Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

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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Author: Maijke van Bloemendaal - Sicco A. Bus - Charlotte E. de Boer - Frans Nollet - Alexander C. H. Geurts - Anita Beelen

Source: https://link.springer.com/

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