The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial

• Published in: Neurorehabilitation and neural repair Vol. 28; no. 7; p. 688
• Main Authors: Bethoux, Francois, Rogers, Helen L, Nolan, Karen J, Abrams, Gary M, Annaswamy, Thiru M, Brandstater, Murray, Browne, Barbara, Burnfield, Judith M, Feng, Wuwei, Freed, Mitchell J, Geis, Carolyn, Greenberg, Jason, Gudesblatt, Mark, Ikramuddin, Farha, Jayaraman, Arun, Kautz, Steven A, Lutsep, Helmi L, Madhavan, Sangeetha, Meilahn, Jill, Pease, William S, Rao, Noel, Seetharama, Subramani, Sethi, Pramod, Turk, Margaret A, Wallis, Roi Ann, Kufta, Conrad
• Format: Journal Article
• Language: English
• Published: United States 01.09.2014
• Subjects: Aged; Ankle - innervation; Ankle - physiopathology; Chronic Disease; Electric Stimulation Therapy; Female; Foot - innervation; Foot - physiopathology; Foot Orthoses; Gait Disorders, Neurologic - etiology; Gait Disorders, Neurologic - physiopathology; Gait Disorders, Neurologic - rehabilitation; Humans; Male; Middle Aged; Peroneal Nerve - physiopathology; Quality of Life; Recovery of Function; Stroke - complications; Stroke Rehabilitation; gait speed; stroke rehabilitation; functional electrical stimulation; quality of life; ankle-foot orthosis; foot drop
• ISSN: 1552-6844
• DOI: 10.1177/1545968314521007

Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle-foot orthoses (AFO) for treatment of foot drop poststroke, but few randomized controlled comparisons exist. To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. In a multicenter randomized controlled trial (ClinicalTrials.gov #NCT01087957) with unblinded outcome assessments, 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months. Primary endpoints: 10-Meter Walk Test (10MWT), a composite of the Mobility, Activities of Daily Living/Instrumental Activities of Daily Living, and Social Participation subscores on the Stroke Impact Scale (SIS), and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test, GaitRite Functional Ambulation Profile (FAP), Modified Emory Functional Ambulation Profile (mEFAP), Berg Balance Scale (BBS), Timed Up and Go, individual SIS domains, and Stroke-Specific Quality of Life measures. Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority. A total of 399 subjects completed the study. FES proved noninferior to the AFO for all primary endpoints. Both the FES and AFO groups improved significantly on the 10MWT. Within the FES group, significant improvements were found for SIS composite score, total mFEAP score, individual Floor and Obstacle course time scores of the mEFAP, FAP, and BBS, but again, no between-group differences were found. Use of FES is equivalent to the AFO. Further studies should examine whether FES enables better performance in tasks involving functional mobility, activities of daily living, and balance.