Effectiveness of unilateral lower-limb exoskeleton robot on balance and gait recovery and neuroplasticity in patients with subacute stroke: a randomized controlled trial

Background Impaired balance and gait in stroke survivors are associated with decreased functional independence. This study aimed to evaluate the effectiveness of unilateral lower-limb exoskeleton robot-assisted overground gait training compared with conventional treatment and to explore the relationship between neuroplastic changes and motor function recovery in subacute stroke patients. Methods In this randomized, single-blind clinical trial, 40 patients with subacute stroke were recruited and randomly assigned to either a robot-assisted training (RT) group or a conventional training (CT) group. All outcome measures were assessed at the enrollment baseline (T0), 2nd week (T1) and 4th week (T2) of the treatment. The primary outcome was the between-group difference in the change in the Berg balance scale (BBS) score from baseline to T2. The secondary measures included longitudinal changes in the Fugl-Meyer assessment of the lower limb (FMA-LE), modified Barthel index (mBI), functional ambulation category (FAC), and locomotion assessment with gait analysis. In addition, the cortical activation pattern related to robot-assisted training was measured before and after intervention via functional near-infrared spectroscopy. Results A total of 30 patients with complete data were included in this study. Clinical outcomes improved after 4 weeks of training in both groups, with significantly better BBS (F = 6.341, p = 0.018, partial η2 = 0.185), FMA-LE (F = 5.979, p = 0.021, partial η2 = 0.176), FAC (F = 7.692, p = 0.010, partial η2 = 0.216), and mBI scores (F = 7.255, p = 0.042, partial η2 = 0.140) in the RT group than in the CT group. Both groups showed significant improvement in gait speed and stride cadence on the locomotion assessment. Only the RT group presented a significantly increased stride length (F = 4.913, p = 0.015, partial η2 = 0.267), support phase (F = 5.335, p = 0.011, partial η2 = 0.283), and toe-off angle (F = 3.829, p = 0.035, partial η2 = 0.228) on the affected side after the intervention. The RT group also showed increased neural activity response over the ipsilesional motor area and bilateral prefrontal cortex during robot-assisted weight-shift and gait training following 4 weeks of treatment. Conclusions Overground gait training with a unilateral exoskeleton robot showed improvements in balance and gait functions, resulting in better gait patterns and increased gait stability for stroke patients. The increased cortical response relate