Research conducted at 30 rehabilitation centers across the United States compared changes in gait quality and function between functional electrical stimulation (FES) and AFOs in people with poststroke foot drop over a 12-month period. They study authors found that at 12 months, both users of both FES and AFOs continued to demonstrate equivalent gains in gait speed. According to the study’s authors, the results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation, however further research is needed to confirm those findings.
The study was a follow-up analysis of an unblended, randomized controlled trial at the rehabilitation centers that compared FES to AFOs over six months. The participants continued to wear their randomized devices for another six months, after which 12-month assessments were conducted. The subjects used the study devices for all home and community ambulation. A total of 495 subjects were randomized, and 384 completed the 12-month follow-up.
The primary endpoints, tested for noninferiority, were the ten-meter walk test (10MWT) and device-related serious adverse event rate. Secondary endpoints, tested for superiority, were the six-minute walk test (6MWT), the GaitRite Functional Ambulation Profile, and the modified Emory Functional Ambulation Profile (mEFAP).
The researchers concluded that FES proved noninferior to the AFO for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvements for the 10MWT compared with initial measurements. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for the 6MWT and mEFAP Stair-time subscore.
The study was published online before print February 4 in the journal Neurorehabilitation & Neural Repair.
