Effects of Virtual Reality on Functional Balance in Children With Cerebral Palsy (GMFCS III-IV)

July 11, 2025 updated by: Bartolome Puerta Arroyo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group (EG): Intervention with Immersive Virtual Reality (VR)
  • 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.
Device: immersive virtual reality intervention with Meta Quest 3

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.

Other Names:
  • virtual reality
  • meta quest 3
  • immersive virtual reality
Active Comparator: Control Group (CG): Intervention with Conventional Balance 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.
Other: Intervention with Conventional Balance Physical Therapy

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 0 (baseline) Week 7 (post-intervention) Week 13 (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Quality of Life: PedsQL 4.0 Questionnaire (cerebral palsy-specific version, in Spanish)
Time Frame: Week 0 (baseline) Week 7 (post-intervention)

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)
Week 0 (baseline) Week 7 (post-intervention)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Adherence: Attendance and Compliance Record
Time Frame: Diary

It is measured as the percentage of sessions completed out of the total scheduled (18 total sessions: 3 sessions/week for 6 weeks).

Objective: To compare adherence between:

Experimental Group (virtual reality) Control Group (conventional therapy)
Diary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bartolome Puerta Arroyo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rocío Martín Valero

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04072025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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