Neuromuscular PerformancePED-VR-EMGNCT07916155
Effects of Virtual Reality Exergaming on Reaction Time, Physical Performance, and Muscle Activity in Children
A study testing Immersive Virtual Reality Exergaming in people with Neuromuscular Performance and Reaction Time, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Performance, Reaction Time, Postural Balance
- What is being tested?
- Immersive Virtual Reality Exergaming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteRomania
- Study dates
- 10 Nov 2026to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion Criteria:
- Children aged 10-14 years, inclusive, regardless of sex.
- Participants belonging to one of the following athletic-background categories:
- Rhythmic gymnasts: Children currently participating in organized competitive rhythmic gymnastics training.
- Other competitive athletes: Children currently participating in organized competitive sports other than rhythmic gymnastics.
- Non-athlete children: Children who have not participated in organized sports training during the preceding six months.
Show all 11Show fewer
- Ability to safely participate in the assigned virtual reality or non-virtual-reality physical activity intervention.
- Ability to perform the computerized choice reaction time test, Five Times Sit-to-Stand test, and single-leg balance assessment.
- Ability to understand and follow age-appropriate instructions for the study procedures.
- Written informed consent provided by a parent or legal guardian.
- Age-appropriate informed assent provided by the participating child.
Who cannot join
- Current musculoskeletal injury, pain, or physical limitation that could compromise safe participation or substantially affect the study assessments.
- History of photosensitive epilepsy, visually triggered seizures, or another medical contraindication to immersive virtual reality exposure.
- Diagnosed vestibular disorders, severe susceptibility to motion sickness, or previous severe adverse reactions to virtual reality exposure.
- Uncorrected visual impairment that prevents safe use of the virtual reality headset or accurate completion of the computerized reaction time assessment.
- Neurological or other medical conditions that substantially interfere with the ability to complete the study procedures safely or meaningfully.
- Skin conditions, active lesions, or known adhesive allergies that prevent safe placement of surface electromyography electrodes.
Show all 9Show fewer
- Any other medical condition identified during screening that makes participation in the assigned physical activity unsafe.
- Refusal to participate or withdrawal of parental consent or child assent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
GH Kineto
Cluj-Napoca, Cluj, 400677
Horatiu D Ghejan, MSc, 0757758088, horatiughejan@yahoo.com
Pasc Gabriela, MsC, 0755344585, ohsportcomplex@yahoo.com
About this study
Official title: Acute Effects of Immersive Virtual Reality Exergaming Versus Matched Non-Virtual-Reality Exercise on Reaction Time, Functional Performance, Postural Control, and Neuromuscular Activity in Children Aged 10-14 Years: A Stratified Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Neuromuscular Performance, Reaction Time, Postural Balance
- Being tested
- Immersive Virtual Reality Exergaming
- Keywords
- Virtual Reality Exergaming, Beat Saber, Surface Electromyography, Neuromuscular Activation, Reaction Time, Randomized Controlled Trial, Pediatric Athletes, Rhythmic Gymnastics, Functional Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality ExergamingBehavioural
Also called Beat Saber
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.
Immersive Virtual Reality ExergamingBehavioural
Also called Matched Non-Virtual-Reality Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Exergaming | Experimental | 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. Receives: Behavioral: Immersive Virtual Reality Exergaming |
| Active Comparator | Active comparator | 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. Receives: Behavioral: Immersive Virtual Reality Exergaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a two-arm, parallel-group randomized controlled design, stratified by athletic background. A total of 360 children aged 10-14 years will be recruited from three populations: rhythmic gymnasts (n = 120), athletes participating in other competitive sports (n = 120), and sedentary children (n = 120). Within each athletic-background stratum, participants will be randomly assigned in a 1:1 ratio to either immersive virtual reality (VR) exergaming or a duration-matched non-VR physical activity intervention, with a planned allocation of 60 participants per intervention arm within each stratum. Random allocation sequences will be computer-generated using R Commander (Rcmdr), an interface for R statistical software. Each participant will complete a single testing session consisting of baseline assessments, the assigned intervention, and immediate post-intervention assessments. Athletic background will serve as a stratification variable and will not be randomly assigned.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghejan Horatiu Dacian, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916155
- Sponsor's protocol ID
- PED-VR-EMG-2026-01
- Acronym
- PED-VR-EMG
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Baba A, Smith M, Potter BK, Chan AW, Moher D, Toulany A, Doherty-Kirby A, Nafria Escalera B, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy P, Feneberg R, Poluru R, Morris SK, Friedrichsdorf SJ, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials. BMJ. 2026 Feb 24;392:e085061. doi: 10.1136/bmj-2025-085061. No abstract available.
PubMed 41734966Besomi M, Hodges PW, Clancy EA, Van Dieen J, Hug F, Lowery M, Merletti R, Sogaard K, Wrigley T, Besier T, Carson RG, Disselhorst-Klug C, Enoka RM, Falla D, Farina D, Gandevia S, Holobar A, Kiernan MC, McGill K, Perreault E, Rothwell JC, Tucker K. Consensus for experimental design in electromyography (CEDE) project: Amplitude normalization matrix. J Electromyogr Kinesiol. 2020 Aug;53:102438. doi: 10.1016/j.jelekin.2020.102438. Epub 2020 Jun 10.
PubMed 32569878Best JR. Exergaming immediately enhances children's executive function. Dev Psychol. 2012 Sep;48(5):1501-10. doi: 10.1037/a0026648. Epub 2011 Dec 12.
