Effectiveness and safety of a lower-limb walking assist device for motor function recovery in subacute stroke patients: A prospective, randomized, open, parallel-controlled, noninferiority study.

ObjectiveTo evaluate the effectiveness and safety of the MI-R1 lower-limb walking assist device for gait training in subacute stroke patients.MethodsThe experimental group received lower-limb function training using the lower-limb training device. In contrast, the control group received lower-limb function training provided by a therapist. After 4 weeks, the patients were evaluated for certain indicators. The primary outcome was the Fugl-Meyer Assessment Lower Extremity score on day 28 (±7 days). The secondary outcomes included the Functional Ambulation Category score, Modified Barthel Index score, safety indicators, and incidence of adverse events.ResultsAfter treatment, the noninferiority statistic between the experimental and control groups was -0.1976 (-1.5051, 1.1099). The lower limit of the 95% confidence interval was greater than the noninferiority margin. There was no significant difference in the Functional Ambulation Category or Modified Barthel Index scores between the experimental and control groups at 0, 14, and 28 days (p > 0.05). There was no statistically significant difference in vital signs or adverse event rates between the experimental and control groups (p > 0.05).ConclusionsThe MI-R1 lower-limb walking assist device is not inferior to traditional rehabilitation in achieving lower-limb function recovery in subacute stroke patients and is associated with good patient safety.Trial registration: ClincialTrials, Unique identifier: NCT06564480 (retrospectively registered).