The Stride Management Assist (SMA®) device consist in a portable robotic exoskeleton designed for gait rehabilitation and training by repetition of walking patterns with automated regular gait cycles. Used for adult population with gait disorders of neurological or musculoskeletal origin that require rehabilitation. The objective of this work is to assess its efficacy and safety.

This technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of AETS-ISCIII. An early assessment of the technology was conducted. The searched databases were: Pubmed, Embase, WOS, Tripdatabase, ClinicalTrials.org and Cochrane Library. Clinical studies using the device published in any language until 10 October 2018 were reviewed.

We found 3 abstracts to congresses and 6 clinical trials that evaluated the use of the device. Outcomes measures among studies included spatiotemporal gait parameters, energy expenditure, muscular activity and functional performance. Five studies consisted in proof-of-concept analysis; 3 studies evaluated the effect of gait training with SMA® compared with conventional therapy alone in individuals after stroke (2 studies) and Parkinson disease (1 study); and 1 before-and-after study assessed the effect of gait training with SMA® in elderly adults. During its use, improvements in spatiotemporal gait parameters were described in 4/5 studies, and 2/5 studies showed less energy expenditure versus 2/5 studies that found no differences. After gait training, 3/4 studies described greater improvements in gait parameters when associated its use. Only one clinical trial collected safety data reporting no adverse events.

The SMA® device allows to increase the efficiency and parameters of the march during its use. The assistance in the stride might have an impact on health by facilitating the recovery of the gait; however, further research is needed to determine the feasibility in the latter case since comparative studies with conventional therapy are limited.