Francois Bethoux1, Helen L Rogers2, Karen J Nolan3, Gary M Abrams4, Thiru Annaswamy5, Murray Brandstater6, Barbara Browne7, Judith M Burnfield8, Wuwei Feng9, Mitchell J Freed10, Carolyn Geis11, Jason Greenberg12, Mark Gudesblatt13, Farha Ikramuddin14, Arun Jayaraman15, Steven A Kautz16, Helmi L Lutsep17, Sangeetha Madhavan18, Jill Meilahn19, William S Pease20, Noel Rao21, Subramani Seetharama22, Pramod Sethi23, Margaret A Turk24, Roi Ann Wallis25, Conrad Kufta2. 1. Cleveland Clinic, Cleveland, OH, USA bethouf@ccf.org. 2. Innovative Neurotronics, Austin, TX, USA. 3. Kessler Foundation, West Orange, NJ, USA Rutgers-New Jersey Medical School, Newark, NJ, USA. 4. UCSF/San Francisco VA Medical Center, San Francisco, CA, USA. 5. VA North Texas Health Care System, Dallas, TX, USA UT Southwestern Medical Center, Dallas, TX, USA. 6. Loma Linda University Medical Center, Loma Linda, CA, USA. 7. Magee Rehabilitation Hospital, Philadelphia, PA, USA. 8. Madonna Rehabilitation Hospital's Institute for Rehabilitation Science and Engineering, Lincoln, NE, USA. 9. Medical University of South Carolina, Charleston, SC, USA. 10. Florida Hospital Neuroscience and Orthopedic Research Institute, Orlando, FL, USA. 11. Halifax Health Center for Neurosciences, Daytona Beach, FL, USA. 12. Helen Hayes Hospital, West Haverstraw, NY, USA. 13. South Shore Neurologic Associates, Patchogue, NY, USA. 14. University of Minnesota Fairview, Minneapolis, MN, USA. 15. Rehabilitation Institute of Chicago, Chicago, IL, USA. 16. Medical University of South Carolina, Charleston, SC, USA Ralph H Johnson VA Medical Center, Charleston, SC, USA. 17. Oregon Health and Science University, Portland, OR, USA. 18. University of Illinois at Chicago, Chicago, IL, USA. 19. Marshfield Clinic Research Foundation, Marshfield, WI, USA. 20. The Ohio State University Wexner Medical Center, Columbus, OH, USA. 21. Marianjoy Rehabilitation Hospital, Wheaton, IL, USA. 22. Hartford Hospital, Hartford, CT, USA. 23. Guilford Neurologic Associates, Greensboro, NC, USA. 24. SUNY Upstate Medical University, Syracuse, NY, USA. 25. West Los Angeles VA Healthcare Center, Los Angeles, CA, USA 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 mEFAPStair-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.
RCT Entities:
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.
Authors: D Yao; E Jakubowitz; S Ettinger; C Plaass; C Stukenborg-Colsman; K Daniilidis Journal: Oper Orthop Traumatol Date: 2017-05-04 Impact factor: 1.154
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