Effect of Functional Electrical Stimulation in Convalescent Stroke Patients: A Multicenter, Randomized Controlled...

Area of Science:

• Rehabilitation Medicine
• Neuroscience
• Biomedical Engineering

Background:

• Foot drop is a common complication following stroke, impacting mobility and lower extremity function.
• The Walkaide device, utilizing functional electrical stimulation (FES), is a potential intervention for improving gait in post-stroke patients.
• Eligibility criteria included patients aged 20-85 with recent stroke (≤6 months) and specific ambulation scores (3 or 4).

Purpose of the Study:

• To evaluate the efficacy of the Walkaide device in enhancing walking ability and lower extremity function in post-stroke patients with foot drop.
• To compare the outcomes of functional electrical stimulation (FES) with conventional training in a post-stroke population.

Main Methods:

• A randomized controlled trial design was employed, allocating 203 patients 1:1 to either the FES group or a control group.
• The FES group received 40-minute training sessions with the Walkaide device five times weekly for 8 weeks.
• The control group underwent the same training duration and frequency but without FES.

Main Results:

• Primary outcome data from 184 patients (92 per group) were analyzed after exclusions.
• The mean change in the 6-minute walk test (6-MWT) distance showed a non-significant difference between groups (10.86 m; 95% CI: -8.26 to 29.98, p=0.26).
• The FES group achieved a mean improvement of 68.37 ± 62.42 m, while the control group improved by 57.50 ± 68.17 m.

Conclusions:

• Functional electrical stimulation (FES) with the Walkaide device did not yield statistically significant improvements in 6-minute walk distance for Japanese post-stroke patients during the convalescent phase.
• The findings suggest that FES may not be an effective standalone intervention for improving gait in this specific patient cohort.
• The study was registered under UMIN000020604.