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

Francois Bethoux, Helen L. Rogers, Karen J. Nolan, Gary M. Abrams, Thiru M. Annaswamy, Murray Brandstater, Barbara Browne, Judith M. Burnfield, Wuwei Feng, Mitchell J. Freed, Carolyn Geis, Jason Greenberg, Mark Gudesblatt, Farha Ikramuddin, Arun Jayaraman, Steven A. Kautz, Helmi L. Lutsep, Sangeetha Madhavan, Jill Meilahn, William S. PeaseNoel Rao, Subramani Seetharama, Pramod Sethi, Margaret A. Turk, Roi Ann Wallis, Conrad Kufta

Research output: Contribution to journalArticle

59 Scopus citations

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 randomized controlled comparisons exist. Objective. To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. Methods. 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. Results. 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. Conclusions. 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.

Original languageEnglish (US)
Pages (from-to)688-697
Number of pages10
JournalNeurorehabilitation and Neural Repair
Volume28
Issue number7
DOIs
StatePublished - Sep 2014

Keywords

  • ankle-foot orthosis
  • foot drop
  • functional electrical stimulation
  • gait speed
  • quality of life
  • stroke rehabilitation

ASJC Scopus subject areas

  • Rehabilitation
  • Neurology
  • Clinical Neurology

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    Bethoux, F., Rogers, H. L., Nolan, K. J., Abrams, G. M., Annaswamy, T. M., Brandstater, M., Browne, B., Burnfield, J. M., Feng, W., Freed, M. J., Geis, C., Greenberg, J., Gudesblatt, M., Ikramuddin, F., Jayaraman, A., Kautz, S. A., Lutsep, H. L., Madhavan, S., Meilahn, J., ... Kufta, C. (2014). The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: A randomized controlled trial. Neurorehabilitation and Neural Repair, 28(7), 688-697. https://doi.org/10.1177/1545968314521007