Explorer: Safety and Usability of a Gait Exoskeleton for Children with Motor Disabilities in Natural Environments.

OBJECTIVE: To evaluate the safety and usability of an exoskeleton designed for personal use in real-world settings in children with motor disability. DESIGN: Prospective, multicenter, open-label safety and usability study SETTING: Participants' homes and their usual community environments. PARTICIPANTS: Fifty children aged 2 to 17 years (25 boys, 25 girls) diagnosed with neurological or neuromuscular disease. INTERVENTION: Participants completed eight sessions using the Explorera personal exoskeleton in home and community settings guided by their caregivers and the researchers. MAIN OUTCOME MEASURES: Safety was assessed by monitoring adverse events, while usability outcomes included donning time, level of assistance required, user satisfaction (QUEST 2.0 questionnaire), and device usage data (usage time, number of steps, number of environments where the device was used). RESULTS: The device was used in 94% of planned sessions and no serious adverse events were recorded. Donning times averaged 4.7 ± 1.8 minutes, and satisfaction scores were high with median QUEST 2.0 scores of 4/5. The device was used equally in indoor (52.7%) and outdoor (47.3%) environments, including schools and playgrounds and the average time of use per session was 21.2 ± 15.1 minutes, while the average number of steps taken per session was 392.0 ± 244.0 steps. CONCLUSION: The study provides preliminary evidence that the pediatric exoskeleton is safe and usable in real‑world settings. Its use in the daily lives of children with motor disabilities may contribute to improved mobility and support participation in everyday activities, aligning with WHO recommendations for physical activity and the F-Words framework for child development.