title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: The University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK. lisa.salisbury@ed.ac.uk
authors.forename: Lisa
authors.initials: L
authors.lastname: Salisbury
authors.forename: Jane
authors.initials: J
authors.lastname: Shiels
authors.forename: Iain
authors.initials: I
authors.lastname: Todd
authors.forename: Martin
authors.initials: M
authors.lastname: Dennis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D004599:Electric Stimulation Therapy; D005240:Feasibility Studies; D005260:Female; D005528:Foot; D020233:Gait Disorders, Neurologic / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D006429:Hemiplegia / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009989:Orthotic Devices; D010543:Peroneal Nerve; D020521:Stroke / Q000150:complications* / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome