Cerebral PalsyNCT07078279
Effects of Virtual Reality on Functional Balance in Children With Cerebral Palsy (GMFCS III-IV)
A study testing immersive virtual reality intervention with Meta Quest 3 and Intervention with Conventional Balance Physical Therapy in people with Cerebral Palsy and Functional Balance, run by Bartolome Puerta Arroyo.
Trial summary
This study proposes a randomized clinical trial to evaluate the effectiveness of an immersive virtual reality (VR)-based rehabilitation intervention on functional balance in children and adolescents (5-20 years) with cerebral palsy (CP), at GMFCS levels III-IV. Read more about this study
- Who is it for?
- Ages 5 to 20 years
- Conditions the study is for
- Cerebral Palsy, Functional Balance
- What is being tested?
- immersive virtual reality intervention with Meta Quest 3 and Intervention with Conventional Balance Physical Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Sep 2026
- 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 5 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: Children and adolescents between 5 and 20 years old.
- Diagnosis: Medically confirmed diagnosis of cerebral palsy.
- Functional level: Classified as GMFCS (Gross Motor Function Classification System) level III or IV.
- Cognitive ability: Ability to understand basic instructions and participate in interactive activities.
- Medical stability: No uncontrolled seizures in the past 6 months, No recent orthopedic surgeries in the past 6 months, No botulinum toxin administration in the past 3 months, No serious cardiac or respiratory problems that would prevent light exercise.
- Informed consent: Signature of informed consent by a parent or legal guardian.
- Assent of the minor (if applicable): Verbal or written assent from the participant when age or developmentally appropriate.
Who cannot join
- Severe sensory impairments that interfere with virtual reality (VR): Profound visual impairment (blindness or severely reduced visual acuity that cannot be corrected), severe deafness without compensation through hearing aids (VR relies heavily on visual and auditory stimuli).
- Simultaneous participation in another intensive motor rehabilitation program during the 6-week study period to avoid confounding effects. Standard conventional therapy will be permitted.
- Extreme fear or intolerance to VR technology: If, after a brief initial session, the participant exhibits panic, severe dizziness, or other clear signs of discomfort, they will be excluded for safety and well-being reasons.
- New or uncontrolled medical instability: Any condition that may jeopardize patient safety during the intervention (e.g., acute infections, extreme pain, recent fractures).
About this study
Official title: Evaluation of a Rehabilitation Intervention Using Immersive Virtual Reality to Improve Functional Balance in Children and Adolescents With Cerebral Palsy (GMFCS III-IV)
This study proposes a randomized clinical trial to evaluate the effectiveness of an immersive virtual reality (VR)-based rehabilitation intervention on functional balance in children and adolescents (5-20 years) with cerebral palsy (CP), at GMFCS levels III-IV. The experimental group will receive VR therapy using Meta Quest 3 headsets over 6 weeks, compared to a control group receiving conventional balance physiotherapy during the same period. The primary objective is to determine whether VR therapy improves functional balance, assessed using the Early Clinical Assessment of Balance (ECAB). Secondary objectives include evaluating perceived quality of life (PedsQL) and treatment adherence over the 6-week intervention period.
Read the detailed description
Cerebral palsy (CP) is the most common cause of childhood motor disability, and at GMFCS levels III-IV it involves significant limitations in mobility and balance. Conventional physical therapies have achieved progress in this population but often rely on repetitive exercises that may become monotonous, affecting motivation and adherence among children and adolescents. In this context, immersive virtual reality emerges as an innovative rehabilitation tool, offering engaging and playful environments that increase patient motivation. Preliminary evidence suggests that VR provides a safe and stimulating environment that can enhance balance and motor skills in children with CP, although some studies have not found significant differences compared to traditional therapy.
