Evaluating the safety of a robotic supine gait training device for pediatric rehabilitation — a retrospective study

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Abstract
Purpose: This study aimed to test a robotic supine gait training (RSGT) device's safety when treating children and adolescents with a variety of diagnoses, to ensure their safety and the standardization of clinical practices. Methods: This retrospective observational study included 280 patients who underwent one or more treatment sessions with a RSGT device (DPA Med ® ) at the Nantes Regional Children's and Adolescent Health Care Center. These patients’ medical files, indexed in the digital medical file manager program, were examined in search of evidence of adverse events presumably associated with the treatment. The search also included when the adverse events took place, their severity, the required treatment, and the clinical outcomes. Results: From January 2, 2019, to June 1, 2021 (a 2.5-year period), no adverse events were logged, presumed, or definitively linked to the treatment, for any of the 280 patients included in this study (100% of the sample). Patients underwent an average of 5.71 (standard deviation = 7.06) treatment sessions, for a total of 1598 sessions during that period. Conclusion: No adverse events linked to RSGT were registered for the children and adolescents treated with the device in this preliminary study.

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