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

Sponsor
Bartolome Puerta Arroyo
Study ID
NCT07078279
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy
  • Functional Balance

Eligibility Criteria

Sex
ALL
Age
5 Years - 20 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 22, 2025
Start date
Mar 31, 2026
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

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) ]

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