Effects of Virtual Reality Exergaming on Reaction Time, Physical Performance, and Muscle Activity in Children (PED-VR-EMG)
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.
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Horatiu D Ghejan, MSc
- 電話番号：0757758088
- メール：horatiughejan@yahoo.com
研究場所
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Cluj
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Cluj-Napoca、Cluj、ルーマニア、400677
- GH Kineto
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コンタクト：
- Horatiu D Ghejan, MSc
- 電話番号：0757758088
- メール：horatiughejan@yahoo.com
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コンタクト：
- Pasc Gabriela, MsC
- 電話番号：0755344585
- メール：ohsportcomplex@yahoo.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- **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.
- 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.
**Exclusion Criteria:**
- 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.
- 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.
Exclusion Criteria:
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研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Immersive Virtual Reality Exergaming
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. |
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.
他の名前：
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.
他の名前：
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アクティブコンパレータ：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. |
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.
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Median Choice Reaction Time (Milliseconds)
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Five Times Sit-to-Stand Completion Time (Seconds)
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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Change From Baseline in Single-Leg Stance Balance Errors (Number of Errors per Trial)
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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Change From Baseline in Bilateral Rectus Femoris Normalized sEMG Amplitude During Five Times Sit-to-Stand
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline in Shank Angular Velocity Variability During Single-Leg Stance
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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Change From Baseline in Choice Reaction Time Response Accuracy (Percentage)
時間枠：Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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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. |
Baseline (before intervention) and within 30 minutes after the assigned intervention, during the same study visit.
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
- Besomi 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.
- Best JR. Exergaming immediately enhances children's executive function. Dev Psychol. 2012 Sep;48(5):1501-10. doi: 10.1037/a0026648. Epub 2011 Dec 12.
- Anzeneder 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- PED-VR-EMG-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。