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 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. 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. TRIAL REGISTRATION ACTRN12611000923965.