Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke. (November 2015)

• Record Type: Journal Article
• Authors: Bethoux, Francois; Rogers, Helen L.; Nolan, Karen J.; Abrams, Gary M.; Annaswamy, Thiru; 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
• Is Part Of: Neurorehabilitation & neural repair. Volume 29:Number 10(2015)
• Page Start: 911
• Page End: 922
• Publication Date: 2015-11
• Subjects: functional electrical stimulation -- ankle foot orthosis -- stroke rehabilitation -- gait speed -- foot drop -- quality of life; Nervous system -- Diseases -- Patients -- Rehabilitation -- Periodicals; Brain damage -- Patients -- Rehabilitation -- Periodicals; Spinal cord -- Wounds and injuries -- Patients -- Rehabilitation -- Periodicals; Nervous system -- Regeneration -- Periodicals; Neuroplasticity -- Periodicals; 616.804305
• DOI: 10.1177/1545968315570325
• Languages: English
• ISSNs: 1545-9683

Abstract

Background . 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 long-term, randomized controlled comparisons exist. Objective . Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. Methods . Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). Results . A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. Conclusions . At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.