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

NCT07078279 | Not Yet Recruiting

• 1 other identifier: 04072025
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy; Functional Balance

Keywords

Functional balance; Cerebral palsy; Immersive virtual reality; Pediatric; Early Clinical Assessment of Balance (ECAB)

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

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

Other Outcomes (1)

• Treatment Adherence: Attendance and Compliance Record

  Diary

Study Arms (2)

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.

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.

Other: Intervention with Conventional Balance Physical Therapy

Interventions

immersive virtual reality intervention with Meta Quest 3 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.

Also known as: virtual reality, meta quest 3, immersive virtual reality

Experimental Group (EG): Intervention with Immersive Virtual Reality (VR)

Intervention with Conventional Balance Physical Therapy 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.

Control Group (CG): Intervention with Conventional Balance Therapy

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bartolome Puerta Arroyo: lead
• Rocío Martín Valero: collaborator

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctorando Universidad Málaga

Model Details: Multicenter randomized clinical trial

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07