Domestic Use of the Exoskeleton for Gait Training in Patients with Spinal Cord Injuries: Ethical Dilemmas in Clinical Practice

In this paper, as in our previous works1 we evaluate some ethical questions about the domestic use of the robotic exoskeleton (ReWalk Robotics, Marlborough, MA, USA) (Esquenazi et al., 2012; Asselin et al., 2016) for gait assistance in people affected by a Spinal Cord Injury (SCI) (National spinal cord injury statistical center, 2010; Scivoletto et al., 2011). This device is presently FDA and EC market approved and it is now available in two different versions, one for hospital training and one for home-based use. The latter can be provided to the patient when a sufficient level of competence has been reached after special training. This work focuses on this second version of the ReWalk, since it was designed exclusively for domestic use. Ethical concerns may arise because financial coverage of the home ReWalk version is still under debate for most patients; it depends mainly on personal resources in so far as home delivery is not supported by common and shared International Provisional rules. In addition, in SCI patients the long term global consequences for health are marked by an increased risk of cardiovascular and metabolic diseases, while the paretic limbs may have a high risk of osteoporosis, skin lesions and deep venous thrombosis. Bowel constipation and pelvic floor impairment are other negative effects of SCI. Patents with SCI, their relatives, and their health care providers frequently classify the recovery of the ability to walk as a high priority, even where great effort has been made to alleviate the aforementioned consequences (American Spinal Cord Injury Association, 1982; Nene et al., 1996). To counteract these negative effects, Gait Retraining Programs have been operating for many years in order to exploit body-weight-supported gait on a treadmill (Sale et al., 2012), dynamic orthoses based upon passive mechanical hip-knee-ankle-foot orthoses (H-KAFO) which enable patients with SCI to ambulate over ground (Massucci et al., 1998) and/or similar synergic actions of Functional Electrical Stimulation (FES) with synchronized activation according to the different phases of the gait cycle (Nene and Patrick, 1990). Unfortunately, this type of treatment only results in obtaining a very slow gait speed with a high fatigue component.