http://nnr.sagepub.com/content/29/10/911?etoc
- Francois Bethoux, MD1⇑
- Helen L. Rogers, PhD2
- Karen J. Nolan, PhD3,4
- Gary M. Abrams, MD5
- Thiru Annaswamy, MD, MA6,7
- Murray Brandstater, MD, PhD8
- Barbara Browne, MD9
- Judith M. Burnfield, PhD10
- Wuwei Feng, MD, MS11
- Mitchell J. Freed, MD12
- Carolyn Geis, MD13
- Jason Greenberg, MD14
- Mark Gudesblatt, MD15
- Farha Ikramuddin, MD16
- Arun Jayaraman, PhD17
- Steven A. Kautz, PhD11,18
- Helmi L. Lutsep, MD19
- Sangeetha Madhavan, PhD20
- Jill Meilahn, DO21
- William S. Pease, MD22
- Noel Rao, MD23
- Subramani Seetharama, MD24
- Pramod Sethi, MD25
- Margaret A. Turk, MD26
- Roi Ann Wallis, MD27,28
- Conrad Kufta, MD2
- 1Cleveland Clinic, Cleveland, OH, USA
- 2Innovative Neurotronics, Austin, TX, USA
- 3Kessler Foundation, West Orange, NJ, USA
- 4Rutgers—New Jersey Medical School, Newark, NJ, USA
- 5UCSF/San Francisco VA Medical Center, San Francisco, CA, USA
- 6VA North Texas Health Care System, Dallas, TX, USA
- 7UT Southwestern Medical Center, Dallas, TX, USA
- 8Loma Linda University Medical Center, Loma Linda, CA, USA
- 9Magee Rehabilitation Hospital, Philadelphia, PA, USA
- 10Madonna Rehabilitation Hospital’s Institute for Rehabilitation Science and Engineering, Lincoln, NE, USA
- 11Medical University of South Carolina, Charleston, SC, USA
- 12Florida Hospital Neuroscience and Orthopedic Research Institute, Orlando, FL, USA
- 13Halifax Health Center for Neurosciences, Daytona Beach, FL, USA
- 14Helen Hayes Hospital, West Haverstraw, NY, USA
- 15South Shore Neurologic Associates, Patchogue, NY, USA
- 16University of Minnesota Fairview, Minneapolis, MN, USA
- 17Rehabilitation Institute of Chicago, Chicago, IL, USA
- 18Ralph H Johnson VA Medical Center, Charleston, SC, USA
- 19Oregon Health and Science University, Portland, OR, USA
- 20University of Illinois at Chicago, Chicago, IL, USA
- 21Marshfield Clinic Research Foundation, Marshfield, WI, USA
- 22The Ohio State University Wexner Medical Center, Columbus, OH, USA
- 23Marianjoy Rehabilitation Hospital, Wheaton, IL, USA
- 24Hartford Hospital, Hartford, CT, USA
- 25Guilford Neurologic Associates, Greensboro, NC, USA
- 26SUNY Upstate Medical University, Syracuse, NY, USA
- 27West Los Angeles VA Healthcare Center, Los Angeles, CA, USA
- 28David Geffen School of Medicine, UCLA, Los Angeles, CA, USA
- Francois Bethoux, The Cleveland Clinic Foundation, 9500 Euclid Ave, Desk U10, Cleveland, OH 44195, USA. Email: bethouf@ccf.org
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.
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