Effect of a Foot-Drop Stimulator and Ankle-Foot Orthosis on Walking Performance After Stroke: A Multicenter Randomized Controlled Trial

1University of Alberta, Edmonton, Alberta, Canada.
Neurorehabilitation and neural repair (Impact Factor: 3.98). 04/2013; 27(7). DOI: 10.1177/1545968313481278
Source: PubMed


BACKGROUND: . Studies have demonstrated the efficacy of functional electrical stimulation in the management of foot drop after stroke. OBJECTIVE: . To compare changes in walking performance with the WalkAide (WA) foot-drop stimulator and a conventional ankle-foot orthosis (AFO). METHODS: . Individuals with stroke within the previous 12 months and residual foot drop were enrolled in a multicenter, randomized controlled, crossover trial. Subjects were assigned to 1 of 3 parallel arms for 12 weeks (6 weeks/device): arm 1 (WA-AFO), n = 38; arm 2 (AFO-WA), n = 31; arm 3 (AFO-AFO), n = 24. Primary outcomes were walking speed and Physiological Cost Index for the Figure-of-8 walking test. Secondary measures included 10-m walking speed and perceived safety during this test, general mobility, and device preference for arms 1 and 2 for continued use. Walking tests were performed with (On) and without a device (Off) at 0, 3, 6, 9, and 12 weeks. RESULTS: . Both WA and AFO had significant orthotic (On-Off difference), therapeutic (change over time when Off), and combined (change over time On vs baseline Off) effects on walking speed. An AFO also had a significant orthotic effect on Physiological Cost Index. The WA had a higher, but not significantly different therapeutic effect on speed than an AFO, whereas an AFO had a greater orthotic effect than the WA (significant at 12 weeks). Combined effects on speed after 6 weeks did not differ between devices. Users felt as safe with the WA as with an AFO, but significantly more users preferred the WA. CONCLUSIONS: . Both devices produce equivalent functional gains.

