A New Quality Assurance Standard for the Exploitation of the PHOENIX MK1 Exoskeleton

Exoskeletons, which are wearable devices that generate forces in one or more joints to support a physical activity, have already proven their benefits in neuromusculoskeletal disabilities. The primary objective of this study is to develop guidelines to provide information to future users of the Phoenix exoskeleton on safe use, maintenance, and good clinical practices with the ultimate goal of improving the user's quality of life. The study methodology consisted of analyzing the user manual provided by the manufacturer, followed by the completion of a number of 20 patient use sessions, of which 16 were active training sessions in which biological parameters were monitored (systolic blood pressure, diastolic blood pressure, degree of fatigue). The multimodal team was made up of: doctor, engineer/technician, physiotherapist, psychologist and patient. The test results allowed the development of the quality standard for the use of the PHOENIX MK1 exoskeleton, which are integrated into the family of standards developed by the manufacturer. We have concluded that it is possible to use the exoskeleton, under safe conditions, at the level of the C7 lesion, and the revision of the Phoenix MK1 exoskeleton is mandatory every 100 h, respectively 51 days.