PubMed 22148945Anzeneder S, Zehnder C, Schmid J, Martin-Niedecken AL, Schmidt M, Benzing V. Dose-response relation between the duration of a cognitively challenging bout of physical exercise and children's cognition. Scand J Med Sci Sports. 2023 Aug;33(8):1439-1451. doi: 10.1111/sms.14370. Epub 2023 Apr 23.
PubMed 37088931
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Immersive Virtual Reality Exergaming Versus Matched Non-Virtual-Reality Exercise on Reaction Time, Functional Performance, Postural Control, and Neuromuscular Activity in Children Aged 10-14 Years: A Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07916155
- Acronym / sponsor ID
- PED-VR-EMG / PED-VR-EMG-2026-01
- Conditions
- Neuromuscular Performance, Reaction Time, Postural Balance
- Keywords
- Virtual Reality Exergaming, Beat Saber, Surface Electromyography, Neuromuscular Activation, Reaction Time, Randomized Controlled Trial, Pediatric Athletes, Rhythmic Gymnastics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a two-arm, parallel-group randomized controlled design, stratified by athletic background. A total of 360 children aged 10-14 years will be recruited from three populations: rhythmic gymnasts (n = 120), athletes participating in other competitive sports (n = 120), and sedentary children (n = 120). Within each athletic-background stratum, participants will be randomly assigned in a 1:1 ratio to either immersive virtual reality (VR) exergaming or a duration-matched non-VR physical activity intervention, with a planned allocation of 60 participants per intervention arm within each stratum. Random allocation sequences will be computer-generated using R Commander (Rcmdr), an interface for R statistical software. Each participant will complete a single testing session consisting of baseline assessments, the assigned intervention, and immediate post-intervention assessments. Athletic background will serve as a stratification variable and will not be randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Exergaming | Experimental | Behavioral: Immersive Virtual Reality ExergamingParticipants 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. |
| Active Comparator | Active comparator | Behavioral: Immersive Virtual Reality ExergamingParticipants 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Inclusion Criteria:
- Children aged 10-14 years, inclusive, regardless of sex.
- Participants belonging to one of the following athletic-background categories:
- Rhythmic gymnasts: Children currently participating in organized competitive rhythmic gymnastics training.
- Other competitive athletes: Children currently participating in organized competitive sports other than rhythmic gymnastics.
Key exclusion criteria (9 listed)
- Current musculoskeletal injury, pain, or physical limitation that could compromise safe participation or substantially affect the study assessments.
- History of photosensitive epilepsy, visually triggered seizures, or another medical contraindication to immersive virtual reality exposure.
- Diagnosed vestibular disorders, severe susceptibility to motion sickness, or previous severe adverse reactions to virtual reality exposure.
- Uncorrected visual impairment that prevents safe use of the virtual reality headset or accurate completion of the computerized reaction time assessment.
- Neurological or other medical conditions that substantially interfere with the ability to complete the study procedures safely or meaningfully.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality ExergamingAlso: Beat SaberParticipants 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. | Behavioural | Immersive Virtual Reality Exergaming |
| Immersive Virtual Reality ExergamingAlso: Matched Non-Virtual-Reality ExerciseParticipants 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. | Behavioural | Active Comparator |
Primary outcome
Change From Baseline in Median Choice Reaction Time (Milliseconds)
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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.
3 secondary outcomes
Change From Baseline in Five Times Sit-to-Stand Completion Time (Seconds)
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)
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
Time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 41734966Baba A, Smith M, Potter BK, Chan AW, Moher D, Toulany A, Doherty-Kirby A, Nafria Escalera B, Stratton C, Gale C, Macarthur C, Purper-Ouakil D, Juszczak E, Cohen E, Reggiardo G, Preston J, Cohen JF, Upton J, Allegaert K, Boerner K, Mehta K, Nguyen KA, Courtney K, Hartling L, Konstantinidis M, Odermarsky M, Butcher NJ, Kolehmainen N, Longmuir PE, Gill PJ, Leroy P, Feneberg R, Poluru R, Morris SK, Friedrichsdorf SJ, Chute Nagy T, Klassen TP, Lacaze-Masmonteil T, Onland W, Offringa M. CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials. BMJ. 2026 Feb 24;392:e085061. doi: 10.1136/bmj-2025-085061. No abstract available.
- Background: PubMed 32569878Besomi M, Hodges PW, Clancy EA, Van Dieen J, Hug F, Lowery M, Merletti R, Sogaard K, Wrigley T, Besier T, Carson RG, Disselhorst-Klug C, Enoka RM, Falla D, Farina D, Gandevia S, Holobar A, Kiernan MC, McGill K, Perreault E, Rothwell JC, Tucker K. Consensus for experimental design in electromyography (CEDE) project: Amplitude normalization matrix. J Electromyogr Kinesiol. 2020 Aug;53:102438. doi: 10.1016/j.jelekin.2020.102438. Epub 2020 Jun 10.
- Background: PubMed 22148945Best JR. Exergaming immediately enhances children's executive function. Dev Psychol. 2012 Sep;48(5):1501-10. doi: 10.1037/a0026648. Epub 2011 Dec 12.
- Background: PubMed 37088931Anzeneder S, Zehnder C, Schmid J, Martin-Niedecken AL, Schmidt M, Benzing V. Dose-response relation between the duration of a cognitively challenging bout of physical exercise and children's cognition. Scand J Med Sci Sports. 2023 Aug;33(8):1439-1451. doi: 10.1111/sms.14370. Epub 2023 Apr 23.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Exergaming in people with Neuromuscular Performance and Reaction Time, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Horatiu D Ghejan, MSc (0757758088, horatiughejan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Median Choice Reaction Time (Milliseconds) (time frame: Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07916155, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.