title: Functional electrical stimulation cycling has no clear effect on urine output, lower limb swelling, and spasticity in people with spinal cord injury: a randomised cross-over trial.
abstract: OBJECTIVE
  Does functional electrical stimulation (FES) cycling increase urine output and decrease lower limb swelling and spasticity in people with recent spinal cord injury?
  
  
  METHODS
  Randomised cross-over trial.
  
  
  METHODS
  Fourteen participants with a recent motor complete spinal cord injury were consecutively recruited from two spinal cord injury units in Sydney.
  
  
  METHODS
  Participants were randomised to an experimental phase followed by a control phase or vice versa, with a 1-week washout period in between. The experimental phase involved FES cycling four times a week for two weeks and the control phase involved standard rehabilitation for two weeks. Assessments by a blinded assessor occurred at the beginning and end of each phase. Allocation was concealed and an intention-to-treat analysis was performed.
  
  
  METHODS
  The primary outcome was urine output (mL/hr) and the secondary outcomes were lower limb circumference, and spasticity using the Ashworth Scale, and the Patient Reported Impact of Spasticity Measure (PRISM). In addition, participants were asked open-ended questions to explore their perceptions about treatment effectiveness.
  
  
  RESULTS
  All participants completed the study. The mean between-group difference (95% CI) for urine output was 82mL/hr (-35 to 199). The mean between-group differences (95% CI) for lower limb swelling, spasticity (Ashworth), and PRISM were -0.1cm (-1.5 to 1.2), -1.9 points (-4.9 to 1.2) and -5 points (-13 to 2), respectively. All point estimates of treatment effects favoured FES cycling. Participants reported many benefits from FES cycling.
  
  
  CONCLUSIONS
  There were no clear effects of FES cycling on urine output, swelling and spasticity even though all point estimates of treatment effects favoured FES cycling and participants perceived therapeutic effects.
  
  
  BACKGROUND
  ACTRN12611000923965.
authors.affiliation: Prince of Wales Spinal Injury Unit, Prince of Wales Hospital, Australia.
authors.forename: Keira E
authors.initials: KE
authors.lastname: Ralston
authors.forename: Lisa
authors.initials: L
authors.lastname: Harvey
authors.forename: Julia
authors.initials: J
authors.lastname: Batty
authors.forename: Lee B
authors.initials: LB
authors.lastname: Bonsan
authors.forename: Marsha
authors.initials: M
authors.lastname: Ben
authors.forename: Rita
authors.initials: R
authors.lastname: Cusmiani
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Bennett
mesh_terms: D000328:Adult; D001642:Bicycling; D002574:Cervical Vertebrae; D018592:Cross-Over Studies; D004487:Edema / Q000209:etiology / Q000534:rehabilitation*; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D035002:Lower Extremity; D008297:Male; D009128:Muscle Spasticity / Q000209:etiology / Q000534:rehabilitation*; D013119:Spinal Cord Injuries / Q000150:complications / Q000534:rehabilitation*; D013904:Thoracic Vertebrae; D016896:Treatment Outcome; D014555:Urination Disorders / Q000209:etiology / Q000534:rehabilitation*; D055815:Young Adult
keywords: Functional electrical stimulation cycling; Physical therapy; Spinal cord injury