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

NCT ID: NCT07078279

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-09-30

Brief 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. 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.

Conditions

Cerebral Palsy; Functional Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

immersive virtual reality intervention with Meta Quest 3

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Intervention with Conventional Balance Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

virtual reality; meta quest 3; immersive virtual reality

Eligibility Criteria

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rocío Martín Valero

UNKNOWN

Sponsor Role: collaborator

Bartolome Puerta Arroyo

OTHER

Sponsor Role: lead

Responsible Party

Bartolome Puerta Arroyo

Doctorando Universidad Málaga

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

04072025

Identifier Type: -

Identifier Source: org_study_id