Global developmental delay (GDD) is a complex disorder that requires multimodal treatment involving different developmental skills. The objective of this single-blind, randomized, controlled pilot study is to evaluate the feasibility and effectiveness of conventional rehabilitation programs integrated with the BTs-Nirvana virtual reality system. Patients with GDD aged 12 to 66 months were enrolled and treated for a 48-session cycle. Patients were randomized into two groups, (1) conventional treatment and (2) conventional treatment supplemented with the use of BTs-Nirvana, in a 1:1 ratio. Before and after treatments, areas of global development were tested with the Griffiths-III Mental Developmental Scale and the clinical indicator of global improvement were measured with the Clinical Global Impressions-Improvement (CGI-I). Feasibility was confirmed by the high retention rate. The experimental group presented a significantly improvement in General Quotient (GQ) after treatment (GQ, p = 0.02), and the effect of the two treatments was significantly different in both the GQ (t =2.44; p = 0.02) and the Foundations of Learning subscale (t =3.66; p < 0.01). The overall improvement was also confirmed by the CGI-I (p = 0.03). According to these preliminary data, virtual reality can be considered a useful complementary tool to boost the effectiveness of conventional therapy in children with GDD.
Keywords: child; early intervention; educational; neurodevelopmental disorders; preschool; randomized controlled trial; virtual reality exposure therapy.