Poster 52 Randomized Controlled Trial of Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in Chronic Stroke

To compare the effects of peroneal nerve functional electrical stimulation (FES) versus ankle-foot orthosis (AFO) on gait and quality of life (QoL) measures. Unblinded parallel group randomized controlled trial (RCT). The study was powered for a non-inferiority analysis of the primary and superiority analysis of the secondary endpoints. Multi-center RCT across 30 sites in the United States. Hemiparetic stroke survivors (≥ 6-months post stroke) with foot drop who met the inclusion/exclusion criteria. Subjects were randomized to a commercially available FES device (treatment group) or an AFO (control group) for all gait activity for 6 months. Gait velocity, a composite score consisting of the sum of the Mobility, ADL/IADL and Social Participation domain scores of the Stroke Impact Scale (SIS) and the device related Serious Adverse Events (SAEs) rate. Secondary endpoints included measures of walking performance, gait parameters, balance, and quality of life. 495 subjects were enrolled and 397 were used for analysis (completed baseline and 6-month assessments). Non-inferiority of FES compared to the AFO was established for all primary endpoints. For secondary endpoints the FES group significantly improved compared to the AFO group on four of the five components of the modified Emory Functional Ambulation Profile, the Berg Balance Scale, and the Strength and Mobility domain scores of the SIS. The peroneal nerve FES device was non-inferior to the AFO on measures of gait and balance, and may be more effective for improving functional ambulation and balance.