This controlled randomized clinical trial follows international quality standards (CONSORT/SPIRIT guidelines) to ensure methodological rigor and transparency. A total of 40 participants with CP will be recruited and randomly assigned to either the VR intervention or the control group (20 per group). Therapy will be conducted over 6 weeks for both groups, with balance assessments performed by a physiotherapist blinded to the treatment allocation (i.e., unaware whether the participant belongs to the VR or control group). It is anticipated that the immersive VR intervention will significantly improve functional balance (ECAB score) more than conventional therapy. Additionally, improvements in perceived quality of life and high treatment adherence are expected in the VR group. If results confirm these hypotheses, this study would support the incorporation of immersive VR as an effective and safe complementary therapeutic approach in pediatric CP rehabilitation.
- Conditions
- Cerebral Palsy, Functional Balance
- Being tested
- immersive virtual reality intervention with Meta Quest 3, Intervention with Conventional Balance Physical Therapy
- Keywords
- Functional balance, Cerebral palsy, Immersive virtual reality, Pediatric, Early Clinical Assessment of Balance (ECAB)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive virtual reality intervention with Meta Quest 3Device
Also called virtual reality, meta quest 3, immersive virtual reality
The intervention consists of a rehabilitation program based on Immersive Virtual Reality (IVR), specifically designed to improve functional balance in children and adolescents with GMFCS levels III and IV cerebral palsy, between 5 and 20 years of age.
The Meta Quest 3 device will be used, a standalone, wireless, high-definition immersive virtual reality system. This device allows the user to fully immerse themselves in interactive virtual environments, blocking out external stimuli and offering an immersive, motivating, and controlled experience.
Intervention with Conventional Balance Physical TherapyOther
The Control Group (CG) will receive a standardized conventional physical therapy program focused on balance training, with the goal of improving postural and functional control in children and adolescents with GMFCS levels III and IV cerebral palsy, between 5 and 20 years of age.
This treatment is based on traditional exercises recognized within pediatric physical therapy for balance training and is designed to be comparable in time, frequency, and intensity to the experimental group (virtual reality), but without the use of immersive technology.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG): Intervention with Immersive Virtual Reality (VR) | Experimental | * Participants in the Experimental Group will receive a rehabilitation intervention focused on improving functional balance using immersive virtual reality (VR).
* The intervention will be delivered using Meta Quest 3 headsets, a stand-alone, wireless, high-definition device that allows for a fully immersive experience.
* Sessions will last 30 minutes, three times a week, for six weeks (total: 18 sessions).
* Activities within the virtual environment are designed to promote:
Postural control Static and dynamic balance Motor coordination
* The physical therapist will supervise each session and adapt the activities according to the participant's abilities and progress.
* Immediate feedback will be provided through the interactive elements of the virtual environment, which increases the child or adolescent's motivation and active participation. Receives: Device: immersive virtual reality intervention with Meta Quest 3 |
| Control Group (CG): Intervention with Conventional Balance Therapy | Active comparator | * Participants in the Control Group will receive a standardized conventional physical therapy program focused on balance training.
* This treatment is based on traditional exercises recognized within pediatric physical therapy to improve postural and functional control in children and adolescents with cerebral palsy.
* Sessions will also last 30 minutes, three times per week, for six weeks (total: 18 sessions), and will be taught by different pediatric physical therapists than those who treat the Experimental Group, to avoid cross-contamination between groups.
* Exercises will include:
Sitting and standing training Balance training on different surfaces Functional activities with manual support or technical aids
- The goal is to offer an effective therapeutic intervention comparable in time, frequency, and intensity to the Experimental Group, but without the use of VR technology. Receives: Other: Intervention with Conventional Balance Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Balance: ECAB Scale (Early Clinical Assessment of Balance)
This is a validated scale that assesses postural control in children and adolescents with cerebral palsy. It includes two components:
- Head and trunk control
- Balance in sitting and standing Total score: 0 to 100 points, with higher scores indicating better functional balance.
Assessment by: A physical therapist blinded to the assigned group (independent evaluator).
Measured: Week 0 (baseline) Week 7 (post-intervention) Week 13 (follow-up)
Secondary outcomes (1)
Perceived Quality of Life: PedsQL 4.0 Questionnaire (cerebral palsy-specific version, in Spanish)
Assesses the participant's subjective perception of their physical, emotional, social, and academic well-being.
