Effects of a wearable exoskeleton stride management assist system (SMA®) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial

Carolyn Buesing, Gabriela Fisch, Megan O’Donnell, Ida Shahidi, Lauren Thomas, Chaithanya K. Mummidisetty, Kenton J. Williams, Hideaki Takahashi, William Zev Rymer, Arun Jayaraman

Robots offer an alternative, potentially advantageous method of providing repetitive, high-dosage, and high-intensity training to address the gait impairments caused by stroke. In this study, we compared the effects of the Stride Management Assist (SMA®) System, a new wearable robotic device developed by Honda R&D Corporation, Japan, with functional task specific training (FTST) on spatiotemporal gait parameters in stroke survivors. A single blinded randomized control trial was performed to assess the effect of FTST and task-specific walking training with the SMA® device on spatiotemporal gait parameters. Participants (n = 50) were randomly assigned to FTST or SMA. Subjects in both groups received training 3 times per week for 6-8 weeks for a maximum of 18 training sessions. The GAITRite® system was used to collect data on subjects' spatiotemporal gait characteristics before training (baseline), at mid-training, post-training, and at a 3-month follow-up. After training, significant improvements in gait parameters were observed in both training groups compared to baseline, including an increase in velocity and cadence, a decrease in swing time on the impaired side, a decrease in double support time, an increase in stride length on impaired and non-impaired sides, and an increase in step length on impaired and non-impaired sides. No significant differences were observed between training groups; except for SMA group, step length on the impaired side increased significantly during self-selected walking speed trials and spatial asymmetry decreased significantly during fast-velocity walking trials. SMA and FTST interventions provided similar, significant improvements in spatiotemporal gait parameters; however, the SMA group showed additional improvements across more parameters at various time points. These results indicate that the SMA® device could be a useful therapeutic tool to improve spatiotemporal parameters and contribute to improved functional mobility in stroke survivors. Further research is needed to determine the feasibility of using this device in a home setting vs a clinic setting, and whether such home use provides continued benefits. This study is registered under the title "Development of walk assist device to improve community ambulation" and can be located in clinicaltrials.gov with the study identifier: NCT01994395 .