http://nnr.sagepub.com/content/28/7/688?etoc
- Francois Bethoux, MD1
- Helen L. Rogers, PhD2
- Karen J. Nolan, PhD3,4
- Gary M. Abrams, MD5
- Thiru M. 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, PT, 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
- Conrad Kufta, MD2
- 1Cleveland Clinic Foundation, Cleveland, OH, USA
- 2Innovative Neurotronics, Austin, TX, USA
- 3Kessler Foundation Research Center, West Orange, NJ, USA
- 4Rutgers–New Jersey Medical School, Newark, NJ, USA
- 5San Francisco VA Medical Center, San Francisco, CA, USA
- 6VA North Texas Health Care System, 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, 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, New York, NY, USA
- 15South Shore Neurologic Associates, Patchogue, NY, USA
- 16University of Minnesota Fairview, Minneapolis, MN
- 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, 1000 North Oak Avenue, Marshfield, WI, USA 54449
- 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 Medical Center, Los Angeles, CA, USA
- Francois Bethoux, The Cleveland Clinic Foundation, Desk U10, 9500 Euclid Avenue, 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 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.
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