Format: Self-administered by parents or the adolescent, if possible. Total score: Ranges from 0 (very low quality of life) to 100 (high quality of life)
Measured: Week 0 (baseline) Week 7 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartolome Puerta Arroyo
- Sponsor type
- University, hospital or other
- Collaborators
- Valero, Rocío Martín, Ph.D.
- Responsible party
- Sponsor-investigator, Bartolome Puerta Arroyo, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078279
- Sponsor's protocol ID
- 04072025
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rehabilitation Intervention Using Immersive Virtual Reality to Improve Functional Balance in Children and Adolescents With Cerebral Palsy (GMFCS III-IV)
- ClinicalTrials.gov ID
- NCT07078279
- Acronym / sponsor ID
- 04072025
- Conditions
- Cerebral Palsy, Functional Balance
- Keywords
- Functional balance, Cerebral palsy, Immersive virtual reality, Pediatric, Early Clinical Assessment of Balance (ECAB)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bartolome Puerta ArroyoUniversity, hospital or other
- Collaborators
- Valero, Rocío Martín, Ph.D.
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jul 2025 (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 study proposes a randomized clinical trial to evaluate the effectiveness of an immersive virtual reality (VR)-based rehabilitation intervention on functional balance in children and adolescents (5-20 years) with cerebral palsy (CP), at GMFCS levels III-IV. The experimental group will receive VR therapy using Meta Quest 3 headsets over 6 weeks, compared to a control group receiving conventional balance physiotherapy during the same period. The primary objective is to determine whether VR therapy improves functional balance, assessed using the Early Clinical Assessment of Balance (ECAB). Secondary objectives include evaluating perceived quality of life (PedsQL) and treatment adherence over the 6-week intervention period.
Detailed description
Cerebral palsy (CP) is the most common cause of childhood motor disability, and at GMFCS levels III-IV it involves significant limitations in mobility and balance. Conventional physical therapies have achieved progress in this population but often rely on repetitive exercises that may become monotonous, affecting motivation and adherence among children and adolescents. In this context, immersive virtual reality emerges as an innovative rehabilitation tool, offering engaging and playful environments that increase patient motivation. Preliminary evidence suggests that VR provides a safe and stimulating environment that can enhance balance and motor skills in children with CP, although some studies have not found significant differences compared to traditional therapy.
This controlled randomized clinical trial follows international quality standards (CONSORT/SPIRIT guidelines) to ensure methodological rigor and transparency. A total of 40 participants with CP will be recruited and randomly assigned to either the VR intervention or the control group (20 per group). Therapy will be conducted over 6 weeks for both groups, with balance assessments performed by a physiotherapist blinded to the treatment allocation (i.e., unaware whether the participant belongs to the VR or control group). It is anticipated that the immersive VR intervention will significantly improve functional balance (ECAB score) more than conventional therapy. Additionally, improvements in perceived quality of life and high treatment adherence are expected in the VR group. If results confirm these hypotheses, this study would support the incorporation of immersive VR as an effective and safe complementary therapeutic approach in pediatric CP rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicenter randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG): Intervention with Immersive Virtual Reality (VR) | Experimental | Device: immersive virtual reality intervention with Meta Quest 3* Participants in the Experimental Group will receive a rehabilitation intervention focused on improving functional balance using immersive virtual reality (VR). * The intervention will be delivered using Meta Quest 3 headsets, a stand-alone, wireless, high-definition device that allows for a fully immersive experience. * Sessions will last 30 minutes, three times a week, for six weeks (total: 18 sessions). * Activities within the virtual environment are designed to promote: Postural control Static and dynamic balance Motor coordination * The physical therapist will supervise each session and adapt the activities according to the participant's abilities and progress. * Immediate feedback will be provided through the interactive elements of the virtual environment, which increases the child or adolescent's motivation and active participation. |
| Control Group (CG): Intervention with Conventional Balance Therapy | Active comparator | Other: Intervention with Conventional Balance Physical Therapy* Participants in the Control Group will receive a standardized conventional physical therapy program focused on balance training. * This treatment is based on traditional exercises recognized within pediatric physical therapy to improve postural and functional control in children and adolescents with cerebral palsy. * Sessions will also last 30 minutes, three times per week, for six weeks (total: 18 sessions), and will be taught by different pediatric physical therapists than those who treat the Experimental Group, to avoid cross-contamination between groups. * Exercises will include: Sitting and standing training Balance training on different surfaces Functional activities with manual support or technical aids - The goal is to offer an effective therapeutic intervention comparable in time, frequency, and intensity to the Experimental Group, but without the use of VR technology. |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: Children and adolescents between 5 and 20 years old.
