title: The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: a randomized controlled trial.
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.
authors: Cleveland Clinic Foundation, Cleveland, OH, USA bethouf@ccf.org.
authors: Francois
authors: F
authors: Bethoux
authors: Innovative Neurotronics, Austin, TX, USA.
authors: Helen L
authors: HL
authors: Rogers
authors: Kessler Foundation Research Center, West Orange, NJ, USA Rutgers-New Jersey Medical School, Newark, NJ, USA.
authors: Karen J
authors: KJ
authors: Nolan
authors: San Francisco VA Medical Center, San Francisco, CA, USA.
authors: Gary M
authors: GM
authors: Abrams
authors: VA North Texas Health Care System, TX, USA UT Southwestern Medical Center, Dallas, TX, USA.
authors: Thiru M
authors: TM
authors: Annaswamy
authors: Loma Linda University Medical Center, Loma Linda, CA, USA.
authors: Murray
authors: M
authors: Brandstater
authors: Magee Rehabilitation Hospital, Philadelphia, PA, USA.
authors: Barbara
authors: B
authors: Browne
authors: Madonna Rehabilitation Hospital, Lincoln, NE, USA.
authors: Judith M
authors: JM
authors: Burnfield
authors: Medical University of South Carolina, Charleston, SC, USA.
authors: Wuwei
authors: W
authors: Feng
authors: Florida Hospital Neuroscience and Orthopedic Research Institute, Orlando, FL, USA.
authors: Mitchell J
authors: MJ
authors: Freed
authors: Halifax Health Center for Neurosciences, Daytona Beach, FL, USA.
authors: Carolyn
authors: C
authors: Geis
authors: Helen Hayes Hospital, West Haverstraw, New York, NY, USA.
authors: Jason
authors: J
authors: Greenberg
authors: South Shore Neurologic Associates, Patchogue, NY, USA.
authors: Mark
authors: M
authors: Gudesblatt
authors: University of Minnesota Fairview, Minneapolis, MN.
authors: Farha
authors: F
authors: Ikramuddin
authors: Rehabilitation Institute of Chicago, Chicago, IL, USA.
authors: Arun
authors: A
authors: Jayaraman
authors: Medical University of South Carolina, Charleston, SC, USA Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
authors: Steven A
authors: SA
authors: Kautz
authors: Oregon Health and Science University, Portland, OR, USA.
authors: Helmi L
authors: HL
authors: Lutsep
authors: University of Illinois at Chicago, Chicago, IL, USA.
authors: Sangeetha
authors: S
authors: Madhavan
authors: Marshfield Clinic Research Foundation, 1000 North Oak Avenue, Marshfield, WI, USA 54449.
authors: Jill
authors: J
authors: Meilahn
authors: The Ohio State University Wexner Medical Center, Columbus, OH, USA.
authors: William S
authors: WS
authors: Pease
authors: Marianjoy Rehabilitation Hospital, Wheaton, IL, USA.
authors: Noel
authors: N
authors: Rao
authors: Hartford Hospital, Hartford, CT, USA.
authors: Subramani
authors: S
authors: Seetharama
authors: Guilford Neurologic Associates, Greensboro, NC, USA.
authors: Pramod
authors: P
authors: Sethi
authors: SUNY Upstate Medical University, Syracuse, NY, USA.
authors: Margaret A
authors: MA
authors: Turk
authors: West Los Angeles VA Medical Center, Los Angeles, CA, USA.
authors: Roi Ann
authors: RA
authors: Wallis
authors: Innovative Neurotronics, Austin, TX, USA.
authors: Conrad
authors: C
authors: Kufta
mesh_terms: D000368:Aged; D000842:Ankle / Q000294:innervation / Q000503:physiopathology; D002908:Chronic Disease; D004599:Electric Stimulation Therapy; D005260:Female; D005528:Foot / Q000294:innervation / Q000503:physiopathology; D061826:Foot Orthoses; D020233:Gait Disorders, Neurologic / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010543:Peroneal Nerve / Q000503:physiopathology*; D011788:Quality of Life; D020127:Recovery of Function; D020521:Stroke / Q000150:complications; D000071939:Stroke Rehabilitation
keywords: ankle-foot orthosis; foot drop; functional electrical stimulation; gait speed; quality of life; stroke rehabilitation