The Effects of Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in Patients With Chronic Stroke: A Randomized Controlled Trial

被引:78
作者
Bethoux, Francois [1 ]
Rogers, Helen L. [2 ]
Nolan, Karen J. [3 ,4 ]
Abrams, Gary M. [5 ]
Annaswamy, Thiru M. [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. [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 ]
Kufta, Conrad [2 ]
机构
[1] Cleveland Clin Fdn, Cleveland, OH 44195 USA
[2] Innovat Neurotron, Austin, TX USA
[3] Kessler Fdn, Res Ctr, W Orange, NJ USA
[4] Rutgers New Jersey Med Sch, Newark, NJ USA
[5] San Francisco VA Med Ctr, San Francisco, CA USA
[6] VA North Texas Hlth Care Syst, Dallas, TX USA
[7] UT Southwestern Med Ctr, Dallas, TX USA
[8] Loma Linda Univ, Med Ctr, Loma Linda, CA USA
[9] Magee Mem Rehabilitat Ctr, Philadelphia, PA USA
[10] Madonna Rehabil Hosp, 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, New York, 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 54449 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 Los Angeles VA Med Ctr, Los Angeles, CA USA
关键词
functional electrical stimulation; stroke rehabilitation; foot drop; gait speed; quality of life; ankle-foot orthosis; AMERICAN-HEART-ASSOCIATION; PERFORMANCE-MEASURES; WALKING PERFORMANCE; CHRONIC HEMIPARESIS; DROP STIMULATOR; GAIT; RELIABILITY; NEUROPROSTHESIS; SCALE; REHABILITATION;
D O I
10.1177/1545968314521007
中图分类号
R74 [神经病学与精神病学];
学科分类号
100204 [神经病学];
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 randomized controlled comparisons exist. Objective. To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. Methods. In a multicenter randomized controlled trial (ClinicalTrials.gov#NCT01087957) with unblinded outcome assessments, 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months. Primary endpoints: 10-Meter Walk Test (10MWT), a composite of the Mobility, Activities of Daily Living/Instrumental Activities of Daily Living, and Social Participation subscores on the Stroke Impact Scale (SIS), and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test, GaitRite Functional Ambulation Profile (FAP), Modified Emory Functional Ambulation Profile (mEFAP), Berg Balance Scale (BBS), Timed Up and Go, individual SIS domains, and Stroke-Specific Quality of Life measures. Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority. Results. A total of 399 subjects completed the study. FES proved noninferior to the AFO for all primary endpoints. Both the FES and AFO groups improved significantly on the 10MWT. Within the FES group, significant improvements were found for SIS composite score, total mFEAP score, individual Floor and Obstacle course time scores of the mEFAP, FAP, and BBS, but again, no between-group differences were found. Conclusions. Use of FES is equivalent to the AFO. Further studies should examine whether FES enables better performance in tasks involving functional mobility, activities of daily living, and balance.
引用
收藏
页码:688 / 697
页数:10
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