QUESTION: Does 4 weeks of active functional electrical stimulation (FES) cycling in addition to usual care improve mobility and strength more than usual care alone in people with a sub-acute acquired brain injury caused by stroke or trauma? DESIGN: Multi-centre, randomised, controlled trial. PARTICIPANTS: Forty patients from three Sydney hospitals with recently acquired brain injury and a mean composite strength score in the affected lower limb of 7 (SD 5) out of 20 points. INTERVENTION: Participants in the experimental group received an incremental, progressive, FES cycling program five times a week over a 4-week period. All participants received usual care. OUTCOME MEASURES: Outcome measures were taken at baseline and at 4 weeks. Primary outcomes were mobility and strength of the knee extensors of the affected lower limb. Mobility was measured with three mobility items of the Functional Independence Measure and strength was measured with a hand-held dynamometer. Secondary outcomes were strength of the knee extensors of the unaffected lower limb, strength of key muscles of the affected lower limb and spasticity of the affected plantar flexors. RESULTS: All but one participant completed the study. The mean between-group differences for mobility and strength of the knee extensors of the affected lower limb were -0.3/21 points (95% CI -3.2 to 2.7) and 7.5 Nm (95% CI -5.1 to 20.2), where positive values favoured the experimental group. The only secondary outcome that suggested a possible treatment effect was strength of key muscles of the affected lower limb, with a mean between-group difference of 3.0/20 points (95% CI 1.3 to 4.8). CONCLUSION: Functional electrical stimulation cycling does not improve mobility in people with acquired brain injury and its effects on strength are unclear.
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