Functional electrical stimulation-assisted active cycling--therapeutic effects in patients with hemiparesis from 7 days to 6 months after stroke: a randomized controlled pilot study.

OBJECTIVE To determine whether functional electrical stimulation (FES)-assisted active cycling is more effective than active cycling without FES concerning walking and balance. Specifically, walking ability was classified as to the amount of personal assistance needed to be able to walk and balance was evaluated for static and dynamic balance tasks. DESIGN Monocentric, randomized, single-blinded, controlled trial. SETTING Neurologic rehabilitation hospital. PARTICIPANTS Patients with severe hemiparesis due to stroke (N=40). INTERVENTIONS Twenty minutes of active leg cycling with or without FES applied to the paretic vastus medialis and rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles, 3 times/wk for 4 weeks. MAIN OUTCOME MEASURES Functional ambulation classification (FAC) and performance-oriented mobility assessment (POMA) were the primary outcome measures. The leg subscale of the motricity index (MI) and the modified Ashworth scale were the secondary outcome measures. Evaluation was done before and after the intervention period and after an additional 2 weeks. RESULTS After the intervention, the FAC, POMA, and the MI (P<.016) for both intervention groups improved significantly. The FAC of the control group increased by a median of 1 category and that of the FES group by 2 categories. The median change in POMA was 2 and 4 points for the control group and the FES group, respectively. The Mann-Whitney U test between-group comparisons revealed that these gains were significantly better in the FES group for both the FAC (U=90; z=-2.58; P=.013; r=-.42) and the POMA (U=60; z=-3.43; P<.0004; r=-.56). Because of missing data and slightly decreased effect sizes during the follow-up phase (FAC, r=-.33; POMA, r=-.41), differences did not reach statistically significant P values. The MI leg subscale showed significant improvements in both groups. However, there were no significant differences between the groups at any time. No changes were observed on the modified Ashworth scale. CONCLUSIONS FES-assisted active cycling seems to be a promising intervention during rehabilitation in patients with stroke.