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

Abstract

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.

The Efficiency of Functional Electrical Stimulation and Balance-Weighted Rehabilitation Therapy in Stroke Patients with Foot-Drop: A Pilot Study

“…The increase when FES is used is greater than with the use of conventional therapy, although some studies have reported no difference. 12,14,16,[21][22][23][24] In the comparisons before and after treatment, a significant improvement in walking speed was observed as in the current study. In other FES efficacy studies, it has been reported that the effect on walking speed was significant and this effect continued for up to 1 year on average.…”

“…This increase in walking speed can be considered to be related to regular walking activity and exercises. [17][18][19][20][21][22][23][24] In the current study, VGA showed significant improvements in ankle rotations and initial contact of the foot between the baseline and 4-week measurements. In parallel with this, a significant synchronisation with the normal side of the stance was observed.…”

Spatiotemporal, Kinematic and Kinetic Assessment of the Effects of a Foot Drop Stimulator for Home-Based Rehabilitation of Patients with Chronic Stroke -- A Three-Dimensional Motion Analysis

“…Skin surface electrodes were placed at the proximal lateral condyles of the tibia to stimulate the peroneal nerve during the gait cycle. The frequency (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33), pulse width (100-300 µs) and intensity of the generated electrical pulse were customized to produce the desired dorsi exion during gait. The timing of tPNS activation and duration of stimulation were controlled by a tilt sensor and accelerometer according to the position and angle of the calf and speed of oscillation during the gait cycle.…”

“…This clinically accepted rehabilitation intervention has been demonstrated to be more e cient than AFO, especially in terms of improving walking speed [22,23]. However, a multicenter prospective randomized study found that the use of peroneal nerve FES was equivalent to device-free gait training in terms of the clinical outcomes of improvements in walking speed, the Fugl-Meyer Assessment of Lower Extremity (FMA-LE) score, ankle muscle strength and dorsi exion performance [24].…”

Spatiotemporal, kinematic and kinetic assessment of the effects of a foot drop stimulator for home-based rehabilitation of patients with chronic stroke: a randomized clinical trial

“…This clinically accepted rehabilitation intervention has been demonstrated to be more efficient than AFO, especially in terms of improving walking speed [ 22 , 23 ]. However, a multicenter prospective randomized study found that the use of peroneal nerve FES was equivalent to device-free gait training in terms of the clinical outcomes of improvements in walking speed, the Fugl–Meyer Assessment of Lower Extremity (FMA-LE) score, ankle muscle strength and dorsiflexion performance [ 24 ].…”