- Diagnosis: Medically confirmed diagnosis of cerebral palsy.
- Functional level: Classified as GMFCS (Gross Motor Function Classification System) level III or IV.
- Cognitive ability: Ability to understand basic instructions and participate in interactive activities.
- Medical stability: No uncontrolled seizures in the past 6 months, No recent orthopedic surgeries in the past 6 months, No botulinum toxin administration in the past 3 months, No serious cardiac or respiratory problems that would prevent light exercise.
Key exclusion criteria (4 listed)
- Severe sensory impairments that interfere with virtual reality (VR): Profound visual impairment (blindness or severely reduced visual acuity that cannot be corrected), severe deafness without compensation through hearing aids (VR relies heavily on visual and auditory stimuli).
- Simultaneous participation in another intensive motor rehabilitation program during the 6-week study period to avoid confounding effects. Standard conventional therapy will be permitted.
- Extreme fear or intolerance to VR technology: If, after a brief initial session, the participant exhibits panic, severe dizziness, or other clear signs of discomfort, they will be excluded for safety and well-being reasons.
- New or uncontrolled medical instability: Any condition that may jeopardize patient safety during the intervention (e.g., acute infections, extreme pain, recent fractures).
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 intervention with Meta Quest 3Also: virtual reality, meta quest 3, immersive virtual realityThe intervention consists of a rehabilitation program based on Immersive Virtual Reality (IVR), specifically designed to improve functional balance in children and adolescents with GMFCS levels III and IV cerebral palsy, between 5 and 20 years of age. The Meta Quest 3 device will be used, a standalone, wireless, high-definition immersive virtual reality system. This device allows the user to fully immerse themselves in interactive virtual environments, blocking out external stimuli and offering an immersive, motivating, and controlled experience. | Device | Experimental Group (EG): Intervention with Immersive Virtual Reality (VR) |
| Intervention with Conventional Balance Physical TherapyThe Control Group (CG) will receive a standardized conventional physical therapy program focused on balance training, with the goal of improving postural and functional control in children and adolescents with GMFCS levels III and IV cerebral palsy, between 5 and 20 years of age. This treatment is based on traditional exercises recognized within pediatric physical therapy for balance training and is designed to be comparable in time, frequency, and intensity to the experimental group (virtual reality), but without the use of immersive technology. | Other | Control Group (CG): Intervention with Conventional Balance Therapy |
Primary outcome
Functional Balance: ECAB Scale (Early Clinical Assessment of Balance)
Time frame: Week 0 (baseline) Week 7 (post-intervention) Week 13 (follow-up)
This is a validated scale that assesses postural control in children and adolescents with cerebral palsy. It includes two components: * Head and trunk control * Balance in sitting and standing Total score: 0 to 100 points, with higher scores indicating better functional balance. Assessment by: A physical therapist blinded to the assigned group (independent evaluator).
1 secondary outcome
Perceived Quality of Life: PedsQL 4.0 Questionnaire (cerebral palsy-specific version, in Spanish)
Time frame: Week 0 (baseline) Week 7 (post-intervention)
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 22 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing immersive virtual reality intervention with Meta Quest 3 and Intervention with Conventional Balance Physical Therapy in people with Cerebral Palsy and Functional Balance, run by Bartolome Puerta Arroyo.
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 7 inclusion and 4 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Balance: ECAB Scale (Early Clinical Assessment of Balance) (time frame: Week 0 (baseline) Week 7 (post-intervention) Week 13 (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2025.