Effectiveness of unilateral lower-limb exoskeleton robot on balance and gait recovery and neuroplasticity in patients with subacute stroke: a randomized controlled trial
Abstract
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. 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. 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,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 40 participants or records.
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