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

Author:

Bethoux Francois1,Rogers Helen L.2,Nolan Karen J.34,Abrams Gary M.5,Annaswamy Thiru67,Brandstater Murray8,Browne Barbara9,Burnfield Judith M.10,Feng Wuwei11,Freed Mitchell J.12,Geis Carolyn13,Greenberg Jason14,Gudesblatt Mark15,Ikramuddin Farha16,Jayaraman Arun17,Kautz Steven A.1118,Lutsep Helmi L.19,Madhavan Sangeetha20,Meilahn Jill21,Pease William S.22,Rao Noel23,Seetharama Subramani24,Sethi Pramod25,Turk Margaret A.26,Wallis Roi Ann2728,Kufta Conrad2

Affiliation:

1. Cleveland Clinic, Cleveland, OH, USA

2. Innovative Neurotronics, Austin, TX, USA

3. Kessler Foundation, West Orange, NJ, USA

4. Rutgers—New Jersey Medical School, Newark, NJ, USA

5. UCSF/San Francisco VA Medical Center, San Francisco, CA, USA

6. VA North Texas Health Care System, Dallas, TX, USA

7. UT Southwestern Medical Center, Dallas, TX, USA

8. Loma Linda University Medical Center, Loma Linda, CA, USA

9. Magee Rehabilitation Hospital, Philadelphia, PA, USA

10. Madonna Rehabilitation Hospital’s Institute for Rehabilitation Science and Engineering, Lincoln, NE, USA

11. Medical University of South Carolina, Charleston, SC, USA

12. Florida Hospital Neuroscience and Orthopedic Research Institute, Orlando, FL, USA

13. Halifax Health Center for Neurosciences, Daytona Beach, FL, USA

14. Helen Hayes Hospital, West Haverstraw, NY, USA

15. South Shore Neurologic Associates, Patchogue, NY, USA

16. University of Minnesota Fairview, Minneapolis, MN, USA

17. Rehabilitation Institute of Chicago, Chicago, IL, USA

18. Ralph H Johnson VA Medical Center, Charleston, SC, USA

19. Oregon Health and Science University, Portland, OR, USA

20. University of Illinois at Chicago, Chicago, IL, USA

21. Marshfield Clinic Research Foundation, Marshfield, WI, USA

22. The Ohio State University Wexner Medical Center, Columbus, OH, USA

23. Marianjoy Rehabilitation Hospital, Wheaton, IL, USA

24. Hartford Hospital, Hartford, CT, USA

25. Guilford Neurologic Associates, Greensboro, NC, USA

26. SUNY Upstate Medical University, Syracuse, NY, USA

27. West Los Angeles VA Healthcare Center, Los Angeles, CA, USA

28. David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

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.

Publisher

SAGE Publications

Subject

General Medicine

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