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

Question: Does functional electrical stimulation (FES) cycling increase urine output and decrease lower limb swelling and spasticity in people with recent spinal cord injury? Design: Randomised cross-over trial. Participants: Fourteen participants with a recent motor complete spinal cord injury were consecutively recruited from two spinal cord injury units in Sydney. Intervention: 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. Outcome measures: 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 82 mL/hr (-35 to 199). The mean between-group differences (95% CI) for lower limb swelling, spasticity (Ashworth), and PRISM were -0.1 cm (-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. Conclusion: 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. : ACTRN12611000923965.