Effects of soft robotic exoskeleton for gait training on clinical and biomechanical gait outcomes in patients with sub-acute stroke: a randomized controlled pilot study

BackgroundAnkle function impairment is a critical factor impairing normal walking in survivors of stroke. The soft robotic exoskeleton (SRE) is a novel, portable, lightweight assistive device with promising therapeutic potential for gait recovery during post-stroke rehabilitation. However, whether long-term SRE-assisted walking training influences walking function and gait quality in patients following subacute stroke is unknown. Therefore, the primary objective of this study was to assess the therapeutic effects of SRE-assisted walking training on clinical and biomechanical gait outcomes in the rehabilitation of patients with subacute stroke.MethodsA group patients who had experienced subacute stroke received conventional rehabilitation (CR) training combined with 10-session SRE-assisted overground walking training (30 min per session, 5 sessions/week, 2 weeks) (SRE group, n = 15) compared with the control group that received CR training only (CR group, n = 15). Clinical assessments and biomechanical gait quality measures were performed pre-and post-10-session intervention, with the 10-Minute Walk Test (10MWT) and 6-Minute Walk Test (6MWT) used to define the primary clinical outcome measures and the Functional Ambulation Category, Fugl-Meyer Assessment for Lower Extremity (FMA-LE) subscale, and Berg Balance Scale defined the secondary outcome measures. The gait quality outcome measures included spatiotemporal and symmetrical parameters during walking.ResultsAfter the 10-session intervention, the SRE and CR groups exhibited significant within-group improvements in all clinical outcome measures (p