Engineering and Technology
Ruimou Xie, MS
Mr.
Beijing Tsinghua Changgung Hospital, Tsinghua Medicine, Tsinghua University
Beijing, Beijing, China (People's Republic)
Jingyao Sun, PhD
Dr.
Department of Mechanical Engineering, Tsinghua University
Beijing, Beijing, China (People's Republic)
Yu Pan, MD
Director
Beijing Tsinghua Changgung Hospital
Beijing, Beijing, China (People's Republic)
Soft exoskeleton (SE) show promise for restoring ambulation after stroke, but evidence remains limited. This study evaluated the efficacy of bilateral SE-assisted gait training in subacute stroke.
Design:
In this single-blind randomized controlled trial, 60 individuals with subacute stroke were randomly assigned to either the bilateral SE group or the conventional training (CT) group. Both groups received 30-min conventional physical therapy per day for 20 days. Additionally, the SE group performed 30-min bilateral SE-assisted treadmill walking training once daily, while the CT group underwent unassisted treadmill walking training with the same frequency and duration. The primary outcome was the Functional Ambulation Category (FAC). Secondary outcomes were Fugl-Meyer Assessment for Lower Extremity (FMA-LE), Berg Balance Scale (BBS), spatiotemporal parameters, gait symmetry, and lower-limb kinematics.
Results:
After 20-session interventions, both groups showed significant within-group improvements in clinical scores, gait parameters and kinematics (p < 0.05). Between-group analysis showed that the SE group achieved significantly greater post-intervention scores in FAC, FMA-LE, BBS (all p < 0.05), and faster gait speed (p = 0.013) than the CT group. For Spatiotemporal analysis, the SE group demonstrated significantly longer paretic step length (p = 0.001) and shorter paretic swing time ( p = 0.014) than the CT group. In terms of gait symmetry, the SE group exhibited significantly lower temporal symmetry ratio (p < 0.001) and spatial symmetry ratio ( p < 0.001) than the CT group, indicating improved symmetry. Kinematic analysis revealed that the SE group achieved greater peak angles in paretic knee flexion ( p = 0.019) and paretic ankle dorsiflexion (p = 0.001) than the CT group. No serious adverse events were reported throughout the study.
Conclusion:
Bilateral SE-assisted gait training is a safe and effective approach to improving motor function and gait performance in patients with subacute stroke.