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

This is going to be rather useless because of the expense of the BioNess or the WalkAide compared to a cheap AFO will likely never be approved by your insurance. But they don't seem to have tested for endpoints of walking without the device. That would be the best outcome.
http://nnr.sagepub.com/content/29/10/911?etoc

1. Francois Bethoux, MD1⇑
2. Helen L. Rogers, PhD2
3. Karen J. Nolan, PhD3,4
4. Gary M. Abrams, MD5
5. Thiru 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, 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, MD27,28
26. Conrad Kufta, MD2

1. ¹Cleveland Clinic, Cleveland, OH, USA
2. ²Innovative Neurotronics, Austin, TX, USA
3. ³Kessler Foundation, West Orange, NJ, USA
4. ⁴Rutgers—New Jersey Medical School, Newark, NJ, USA
5. ⁵UCSF/San Francisco VA Medical Center, San Francisco, CA, USA
6. ⁶VA North Texas Health Care System, Dallas, 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’s Institute for Rehabilitation Science and Engineering, 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, NY, USA
15. ¹⁵South Shore Neurologic Associates, Patchogue, NY, USA
16. ¹⁶University of Minnesota Fairview, Minneapolis, MN, USA
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, Marshfield, WI, USA
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 Healthcare Center, Los Angeles, CA, USA
28. ²⁸David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

1. 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.