Feasibility and Preliminary Efficacy of Gait Training Assisted by Multichannel Functional Electrical Stimulation in Early Stroke Rehabilitation: A Pilot Randomized Controlled Trial.

Background. Many stroke survivors suffer from leg muscle paresis, resulting in asymmetrical gait patterns, negatively affecting balance control and energy cost. Interventions targeting asymmetry early after stroke may enhance recovery of walking. Objective. To determine the feasibility and preliminary efficacy of up to 10 weeks of gait training assisted by multichannel functional electrical stimulation (MFES gait training) applied to the peroneal nerve and knee flexor or extensor muscle on the recovery of gait symmetry and walking capacity in patients starting in the subacute phase after stroke. Methods. Forty inpatient participants (≤31 days after stroke) were randomized to MFES gait training (experimental group) or conventional gait training (control group). Gait training was delivered in 30-minute sessions each workday. Feasibility was determined by adherence (≥75% sessions) and satisfaction with gait training (score ≥7 out of 10). Primary outcome for efficacy was step length symmetry. Secondary outcomes included other spatiotemporal gait parameters and walking capacity (Functional Gait Assessment and 10-Meter Walk Test). Linear mixed models estimated treatment effect postintervention and at 3-month follow-up. Results. Thirty-seven participants completed the study protocol (19 experimental group participants). Feasibility was confirmed by good adherence (90% of the participants) and participant satisfaction (median score 8). Both groups improved on all outcomes over time. No significant group differences in recovery were found for any outcome. Conclusions. MFES gait training is feasible early after stroke, but MFES efficacy for improving step length symmetry, other spatiotemporal gait parameters, or walking capacity could not be demonstrated. Trial Registration. Netherlands Trial Register (NTR4762).

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

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: This trial is registered at the Netherlands Trial Register (number NTR4762 , registered 28 August 2014).