BACKGROUND: We evaluated whether the Walkaide device could effectively improve walking ability and lower extremity function in post-stroke patients with foot drop. Patients aged 20 to 85 years with an initial stroke within <= 6 months and a functional ambulation classification score of 3 or 4 were eligible. MATERIALS AND METHODS: Patients were randomly allocated to the functional electrical stimulation (FES) or control group at a 1 to 1 ratio. A 40 min training program using Walkaide was additionally performed by the FES group five times per week for 8 weeks. The control group received the 40 min training program without FES. RESULTS: A total of 203 patients were allocated to the FES (n = 102) or control (n = 101) groups. Patients who did not receive the intervention or whose data were unavailable were excluded. Finally, the primary outcome data of 184 patients (n = 92 in each group) were analyzed. The mean change in the maximum distance during the 6-MWT (primary outcome) was 68.37 +/- 62.42 m and 57.50 +/- 68.17 m in the FES and control groups (difference 10.86 m; 95% confidence interval -8.26 to 29.98, p = 0.26), respectively. CONCLUSIONS: In Japanese post-stroke patients with foot drop, FES did not significantly improve the 6 min walk distance during the convalescent phase. The trial was registered at UMIN000020604.

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