Effects of Virtual Reality on Functional Balance in Children With Cerebral Palsy (GMFCS III-IV)
Launched by BARTOLOME PUERTA ARROYO · Jul 11, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using virtual reality (VR) technology can help improve balance in children and teenagers with cerebral palsy, specifically those who have moderate to severe movement difficulties (GMFCS levels III-IV). The study will compare two types of therapy over six weeks: one group will use VR headsets to do balance exercises, while the other group will receive traditional balance physiotherapy. Researchers want to see if VR therapy can make a difference in how well participants can balance, as well as how it affects their quality of life and how well they stick to the treatment.
Children and young people between 5 and 20 years old with a confirmed diagnosis of cerebral palsy and certain functional abilities are eligible to participate. Participants need to be able to follow simple instructions and be medically stable, meaning no recent surgeries, seizures, or serious health problems that would make exercise unsafe. Those with severe vision or hearing problems that would make using VR difficult, or who are afraid of the VR experience, may not be able to join. If accepted, participants will either use VR headsets for their therapy or receive regular balance exercises, with their progress being carefully monitored throughout the study. Parents or guardians will need to give permission, and older children will be asked if they agree to take part as well.
Gender
ALL
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).
About Bartolome Puerta Arroyo
Bartolome Puerta Arroyo is a clinical trial sponsor dedicated to advancing medical research through the support and oversight of innovative clinical studies. Committed to upholding the highest standards of scientific integrity and patient safety, the sponsor facilitates the development of new therapeutic interventions aimed at improving health outcomes. With a focus on collaboration and regulatory compliance, Bartolome Puerta Arroyo plays a vital role in bridging research and clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported