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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy; Functional Balance

• Registration Number: NCT07078279
• Lead Sponsor: Bartolome Puerta Arroyo

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2026-03-01
• Primary Completion: 2026-06
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Balance: ECAB Scale (Early Clinical Assessment of Balance)	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).

Secondary Outcome Measures

Name	Time	Method
Perceived Quality of Life: PedsQL 4.0 Questionnaire (cerebral palsy-specific version, in Spanish)	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)