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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

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.
CI - (c) The Author(s) 2015.

Langue : ANGLAIS

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