- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07655999
Effect of an Immersive Virtual Reality Physical Intervention Program on Reaction Time in Secondary School Students: A Pilot Study
Analysis of the Effect of a Physical Intervention Program Developed in Immersive Virtual Reality Environments on Reaction Times in Compulsory Secondary Education Students: A Pilot Study
The purpose of this pilot randomized controlled study is to evaluate the effects of an immersive virtual reality (IVR)-based physical intervention program on reaction time in secondary school students. Participants will be randomly assigned to either an experimental group, which will complete an immersive virtual reality training program using the Rezzil Player platform, or a control group that will continue their usual activities without virtual reality exposure.
The intervention will be conducted over eight weeks and will include progressive reaction-based tasks performed in immersive virtual reality environments. Outcomes will be assessed before and after the intervention through visual and auditory reaction time tests and the Symbol Digit Modalities Test (SDMT), a validated measure of cognitive processing speed and attention. The study aims to determine whether immersive virtual reality training can improve reaction performance and cognitive processing in adolescents and provide preliminary evidence regarding its feasibility and effectiveness as an educational and physical training tool.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Reaction time is a key component of motor performance and is closely associated with perceptual, cognitive, and decision-making processes. The ability to rapidly detect, process, and respond to external stimuli is particularly important during adolescence, a developmental stage characterized by significant cognitive and motor maturation. Emerging evidence suggests that immersive virtual reality (IVR) may provide an effective environment for training perceptual-motor skills due to its capacity to simulate dynamic and interactive scenarios while maintaining high levels of engagement and motivation.
Despite the increasing use of virtual reality in sport and physical activity settings, evidence regarding its effects on reaction time in adolescents remains limited. Therefore, this pilot study seeks to evaluate the effectiveness of an immersive virtual reality-based intervention program in improving reaction times among secondary school students.
The study will employ a randomized controlled design. Participants will be secondary school students aged between 12 and 16 years. Following baseline assessments, participants will be randomly allocated to either an experimental group or a control group. The experimental group will complete an 8-week intervention consisting of immersive virtual reality sessions using the Rezzil Player application. Training tasks will require participants to identify and respond as quickly as possible to visual stimuli presented in virtual environments of increasing complexity and spatial demands. The control group will not participate in any virtual reality-related activity during the intervention period.
Outcome measures will be collected before and after the intervention. Primary outcomes will include visual reaction time, auditory reaction time, and cognitive processing speed assessed through the Symbol Digit Modalities Test (SDMT). Secondary outcomes may include performance indicators related to physical and sport-specific activities. Safety and participant experience during the intervention will be monitored through validated questionnaires assessing simulator sickness symptoms and user experience.
The primary hypothesis is that participation in the immersive virtual reality intervention will improve reaction time performance and cognitive processing speed compared with the control condition. This pilot study will provide preliminary evidence regarding the feasibility, safety, and potential effectiveness of immersive virtual reality interventions for enhancing perceptual-motor performance in adolescents.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pontevedra
-
Pontevedra, Pontevedra, Spain, 36003
- Club de Balonmano Teucro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 12 and 15 years of age
- Being a male handball player
- Having at least one year of handball experience
- Not participating in any other organized competitive sport.
Exclusion Criteria:
-.The exclusion criteria included diagnosed neurological disorders, fear or intolerance of using virtual reality headsets, and diagnosed musculoskeletal disorders or injuries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immersive Virtual Reality Eye-Hand Coordination Training
Participants assigned to the experimental arm received an immersive virtual reality (IVR)-based eye-hand coordination training program in addition to their regular handball training.
The program was delivered over an 8-week period and was designed to improve visuomotor performance, reaction time, cognitive processing, and tactical effectiveness.
Participants continued their usual club-based handball training throughout the study.
|
The intervention consisted of a structured eye-hand coordination training program delivered through immersive virtual reality using the Rezzil Player: MicroWall exergame and a Meta Quest 2 head-mounted display with handheld controllers.
Participants completed one familiarization session followed by 13 training sessions over 8 weeks (two sessions per week).
During each session, participants were required to identify and touch randomly appearing red visual targets as quickly as possible using the controllers.
Training difficulty was progressively increased by modifying the spatial configuration of the virtual panels (3×3, 60°, 180°, and 360°).
Each training trial lasted 1 minute, and performance was quantified according to the number of targets successfully reached and response speed.
|
|
Placebo Comparator: Usual Handball Training
Participants assigned to the control arm continued their regular handball training activities prescribed by their clubs throughout the 8-week study period.
No immersive virtual reality exposure or additional eye-hand coordination training was provided.
|
Participants continued their standard handball training routines under the supervision of their coaches according to normal club practice.
No specific experimental intervention, placebo treatment, or virtual reality-based training was administered during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Reaction Time
Time Frame: 8 weeks
|
Visual Reaction Time (milliseconds) Visual reaction time was assessed using the Fast Reflex smartphone application.
Participants were instructed to touch the screen as quickly as possible when it changed color from red to green.
Response times were automatically recorded by the application and expressed in milliseconds.
Three familiarization trials were completed before testing, and the subsequent three trials were recorded for analysis.
|
8 weeks
|
|
Auditory Reaction Time
Time Frame: 8 weeks
|
Auditory Reaction Time (milliseconds) Auditory reaction time was assessed using the Fast Reflex smartphone application.
