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

Francois Bethoux; Helen L Rogers; Karen J Nolan; Gary M Abrams; Thiru Annaswamy; Murray Brandstater; Barbara Browne; Judith M Burnfield; Wuwei Feng; Mitchell J Freed; Carolyn Geis; Jason Greenberg; Mark Gudesblatt; Farha Ikramuddin; Arun Jayaraman; Steven A Kautz; Helmi L Lutsep; Sangeetha Madhavan; Jill Meilahn; William S Pease; Noel Rao; Subramani Seetharama; Pramod Sethi; Margaret A Turk; Roi Ann Wallis; Conrad Kufta

doi:10.1177/1545968315570325

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

Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):911-22. doi: 10.1177/1545968315570325. Epub 2015 Feb 4.

Authors

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

Affiliations

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.

PMID: 25653225
DOI: 10.1177/1545968315570325

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.

Keywords: ankle foot orthosis; foot drop; functional electrical stimulation; gait speed; quality of life; stroke rehabilitation.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Ankle / physiopathology
Chronic Disease
Electric Stimulation Therapy / methods*
Female
Foot Orthoses
Gait Disorders, Neurologic / etiology*
Gait Disorders, Neurologic / therapy*
Humans
Longitudinal Studies
Male
Middle Aged
Peroneal Nerve / physiology*
Severity of Illness Index
Stroke / complications*
Time Factors
Treatment Outcome
Walking / physiology

Associated data

ClinicalTrials.gov/NCT01087957