A pilot study of randomized clinical controlled trial of gait training in subacute stroke patients with partial body-weight support electromechanical gait trainer and functional electrical stimulation: six-month follow-up.

Abstract

This study aimed to assess the effectiveness of gait training using an electromechanical gait trainer with or without functional electrical stimulation for people with subacute stroke. This was a nonblinded randomized controlled trial with a 6-month follow-up. Fifty-four subjects were recruited within 6 weeks after stroke onset and were randomly assigned to 1 of 3 gait intervention groups: conventional overground gait training treatment (CT, n=21), electromechanical gait trainer (GT, n=17) and, electromechanical gait trainer with functional electrical stimulation (GT-FES, n=16). All subjects were to undergo an assigned intervention program comprising a 20-minute session every weekday for 4 weeks. The outcome measures were Functional Independence Measure, Barthel Index, Motricity Index leg subscale, Elderly Mobility Scale (EMS), Berg Balance Scale, Functional Ambulatory Category (FAC), and 5-meter walking speed test. Assessments were made at baseline, at the end of the 4-week intervention program, and 6 months after the program ended. By intention-to-treat and multivariate analysis, statistically significant differences showed up in EMS (Wilks' lambda=0.743, P=0.005), FAC (Wilks' lambda=0.744, P=0.005) and gait speed (Wilks' lambda=0.658, P<0.0001). Post hoc analysis (univariate 2-way ANCOVA) revealed that the GT and GT-FES groups showed significantly better improvement in comparison with the CT group at the end of the 4 weeks of training and in the 6-month follow-up. For the early stage after stroke, this study indicated a higher effectiveness in poststroke gait training that used an electromechanical gait trainer compared with conventional overground gait training. The training effect was sustained through to the 6-month follow-up after the intervention.