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Effects of a wearable exoskeleton stride management assist system (SMA) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial |
Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A |
Journal of NeuroEngineering & Rehabilitation 2015 Aug 20;12(69):Epub |
clinical trial |
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: 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 and D Corporation, Japan, with functional task specific training (FTST) on spatiotemporal gait parameters in stroke survivors. METHODS: 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 to 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. RESULTS: 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. CONCLUSIONS: 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 versus a clinic setting, and whether such home use provides continued benefits. TRIAL REGISTRATION: 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.
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