Participants were instructed to touch the screen as quickly as possible upon hearing an auditory signal emitted by the device.
Response times were automatically recorded in milliseconds.
Following three familiarization trials, the next three trials were recorded and used for analysis.
|
8 weeks
|
|
Cognitive Processing Speed
Time Frame: 8 weeks
|
Cognitive Processing Speed (SDMT score) Cognitive processing speed was assessed using the Symbol Digit Modalities Test (SDMT).
Participants were required to match a series of symbols with their corresponding numbers as quickly and accurately as possible according to a predefined key.
The outcome measure was the total number of correct responses completed within 90 seconds.
The number of errors committed during task performance was also recorded.
|
8 weeks
|
|
Tactical Effectiveness Index
Time Frame: 8 weeks
|
Tactical Effectiveness Index (TEI; 0-100 points) Tactical effectiveness was assessed using a composite Tactical Effectiveness Index (TEI) derived from official competition statistics.
The index incorporated positive performance indicators (goals scored, shooting percentage, 7-m throws earned, ball recoveries, defensive blocks, saves, and save percentage) and negative performance indicators (7-m throws conceded, turnovers, 2-min suspensions, and disciplinary sanctions).
All variables were standardized using z-scores.
For negative indicators, z-scores were multiplied by -1 so that higher values consistently reflected greater tactical effectiveness.
Standardized scores were summed to obtain a raw score and subsequently transformed to a 0-100 scale using min-max normalization.
Higher scores indicate greater tactical effectiveness.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulator Sickness Questionnaire
Time Frame: 8 weeks
|
Simulator Sickness Questionnaire (SSQ score) The safety and tolerability of the immersive virtual reality intervention were evaluated using the Simulator Sickness Questionnaire (SSQ).
The questionnaire assesses symptoms associated with cybersickness, with higher scores indicating greater symptom severity.
|
8 weeks
|
|
Game Experience Questionnaire - Post-Game Module
Time Frame: 8 weeks
|
Game Experience Questionnaire - Post-Game Module (GEQ score 0-100) Participants' subjective experience with the virtual reality system was evaluated using the Game Experience Questionnaire - Post-Game Module (GEQ).
This instrument assesses dimensions related to the user experience following interaction with the virtual reality environment.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-220126-14
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.
Clinical Trials on Reaction Time and Immersive Virtual Reality
-
Université Catholique de LouvainCompletedImmersive Virtual RealityBelgium
-
Chang Gung Memorial HospitalRecruitingFully Immersive Virtual RealityTaiwan
-
Cairo UniversityCompletedVirtual Reality | Pediatric Burn | Immersive Virtual Reality | Passive Virtual RealityEgypt
-
University of VigoThe Association of Relatives of Alzheimer's Patients and Other Dementias...CompletedDementia | Virtual Reality | Reaction Time | Virtual Reality Cognitive Training | Alzheimer s DiseaseSpain
-
Rigshospitalet, DenmarkRecruitingPediatric Emergency Medicine | Virtual Reality Simulation | Simulation-based Medical Education | Immersive Virtual Reality | DebriefingDenmark
-
Istanbul University - CerrahpasaCompletedStress | Performance | Nurse | Intensive Care (ICU) | Immersive Virtual RealityTurkey
-
Abant Izzet Baysal UniversityRecruitingParkinson Disease | Virtual Reality | Immersive Virtual Reality | Action Obervation Training | 3d RecordingTurkey (Türkiye)
-
Suzan AydınRecruitingStroke | Cognitive Dysfunction | Virtual Reality | Motor Impairment | Subacute Stroke | Immersive Virtual RealityTurkey
-
Instituto de Investigación Sanitaria AragónUniversidad de Zaragoza; Universidad San JorgeActive, not recruitingPhysical Therapy | Parkinson Disease (PD) | Immersive Virtual RealitySpain
-
Centre Hospitalier Universitaire, AmiensRecruitingDelirium | Intensive Care Unit | Discomfort | Immersive Virtual Reality | IPREAFrance
Clinical Trials on Immersive Virtual Reality Eye-Hand Coordination Training
-
Cliniques universitaires Saint-Luc- Université...Université Catholique de LouvainNot yet recruitingVirtual Reality | Brain | EEG | Manual Dexterity | fNIRSBelgium
-
I.R.C.C.S. Fondazione Santa LuciaRecruitingStroke | Neglect, HemispatialItaly
-
Acibadem UniversityKartal Dr. Lütfi Kirdar City HospitalCompletedRheumatoid Arthritis | Chronic Pain | Virtual RealityTurkey
-
Luzerner KantonsspitalRecruitingParkinson DiseaseSwitzerland
-
Foundation University IslamabadRecruitingElderly | Gait | Virtual Reality | BalancePakistan
-
Cairo UniversityRecruiting
-
European University Miguel de CervantesNot yet recruitingFrailty | Aging | Functional ImpairmentSpain
-
Recep Tayyip Erdogan UniversityThe Scientific and Technological Research Council of TurkeyCompletedAthletic PerformanceTurkey (Türkiye)
-
Groupe Hospitalier Paris Saint JosephActive, not recruitingChronic Low-back PainFrance