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

被引：49

作者：

Bethoux, Francois ^{[1
]}

Rogers, Helen L. ^{[2
]}

Nolan, Karen J. ^{[3
,4
]}

Abrams, Gary M. ^{[5
]}

Annaswamy, Thiru ^{[6
,7
]}

Brandstater, Murray ^{[8
]}

Browne, Barbara ^{[9
]}

Burnfield, Judith M. ^{[10
]}

Feng, Wuwei ^{[11
]}

Freed, Mitchell J. ^{[12
]}

Geis, Carolyn ^{[13
]}

Greenberg, Jason ^{[14
]}

Gudesblatt, Mark ^{[15
]}

Ikramuddin, Farha ^{[16
]}

Jayaraman, Arun ^{[17
]}

Kautz, Steven A. ^{[11
,18
]}

Lutsep, Helmi L. ^{[19
]}

Madhavan, Sangeetha ^{[20
]}

Meilahn, Jill ^{[21
]}

Pease, William S. ^{[22
]}

Rao, Noel ^{[23
]}

Seetharama, Subramani ^{[24
]}

Sethi, Pramod ^{[25
]}

Turk, Margaret A. ^{[26
]}

Wallis, Roi Ann ^{[27
,28
]}

Kufta, Conrad ^{[2
]}

机构：

[1] Cleveland Clin, Cleveland, OH 44106 USA

[2] Innovat Neurotron, Austin, TX USA

[3] Kessler Fdn, W Orange, NJ USA

[4] Rutgers New Jersey Med Sch, Newark, NJ USA

[5] Univ Calif San Francisco, San Francisco VA Med Ctr, San Francisco, CA 94143 USA

[6] VA North Texas Hlth Care Syst, Dallas, TX USA

[7] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA

[8] Loma Linda Univ, Med Ctr, Loma Linda, CA 92350 USA

[9] Magee Mem Rehabilitat Ctr, Philadelphia, PA USA

[10] Madonna Rehabil Hosp, Inst Rehabil Sci & Engn, Lincoln, NE USA

[11] Med Univ S Carolina, Charleston, SC 29425 USA

[12] Florida Hosp Neurosci & Orthoped Res Inst, Orlando, FL USA

[13] Halifax Hlth Ctr Neurosci, Daytona Beach, FL USA

[14] Helen Hayes Hosp, W Haverstraw, NY USA

[15] South Shore Neurol Associates, Patchogue, NY USA

[16] Univ Minnesota Fairview, Minneapolis, MN USA

[17] Rehabil Inst Chicago, Chicago, IL 60611 USA

[18] Ralph H Johnson VA Med Ctr, Charleston, SC USA

[19] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[20] Univ Illinois, Chicago, IL USA

[21] Marshfield Clin Res Fdn, Marshfield, WI USA

[22] Ohio State Univ, Wexner Med Ctr, Columbus, OH 43210 USA

[23] Marianjoy Rehabil Hosp, Wheaton, IL USA

[24] Hartford Hosp, Hartford, CT 06115 USA

[25] Guilford Neurol Associates, Greensboro, NC USA

[26] SUNY Upstate Med Univ, Syracuse, NY 13210 USA

[27] West Angeles VA Healthcare Ctr, Los Angeles, CA USA

[28] Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA

来源：

NEUROREHABILITATION AND NEURAL REPAIR | 2015年 / 29卷 / 10期

关键词：

functional electrical stimulation; ankle foot orthosis; stroke rehabilitation; gait speed; foot drop; quality of life; DROPPED FOOT; WALKING PERFORMANCE; GAIT; NEUROPROSTHESIS; SPEED; INDIVIDUALS; VELOCITY; HEMIPARESIS; RELIABILITY; PARAMETERS;

D O I：

10.1177/1545968315570325

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：911 / 922

页数：12

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