Discussion
stroke, fatigue, Exo-H2, pain
ADVERSE EVENTS, ADVERSE EFFECTS, STROKE
This article reports the results of a prospective, randomized, comparative clinical study, blinded to the evaluators conducted in a sample of individuals with incomplete SCI less than 1 year since injury to: (1) assess the safety and adherence to the robotic-assisted walking training as provided with of the device HANK exoskeleton by individuals with incomplete SCI; and (2) assess the changes in walking function after a training program with the robotic exoskeleton compared to traditional walking therapy. We hypothesized that the treatment with the exoskeleton would provide better functional walking outcomes than traditional overground gait therapy. To our knowledge, we present the first results of the effects on walking outcomes after training with robotic exoskeletons in SCI individuals less than 1 year since injury.Although we estimated 24 individuals per group, we managed to recruit 23 and analyze 21 subjects. However, we present the available data, and our interpretation is unlikely to introduce bias because we did not conduct any interim analysis [No serious adverse effects were found. Only a small number of skin issues were registered, and no participants withdrew from the study due to the use of the exoskeleton. All the clinical and functional variables assessed improved after treatment in both groups, although the WISCI-II improvement was greater in participants trained with the robotic exoskeleton. As it will be discussed below, this result has an important implication regarding the improvement mechanisms underlying the use of ambulatory robotic exoskeletons.The HANK exoskeleton introduces some improvements with respect to the preceding Exo-H2 exoskeleton, the latter proved its feasibility to provide walking assistance in a sample of stroke individuals with preserved walking ability [Here, we also demonstrate the feasibility of HANK to provide walking therapy in light of the changes in walking function in a sample of incomplete SCI individuals. The inclusion criteria focused on individuals with SCI less than 12 months since injury, not least because changes in the neurological situation can be expected and the effect of any therapy may be enhanced. In fact most of the patients were less than 6 months post injury. This supports the idea that the exoskeleton can be used to achieve better results in early gait rehabilitation. The optimal timing of treatment with exoskeletons, the duration and the protocols have yet to be defined. A recent study using an exoskeleton for gait training on acute SCI was yet focusing more on safety and feasibility than on neurological changes [All of the participants except 2 completed the 15 training sessions, and these two withdrawals were not related to the intervention. In terms of the feasibility and adverse events, our results were similar to other studies [The overall pain and fatigue perceived here were recorded during robotic gait training through a VAS scale [As in previous studies [