title: Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial.
abstract: Many 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.
  
  
  
  In 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.
  
  
  
  This 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.
  
  
  
  This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).
authors.affiliation: Merem Rehabilitation Centre De Trappenberg, Huizen, The Netherlands. mbloemendaal@trappenberg.merem.nl.|Department of Rehabilitation, Academic Medical Centre, Amsterdam, The Netherlands. mbloemendaal@trappenberg.merem.nl.
authors.forename: Maijke
authors.initials: M
authors.lastname: van Bloemendaal
authors.affiliation: Department of Rehabilitation, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Sicco A
authors.initials: SA
authors.lastname: Bus
authors.affiliation: Merem Rehabilitation Centre De Trappenberg, Huizen, The Netherlands.
authors.forename: Charlotte E
authors.initials: CE
authors.lastname: de Boer
authors.affiliation: Department of Rehabilitation, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Frans
authors.initials: F
authors.lastname: Nollet
authors.affiliation: Department of Rehabilitation, Donders Centre for Neuroscience, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Alexander C H
authors.initials: AC
authors.lastname: Geurts
authors.affiliation: Merem Rehabilitation Centre De Trappenberg, Huizen, The Netherlands.|Department of Rehabilitation, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: Anita
authors.initials: A
authors.lastname: Beelen
mesh_terms: D002985:Clinical Protocols; D004599:Electric Stimulation Therapy; D005684:Gait; D006801:Humans; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D011785:Quality Assurance, Health Care; D000071939:Stroke Rehabilitation / Q000379:methods*
keywords: Functional Electrical Stimulation; Gait; Lower Limb; Spatiotemporal Parameters; Stroke; Training