Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial

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Trials
, 17:477
First Online: 01 October 2016Received: 01 June 2016Accepted: 10 September 2016DOI: 10.1186-s13063-016-1604-x
Cite this article as: van Bloemendaal, M., Bus, S.A., de Boer, C.E. et al. Trials 2016 17: 477. doi:10.1186-s13063-016-1604-x
Abstract
BackgroundMany stroke survivors suffer from paresis of lower limb muscles, resulting in compensatory gait patterns characterised by asymmetries in spatial and temporal parameters and reduced walking capacity. Functional electrical stimulation has been used to improve walking capacity, but evidence is mostly limited to the orthotic effects of peroneal functional electrical stimulation in the chronic phase after stroke. The aim of this study is to investigate the therapeutic effects of up to 10 weeks of multi-channel functional electrical stimulation MFES-assisted gait training on the restoration of spatiotemporal gait symmetry and walking capacity in subacute stroke patients.
MethodsIn a proof-of-principle study with a randomised controlled design, 40 adult patients with walking deficits who are admitted for inpatient rehabilitation within 31 days since the onset of stroke are randomised to either MFES-assisted gait training or conventional gait training. Gait training is delivered in 30-minute sessions each workday for up to 10 weeks. The step length symmetry ratio is the primary outcome. Blinded assessors conduct outcome assessments at baseline, every 2 weeks during the intervention period, immediately post intervention and at 3-month follow-up.
DiscussionThis study aims to provide preliminary evidence for the feasibility and effectiveness of MFES-assisted gait rehabilitation early after stroke. Results will inform the design of a larger multi-centre trial.
Trial registrationThis trial is registered at the Netherlands Trial Register number NTR4762, registered 28 August 2014
KeywordsStroke Lower Limb Functional Electrical Stimulation Gait Training Spatiotemporal Parameters Abbreviations10MWT10-Meter Walk Test
AEsadverse events
FACFunctional Ambulation Categories
FESfunctional electrical stimulation
FES-IFalls Efficacy Scale I
FGAFunctional Gait Assessment
MASModified Ashworth Scale
MECMedical Ethics Committee
MFESmulti-channel functional electrical stimulation
PDApersonal digital assistant
PFESperoneal functional electrical stimulation
PROMpassive range of motion
SAEsserious adverse events
SGASspatiotemporal gait analysis system
Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1604-x contains supplementary material, which is available to authorized users.
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Autor: Maijke van Bloemendaal - Sicco A. Bus - Charlotte E. de Boer - Frans Nollet - Alexander C. H. Geurts - Anita Beelen
Fuente: https://link.springer.com/