title: 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.
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.
authors: Cleveland Clinic, 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, West Orange, NJ, USA Rutgers-New Jersey Medical School, Newark, NJ, USA.
authors: Karen J
authors: KJ
authors: Nolan
authors: UCSF/San Francisco VA Medical Center, San Francisco, CA, USA.
authors: Gary M
authors: GM
authors: Abrams
authors: VA North Texas Health Care System, Dallas, TX, USA UT Southwestern Medical Center, Dallas, TX, USA.
authors: Thiru
authors: T
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's Institute for Rehabilitation Science and Engineering, 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, 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, USA.
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, Marshfield, WI, USA.
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 Healthcare Center, Los Angeles, CA, USA David Geffen School of Medicine, UCLA, 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 / Q000503:physiopathology; D002908:Chronic Disease; D004599:Electric Stimulation Therapy / Q000379:methods*; D005260:Female; D061826:Foot Orthoses; D020233:Gait Disorders, Neurologic / Q000209:etiology* / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010543:Peroneal Nerve / Q000502:physiology*; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications*; D013997:Time Factors; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
keywords: ankle foot orthosis; foot drop; functional electrical stimulation; gait speed; quality of life; stroke rehabilitation