sensors will record muscle activation and movement characteristics during the intervention. Reaction time, functional lower-limb performance, and single-leg balance will be assessed before and immediately after the intervention. The experimental arm will include rhythmic gymnasts, athletes from other competitive sports, and sedentary children.
Behavioral: Immersive Virtual Reality Exergaming
Participants assigned to the active comparator arm will complete a single, supervised, three-minute non-virtual-reality exercise session designed to approximate the movement demands and duration of the VR intervention, without using an immersive headset. Surface electromyography and inertial measurement unit sensors will record muscle activation and movement characteristics during the intervention. The same reaction time, functional lower-limb performance, and single-leg balance assessments will be performed before and immediately after the intervention. The active comparator arm will include rhythmic gymnasts, athletes from other competitive sports, and sedentary children.
Behavioral: Immersive Virtual Reality Exergaming
Participants will perform one supervised session of immersive virtual reality exergaming using Beat Saber on a Meta Quest 3 headset. The intervention will consist of approximately three minutes of gameplay at the Easy difficulty level, using a standardized song and identical game settings for all participants. Surface electromyography and inertial measurement units will record muscle activation and movement characteristics during gameplay.
Also known as: Beat Saber
Participants will perform one supervised session of non-virtual-reality exercise lasting approximately three minutes. The exercise will be designed to reproduce the main upper-limb and lower-limb movement demands of the VR intervention without immersive visual stimulation. Instructions, exercise duration, and movement requirements will be standardized. Surface electromyography and inertial measurement units will record muscle activation and movement characteristics during the activity.
Also known as: Matched Non-Virtual-Reality Exercise
Change From Baseline in Median Choice Reaction Time (Milliseconds)
Choice reaction time will be measured using a computerized two-choice visual reaction time task. Following standardized familiarization, participants will complete 30 recorded trials requiring responses to visual stimuli. The median reaction time for correct responses will be calculated in milliseconds (ms). Individual change will be calculated as post-intervention minus baseline reaction time. Negative values indicate faster responses following the intervention.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Change From Baseline in Five Times Sit-to-Stand Completion Time (Seconds)
Functional lower-limb performance will be assessed using the Five Times Sit-to-Stand test. Participants will stand up from and sit down on a standardized chair five times as quickly as possible, with their arms crossed over the chest. Completion time will be recorded in seconds. Individual change will be calculated as post-intervention minus baseline completion time. Negative values indicate faster performance.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Change From Baseline in Single-Leg Stance Balance Errors (Number of Errors per Trial)
Static postural control will be assessed using a standardized single-leg stance test performed on a firm surface with eyes open and hands on hips. Participants will complete three 20-second trials on each leg. Balance errors, including touching the floor with the non-supporting foot, moving the supporting foot, or removing the hands from the hips, will be recorded. The mean number of errors per trial across six trials will be calculated. Individual change will be calculated as post-intervention minus baseline. Negative values indicate fewer balance errors.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Change From Baseline in Bilateral Rectus Femoris Normalized sEMG Amplitude During Five Times Sit-to-Stand
Surface electromyography (sEMG) will be recorded bilaterally from the rectus femoris during the Five Times Sit-to-Stand test. Root mean square (RMS) amplitude will be normalized to a standardized reference contraction and expressed as a percentage of the reference amplitude. Mean normalized RMS across both muscles will be calculated for each assessment. Individual change will be calculated as post-intervention minus baseline normalized RMS.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Change From Baseline in Shank Angular Velocity Variability During Single-Leg Stance
Inertial measurement units attached to the lower legs will record angular velocity during single-leg stance. The standard deviation of resultant three-dimensional shank angular speed will be calculated in degrees per second for each 20-second trial. Values will be averaged across six trials. Individual change will be calculated as post-intervention minus baseline angular velocity variability. This measure characterizes shank movement variability rather than direct center-of-pressure displacement.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Change From Baseline in Choice Reaction Time Response Accuracy (Percentage)
Response accuracy will be calculated as the percentage of correct responses across 30 recorded trials of the computerized choice reaction time task. Scores range from 0% to 100%, with higher values indicating greater accuracy. Individual change will be calculated as post-intervention minus baseline accuracy, expressed in percentage points.
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — De-identified individual participant data underlying the published study results and the corresponding data dictionary are planned to be made available to qualified researchers upon reasonable request following publication. Access will be subject to approval by the responsible research institution, applicable ethical and data protection requirements, and a data-sharing agreement. As the study involves children aged 10-14 years, only data that can be appropriately de-identified and shared in accordance with parental consent and applicable regulations will be considered for release.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
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Babes-Bolyai University