The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke

A randomized controlled trial

Francois Bethoux, Helen L. Rogers, Karen J. Nolan, Gary M. Abrams, Thiru M. 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 Lutsep, Sangeetha Madhavan, Jill Meilahn, William S. Pease & 6 others Noel Rao, Subramani Seetharama, Pramod Sethi, Margaret A. Turk, Roi Ann Wallis, Conrad Kufta

Research output: Contribution to journalArticle

50 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)688-697
Number of pages10
JournalNeurorehabilitation and Neural Repair
Volume28
Issue number7
DOIs
StatePublished - 2014

Fingerprint

Foot Orthoses
Peroneal Nerve
Ankle
Electric Stimulation
Randomized Controlled Trials
Stroke
Activities of Daily Living
Walking
Foot
Quality of Life
Social Participation
Intention to Treat Analysis
Task Performance and Analysis
Medicare
Gait
Outcome Assessment (Health Care)
Equipment and Supplies

Keywords

  • ankle-foot orthosis
  • foot drop
  • functional electrical stimulation
  • gait speed
  • quality of life
  • stroke rehabilitation

ASJC Scopus subject areas

  • Clinical Neurology
  • Rehabilitation
  • Neurology
  • Medicine(all)

Cite this

The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke : A randomized controlled trial. / Bethoux, Francois; Rogers, Helen L.; Nolan, Karen J.; Abrams, Gary M.; Annaswamy, Thiru M.; Brandstater, Murray; Browne, Barbara; Burnfield, Judith M.; Feng, Wuwei; Freed, Mitchell J.; Geis, Carolyn; Greenberg, Jason; Gudesblatt, Mark; Ikramuddin, Farha; Jayaraman, Arun; Kautz, Steven A.; Lutsep, Helmi; Madhavan, Sangeetha; Meilahn, Jill; Pease, William S.; Rao, Noel; Seetharama, Subramani; Sethi, Pramod; Turk, Margaret A.; Wallis, Roi Ann; Kufta, Conrad.

In: Neurorehabilitation and Neural Repair, Vol. 28, No. 7, 2014, p. 688-697.

Research output: Contribution to journalArticle

Bethoux, F, Rogers, HL, Nolan, KJ, Abrams, GM, Annaswamy, TM, Brandstater, M, Browne, B, Burnfield, JM, Feng, W, Freed, MJ, Geis, C, Greenberg, J, Gudesblatt, M, Ikramuddin, F, Jayaraman, A, Kautz, SA, Lutsep, H, Madhavan, S, Meilahn, J, Pease, WS, Rao, N, Seetharama, S, Sethi, P, Turk, MA, Wallis, RA & Kufta, C 2014, 'The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke: A randomized controlled trial', Neurorehabilitation and Neural Repair, vol. 28, no. 7, pp. 688-697. https://doi.org/10.1177/1545968314521007
Bethoux, Francois ; Rogers, Helen L. ; Nolan, Karen J. ; Abrams, Gary M. ; Annaswamy, Thiru M. ; Brandstater, Murray ; Browne, Barbara ; Burnfield, Judith M. ; Feng, Wuwei ; Freed, Mitchell J. ; Geis, Carolyn ; Greenberg, Jason ; Gudesblatt, Mark ; Ikramuddin, Farha ; Jayaraman, Arun ; Kautz, Steven A. ; Lutsep, Helmi ; Madhavan, Sangeetha ; Meilahn, Jill ; Pease, William S. ; Rao, Noel ; Seetharama, Subramani ; Sethi, Pramod ; Turk, Margaret A. ; Wallis, Roi Ann ; Kufta, Conrad. / The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke : A randomized controlled trial. In: Neurorehabilitation and Neural Repair. 2014 ; Vol. 28, No. 7. pp. 688-697.
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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 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.",
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author = "Francois Bethoux and Rogers, {Helen L.} and Nolan, {Karen J.} and Abrams, {Gary M.} and Annaswamy, {Thiru M.} and Murray Brandstater and Barbara Browne and Burnfield, {Judith M.} and Wuwei Feng and Freed, {Mitchell J.} and Carolyn Geis and Jason Greenberg and Mark Gudesblatt and Farha Ikramuddin and Arun Jayaraman and Kautz, {Steven A.} and Helmi Lutsep and Sangeetha Madhavan and Jill Meilahn and Pease, {William S.} and Noel Rao and Subramani Seetharama and Pramod Sethi and Turk, {Margaret A.} and Wallis, {Roi Ann} and Conrad Kufta",
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T1 - The effects of peroneal nerve functional electrical stimulation versus ankle-foot orthosis in patients with chronic stroke

T2 - A randomized controlled trial

AU - Bethoux, Francois

AU - Rogers, Helen L.

AU - Nolan, Karen J.

AU - Abrams, Gary M.

AU - Annaswamy, Thiru M.

AU - Brandstater, Murray

AU - Browne, Barbara

AU - Burnfield, Judith M.

AU - Feng, Wuwei

AU - Freed, Mitchell J.

AU - Geis, Carolyn

AU - Greenberg, Jason

AU - Gudesblatt, Mark

AU - Ikramuddin, Farha

AU - Jayaraman, Arun

AU - Kautz, Steven A.

AU - Lutsep, Helmi

AU - Madhavan, Sangeetha

AU - Meilahn, Jill

AU - Pease, William S.

AU - Rao, Noel

AU - Seetharama, Subramani

AU - Sethi, Pramod

AU - Turk, Margaret A.

AU - Wallis, Roi Ann

AU - Kufta, Conrad

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

KW - ankle-foot orthosis

KW - foot drop

KW - functional electrical stimulation

KW - gait speed

KW - quality of life

KW - stroke rehabilitation

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