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Old 10-10-2012, 12:37 PM
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Default STUDY: WalkAide FES device improves gait function and quality of life

WalkAideŽ FES device improves gait function and quality of life for people with multiple sclerosis on Ampyra

L. Mayer, T. Warring, S. Agrella, E.J. Fox (Austin, US)

Background: Foot drop is prevalent in people with Multiple Sclerosis (MS). Foot drop, an inability to dorsiflex during swing, leads to abnormal gait, decreased speed, endurance and balance. Current accepted standards of care are pharmacologic, dalfampridine (Ampyra), or Orthotic, Ankle Foot Orthosis (AFO). Peroneal Nerve Functional Electrical Stimulation (FES), an alternative treatment, electrically stimulates the dorsiflexors resulting in active toe clearance and more natural gait. The purpose of this study was to determine the effect of the WalkAideŽ FES device (WA) on gait speed, endurance, gait quality, impact of MS on walking ability and Quality of Life (QOL) for people with MS on a stable dosage of Ampyra.

Methods: 20 subjects were recruited from a client list of people with MS and foot drop on a stable dose of Ampyra. Subjects completed the Timed 25 Foot Walk (T25FW), the 6 Minute Walk (6MWT), the Multiple Sclerosis Walking Scale 12 (MSWS 12) and the SF-36 at a screening visit without the WA. All measures were repeated with the WA at baseline, 1 and 3 month follow up visits. A Functional Ambulation Profile (FAP) was calculated at each visit using GaitRite system data.

Results: 16 subjects completed the study (7 male, 9 female). Mean age, duration of MS and time on Ampyra were 53.6, 16.5 and 2.0 years respectively. T25FW times decreased significantly between screening and 3 months (p=.028). 6MWT distances increased significantly between screening and 3 months (p=.019) and baseline and 1 month (p=.018). MSWS 12 scores decreased significantly between screening and baseline (p=.012), 1 (p=.002), and 3 months (p=.006) and between baseline and 1 month (p=.017). Improvements on the SF-36 subscales were significant between screening and baseline (p=.023), 1 (p=.002) and 3 months (p=.012) for Physical Function; screening and 3 months (p=.022) for Role Limitation Physical Health; screening and 1 month (p=.028) for Social Function; and screening and 1 month (p=.014) and baseline and 1 month (p=.008) for Vitality. FAP significantly improved between baseline and 1 month (p=.029).

Conclusions: Use of the WalkAideŽ significantly improves gait speed, endurance, QOL and gait quality and decreases the impact of MS on walking ability. Improvements, above and beyond benefits derived from an Ampyra regimen, suggest that the WalkAideŽ can augment pharmacological intervention and facilitate significant additional improvement in gait, function and QOL for people with MS.
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