Participants in the experimental phase received a progressive,
individualised FES cycling program performed four times a week for two weeks. The aim was to provide participants with 30 to 45 minutes of FES driven leg cycling within a one-hour session with the option of participants building up to this time from 20 minutes. However, all participants tolerated at least 30 minutes from the start. Three muscle groups were stimulated for each leg; quadriceps, hamstrings, and gluteals. Electrodes were placed over ZD6474 manufacturer two points on each muscle to provide a maximal contraction. One participant did not tolerate stimulation of the quadriceps; therefore the gastrocnemius was stimulated instead. FES cycling was performed using a leg FES cycling systema, with participants seated in their wheelchairs. A FES protocol based on that recommended by others (Krause Alectinib et al 2008) was used with the following parameters: frequency 33Hz, wavelength 350λ and stimulation amplitude of up to 140mA according to participants’ tolerance to ES. Resistance was set at the highest level that still enabled participants to cycle for at least 30 minutes. The initial sessions for each participant were supervised on a one-to-one basis by a physiotherapist with at least four years of experience in the management of spinal cord injury. Later sessions for participants
were sometimes supervised by a physiotherapist aide working under the guidance
of a physiotherapist. The usual care that was provided during both intervention phases of the study consisted of standard inpatient physiotherapy and occupational therapy that is typically provided to patients during their initial rehabilitation following spinal cord injury. This includes interventions directed at impairments below such as poor strength, restricted joint mobility, limited fitness, reduced dexterity, and pain. It also includes a strong focus on training of functional skills such as dressing, walking, transferring, using the hands, and pushing a wheelchair. All assessments were conducted at the beginning (baseline) and end of each two-week phase by trained assessors who were blinded to group allocation. The success of blinding was determined by asking assessors at the completion of each participant’s last assessment whether they had been unblinded. The primary outcome was urine output. Secondary outcomes were lower limb swelling measured as lower leg circumference, and spasticity measured using the Ashworth Scale and the Patient Reported Impact of Spasticity Measure (PRISM). An additional secondary outcome measure, Global Impression of Change, was collected at the completion of the trial. Baseline urine output was measured prior to the commencement of each trial phase with the participant sitting quietly and avoiding any activity.