Who may benefit from robot-assisted gait training with an exoskeleton in subacute stroke patients? A prespecified analysis.

Abstract

To identify factors associated with the achievement of independent gait after the robot-assisted gait training (RAGT) with an exoskeletal wearable robot in subacute stroke patients. An international, multicentre, randomized, controlled trial. This prespecified analysis was performed on 58 and 69 subacute stroke patients in the RAGT and control groups. Each RAGT and the conventional gait training was provided 5 times per week for a period of 4 weeks. A Functional Ambulation Categories score of > 3 immediately post-intervention was defined as independent ambulation and clinical significance. Univariate and multivariate binary logistic regression models were used to determine possible predictors of clinically significant response to the RAGT and the conventional gait training. The 2 independent factors with the greatest impact on the response to RAGT for the achievement of independent gait were initial cognitive function and affected lower extremity power (p < 0.05). However, in the control group, stroke duration from onset to treatment and affected lower extremity power were significant independent factors (p < 0.05). This prespecified analysis suggests that the efficacy of RAGT with a wearable exoskeleton appears to be less dependent on time since onset within the early subacute phase, highlighting the importance of preserved cognitive function.