A feasibility study to investigate the clinical application of functional electrical stimulation (FES), for dropped foot, during the sub-acute phase of stroke - A randomized controlled trial.

PURPOSE Functional electrical stimulation (FES), for dropped foot, has been shown to have positive benefits in chronic stroke. It has been suggested that similar benefits may be seen earlier after stroke. The aim of this feasibility study was to evaluate the trial methodology of undertaking a randomized controlled trial (RCT) of FES in sub-acute stroke. METHOD This was a randomized feasibility study with non-blinded outcomes at 6 and 12 weeks. Sixteen sub-acute stroke in-patients with dropped foot were randomized into two groups (control, n =  7; intervention, n  =  9). Both groups received routine gait re-education and an orthotic device, the control group used an ankle foot orthosis and the intervention group used FES. Outcome measures included gait velocity and cadence, Functional Ambulation Classification, Visual Analogue Scale of perception of walking, and the Stroke Impact Scale. RESULTS Eligibility criteria developed for inclusion of participants in the trial were appropriate. Set-up of FES during sub-acute stroke was feasible but more challenging than with chronic patients. Outcome measures were suitable and have informed the choice of measures for future work. CONCLUSIONS It is feasible to undertake a trial evaluating FES during the sub-acute phase of recovery after stroke. A larger RCT is required.