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

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. PeaseNoel Rao, Subramani Seetharama, Pramod Sethi, Margaret A. Turk, Roi Ann Wallis, Conrad Kufta

Research output: Contribution to journal › Article › peer-review

53 Scopus citations

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.

Original language	English (US)
Pages (from-to)	911-922
Number of pages	12
Journal	Neurorehabilitation and Neural Repair
Volume	29
Issue number	10
DOIs	https://doi.org/10.1177/1545968315570325
State	Published - Nov 1 2015
Externally published	Yes

Keywords

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

ASJC Scopus subject areas

Rehabilitation
Neurology
Clinical Neurology

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10.1177/1545968315570325

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Bethoux, F., Rogers, H. L., Nolan, K. J., Abrams, G. M., Annaswamy, T., Brandstater, M., Browne, B., Burnfield, J. M., Feng, W., Freed, M. J., Geis, C., Greenberg, J., Gudesblatt, M., Ikramuddin, F., Jayaraman, A., Kautz, S. A., Lutsep, H. L., Madhavan, S., Meilahn, J., ... Kufta, C. (2015). 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. Neurorehabilitation and Neural Repair, 29(10), 911-922. https://doi.org/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. / Bethoux, Francois; Rogers, Helen L.; Nolan, Karen J. et al.
In: Neurorehabilitation and Neural Repair, Vol. 29, No. 10, 01.11.2015, p. 911-922.

Research output: Contribution to journal › Article › peer-review

Bethoux, F, Rogers, HL, Nolan, KJ, Abrams, GM, Annaswamy, T, Brandstater, M, Browne, B, Burnfield, JM, Feng, W, Freed, MJ, Geis, C, Greenberg, J, Gudesblatt, M, Ikramuddin, F, Jayaraman, A, Kautz, SA, Lutsep, HL, Madhavan, S, Meilahn, J, Pease, WS, Rao, N, Seetharama, S, Sethi, P, Turk, MA, Wallis, RA & Kufta, C 2015, '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', Neurorehabilitation and Neural Repair, vol. 29, no. 10, pp. 911-922. https://doi.org/10.1177/1545968315570325

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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 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",

author = "Francois Bethoux and Rogers, {Helen L.} and Nolan, {Karen J.} and Abrams, {Gary M.} and Thiru Annaswamy 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 Lutsep, {Helmi L.} 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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doi = "10.1177/1545968315570325",

language = "English (US)",

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T1 - 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

AU - Bethoux, Francois

AU - Rogers, Helen L.

AU - Nolan, Karen J.

AU - Abrams, Gary M.

AU - Annaswamy, Thiru

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 L.

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 - 2015/11/1

Y1 - 2015/11/1

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 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.

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 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.

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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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

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