Safety, Acceptability, and Usability of Immersive Gamification System for Use in Rehabilitation Management of Pediatric Patients with Cerebral Palsy and with Mobility Limitations (Phase 1 Trial)

Virtual reality (VR) is increasingly integrated into the rehabilitation of children with cerebral palsy (CP). However, evidence to substantiate its potential as part of standard care remains limited. This Phase 1 study aimed to evaluate a VR-based immersive gamification technology system (ImGTS) for use in CP rehabilitation based on its safety, acceptability, and usability in healthy children. The system included software and hardware designs informed by discussions with CP rehabilitation and VR development experts (e.g., developmental pediatricians, physical therapists) and tailored to the local context, tested with two setups: the head-mounted display (HMD) and the semi-cave automatic virtual environment (semi-CAVE). We describe the experience of 30 healthy children aged 6–12 years using the ImGTS (Mission to Planet Axel version 1.0) using either the HMD (n = 15) or semi-CAVE (n = 15) setup. Descriptive and thematic analyses of data from semi-structured interviews based on questionnaires for safety and acceptability, as well as observations of behaviors for the usability dimensions of effectiveness, efficiency, and satisfaction, indicated that participants were engaged and motivated with the ImGTS, with low incidence and severity of VR-related symptoms for both setups and high acceptance of the ImGTS, based on perceptions of the environment and feelings of presence. Usability was also high. These findings suggest that the ImGTS is safe, acceptable, and usable for healthy children. This trial provides initial evidence to guide the methods of subsequent trials testing the safety, acceptability, usability, and clinical effectiveness of the ImGTS in children with cerebral palsy, and, eventually, to guide its deployment.