Using virtual reality for rehabilitation in children with developmental delays
Virtual Reality and Neuropsychiatric Rehabilitation: a Single-blind, Randomized, Controlled Pilot Study in Patients With Global Developmental Delay.
This study is testing if using a virtual reality program can help children with developmental delays improve their thinking and movement skills better than just standard treatment alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Months to 66 Months |
| Sex | All |
| Sponsor | IRCCS Centro Neurolesi Bonino Pulejo Academic / other |
| Locations | 1 site (Messina) |
| Trial ID | NCT05879952 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a virtual reality system called BTs Nirvana in rehabilitating children diagnosed with Global Developmental Delay (GDD). The research involves a single-blind, randomized, controlled design where participants receive either standard treatment plus BTs Nirvana sessions or standard treatment alone. The aim is to assess how well this innovative approach can stimulate cognitive and motor development in affected children. The study highlights the importance of early intervention in improving long-term outcomes for children with GDD.
Who should consider this trial
Good fit: Ideal candidates are children aged 12 to 66 months diagnosed with Global Developmental Delay without significant medical conditions.
Not a fit: Patients with significant medical conditions such as epilepsy or severe sensory deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive and motor development in children with Global Developmental Delay.
How similar studies have performed: Other studies have shown promise in using virtual reality for therapeutic interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with diagnosis of GDD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria; * age between 12 and 66 months; * patients without significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or other significant genetic disorders. * Signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process. Exclusion Criteria: * children not aged between 12 and 66 months; * significant medical conditions such as epilepsy, significant visual and auditory sensory deficits, traumatic brain injury, or significant genetic disorders. * Informed consent not signed of at least one family member to participate in the diagnostic/therapeutic process.
Where this trial is running
Messina
- IRCCS Neurolesi Bonino Pulejo — Messina, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Cucinotta, MD, PhD
- Email: francesca.cucinotta@irccsme.it
- Phone: 09060128256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.