Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial.

Objective: To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions. Design: Multicentre, prospective, randomised, open-label trial. Setting: Twenty-three hospitals. Subjects: In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group. Intervention: Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device. Main measures: The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events. Results: Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient's subjective assessment (P = 0.048). Conclusion: The improvement in gait ability and body functions were equivalent with or without the use of the device. [ABSTRACT FROM AUTHOR]