The Effects of Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in Patients With Chronic Stroke A Randomized Controlled Trial

With Walkaide and Bioness being equal to an AFO It seems highly unlikely our insurance will pay for the expensive stuff.
http://nnr.sagepub.com/content/28/7/688?etoc

1. Francois Bethoux, MD1
2. Helen L. Rogers, PhD2
3. Karen J. Nolan, PhD3,4
4. Gary M. Abrams, MD5
5. Thiru M. Annaswamy, MD, MA6,7
6. Murray Brandstater, MD, PhD8
7. Barbara Browne, MD9
8. Judith M. Burnfield, PhD10
9. Wuwei Feng, MD, MS11
10. Mitchell J. Freed, MD12
11. Carolyn Geis, MD13
12. Jason Greenberg, MD14
13. Mark Gudesblatt, MD15
14. Farha Ikramuddin, MD16
15. Arun Jayaraman, PT, PhD17
16. Steven A. Kautz, PhD11,18
17. Helmi L. Lutsep, MD19
18. Sangeetha Madhavan, PhD20
19. Jill Meilahn, DO21
20. William S. Pease, MD22
21. Noel Rao, MD23
22. Subramani Seetharama, MD24
23. Pramod Sethi, MD25
24. Margaret A. Turk, MD26
25. Roi Ann Wallis, MD27
26. Conrad Kufta, MD2

1. ¹Cleveland Clinic Foundation, Cleveland, OH, USA
2. ²Innovative Neurotronics, Austin, TX, USA
3. ³Kessler Foundation Research Center, West Orange, NJ, USA
4. ⁴Rutgers–New Jersey Medical School, Newark, NJ, USA
5. ⁵San Francisco VA Medical Center, San Francisco, CA, USA
6. ⁶VA North Texas Health Care System, TX, USA
7. ⁷UT Southwestern Medical Center, Dallas, TX, USA
8. ⁸Loma Linda University Medical Center, Loma Linda, CA, USA
9. ⁹Magee Rehabilitation Hospital, Philadelphia, PA, USA
10. ¹⁰Madonna Rehabilitation Hospital, Lincoln, NE, USA
11. ¹¹Medical University of South Carolina, Charleston, SC, USA
12. ¹²Florida Hospital Neuroscience and Orthopedic Research Institute, Orlando, FL, USA
13. ¹³Halifax Health Center for Neurosciences, Daytona Beach, FL, USA
14. ¹⁴Helen Hayes Hospital, West Haverstraw, New York, NY, USA
15. ¹⁵South Shore Neurologic Associates, Patchogue, NY, USA
16. ¹⁶University of Minnesota Fairview, Minneapolis, MN
17. ¹⁷Rehabilitation Institute of Chicago, Chicago, IL, USA
18. ¹⁸Ralph H. Johnson VA Medical Center, Charleston, SC, USA
19. ¹⁹Oregon Health and Science University, Portland, OR, USA
20. ²⁰University of Illinois at Chicago, Chicago, IL, USA
21. ²¹Marshfield Clinic Research Foundation, 1000 North Oak Avenue, Marshfield, WI, USA 54449
22. ²²The Ohio State University Wexner Medical Center, Columbus, OH, USA
23. ²³Marianjoy Rehabilitation Hospital, Wheaton, IL, USA
24. ²⁴Hartford Hospital, Hartford, CT, USA
25. ²⁵Guilford Neurologic Associates, Greensboro, NC, USA
26. ²⁶SUNY Upstate Medical University, Syracuse, NY, USA
27. ²⁷West Los Angeles VA Medical Center, Los Angeles, CA, USA

1. 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.