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    • "Three recent, large randomised controlled trials (Bethoux et al., 2014; Everaert et al., 2013; Kluding et al., 2013) have shown that surface-based peroneal FES is at least as effective as an AFO for improving walking velocity and various other aspects of balance and mobility in people with drop foot in the chronic phase of stroke. Moreover, several studies have shown that user satisfaction is consistently highest with FES (Bulley et al., 2011; Everaert et al., 2013; Kluding et al., 2013; van Swigchem et al., 2010). Typically, patients report that they are more satisfied with FES than with an AFO with regard to the effort and stability of walking, the quality of the gait pattern, walking distance, as well as comfort and appearance of the device (Kluding et al., 2013; van Swigchem et al., 2010). "
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    ABSTRACT: Purpose: To investigate whether an implantable functional electrical stimulation (FES) system of the common peroneal nerve (ActiGait®) improves relevant aspects of gait in chronic stroke patients with a drop foot typically using an ankle-foot orthosis (AFO). Methods: Ten community-dwelling patients participated, of whom eight patients could be analysed. Gait quality (kinematic, kinetic, and spatiotemporal characteristics) during a 10-meter comfortable walk test, normalised net energy expenditure during a 6-minute walk test, participation (physical activity and stroke impact) and user satisfaction were tested before implantation and at various moments after FES-system activation up to 26 weeks. Results: Walking with FES yielded increased maximum paretic ankle plantarflexion (FES: -0.12; AFO: -4.79°, p < 0.01), higher paretic peak ankle power (FES: 1.46; AFO: 0.98 W/kg, p < 0.05) and better step length symmetry (FES: 14.90; AFO: 21.45% , p < 0.05). User satisfaction was higher for FES, but was unrelated to objective gait improvements. Energy expenditure and participation did not change. Conclusion: Implantable FES improved the use of residual ankle plantarflexion motion, ankle power of the paretic leg and step length symmetry compared to using an AFO, however, not resulting in decreased energy expenditure or improved participation. User satisfaction was highest with FES, but this was not related to the observed gait improvements.
    Full-text · Article · Oct 2015
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    • "Previous research evaluating the immediate orthotic effect has shown only small changes in walking speed, improved dorsiflexion angle, and improved temporal–spatial characteristics (Knutson and Chae, 2010; Kottink et al., 2007; Sabut et al., 2010; Taylor et al., 1999a,b). These results demonstrate the efficacy for FDS utilization in poststroke rehabilitation but they fail to precisely indicate how FDS technology can improve gait mechanisms by helping to restore or maintain function (Everaert et al., 2013; Stein et al., 2010). "
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    ABSTRACT: Center of pressure measured during gait can provide information about underlying control mechanisms and the efficacy of a foot drop stimulator. This investigation evaluated changes in center of pressure displacement in individuals with stroke with and without a foot drop stimulator. Individuals with stroke-related foot drop (n=11) using a foot drop stimulator and healthy controls (n=11). Walking speed and bilateral center of pressure variables: 1) net displacement; 2) position and maximum displacement; and 3) mean velocity during walking. On the affected limb with the foot drop stimulator as compared to the affected limb without the foot drop stimulator: 1) increased anterior/posterior maximum center of pressure excursion 8% during stance; 2) center of pressure at initial contact was 6% more posterior; 3) medial/lateral mean, maximum and minimum center of pressure position during stance all significantly decreased; 4) anterior/posterior net displacement increased during stance and single support; and 5) anterior/posterior velocity of the center of pressure increased during stance. Individuals with stroke using a foot drop stimulator contacted the ground more posterior at initial contact and utilized more of the anterior/posterior plantar surface of the foot on the affected limb during stance. With the foot drop stimulator there was a shift in center of pressure toward the medial side possibly indicating an improvement in equinovarus gait where there is a tendency to load the lateral foot throughout stance. For individuals with stroke a foot drop stimulator can improve displacement of the center of pressure which indicates improved forward progression and stability during walking. Copyright © 2015 Elsevier Ltd. All rights reserved.
    Full-text · Article · Mar 2015 · Clinical biomechanics (Bristol, Avon)
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    • "Research investigating FES in individuals with acute and chronic hemiplegia and FD secondary to stroke indicate that this technology has the potential to restore physiological function and improve community ambulation (Robbins, Houghton, Woodbury, & Brown, 2006; Sabut, Sikdar, Mondal, Kumar, & Mahadevappa, 2010). These results demonstrate the efficacy for FDS utilization in post stroke rehabilitation but they fail to precisely indicate how FDS technology can restore motor function (Everaert et al., 2013; Kesar et al., 2010; Kesar et al., 2009, 2011; Kottink et al., 2004; Stein et al., 2006, 2010; Taylor et al., 1999). "
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    ABSTRACT: BACKGROUND: Functional Electrical Stimulation (FES) applied through a foot drop stimulator (FDS) is a rehabilitation intervention that can stimulate the common peroneal nerve to provide dorsiflexion at the correct timing during gait. OBJECTIVE: To determine if FES applied to the peroneal nerve during walking through a FDS would effectively retrain the electromyographic temporal activation of the tibialis anterior in individuals with stroke. METHODS: Surface electromyography (EMG) were collected bilaterally from the tibialis anterior (TA) while participants (n = 4) walked with and without the FDS at baseline and 4 weeks. Comparisons were made between stimulation timing and EMG activation timing to produce a burst duration similarity index (BDSI). RESULTS: At baseline, participants displayed variable temporal activation of the TA. At 4 weeks, TA activation during walking without the FDS more closely resembled the pre-programmed FDS timing demonstrated by an increase in BDSI scores in all participants (P = 0.05). CONCLUSIONS: Continuous use of FDS during a task specific movement can re-train the neuromuscular system. After 4 weeks of utilization the FDS trained the TA to replicate the programmed temporal activation patterns. These findings begin to establish the FDS as a rehabilitation intervention that may facilitate recovery rather than just compensate for stroke related gait impairments due to foot drop.
    Full-text · Article · Jul 2014 · Neurorehabilitation
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