Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia

Abstract

Objective: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. Design: A phase II trial in which a consecutive sample of participants acted as their own controls. Subjects: People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. Methods: Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events. Results: Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed. Conclusion: This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.

Human distal sciatic nerve fascicular anatomy: Implications for ankle control using nerve-cuff electrodes

“…O'Halloran et al made similar conclusions about generating pure dorsiflexion without inversion or eversion through balanced activation of two channels to the groups of fascicles he observed in the common fibular nerve [9]. Multicontact nerve-cuff electrodes implanted in humans are available and provide balanced dorsiflexion in foot-drop applications [7,[11][12][13], supporting the observed common fibular fascicular anatomy.…”

“…Implantable neural prostheses for foot drop generally use nerve-cuff electrodes to activate the motor nerves and lift the foot, and some record sensory information to trigger stimulation [1][2]4,[6][7][8][9][10][11][12][13]. However, most implantable neural prostheses provide only dorsiflexion to correct foot drop and do not provide active plantar flexion.…”

After Stroke Movement Impairments: A Review of Current Technologies for Rehabilitation

“…The prescription of an implantable peroneal nerve stimulator is only a treatment option when the main goal is to achieve an orthotic effect for the long term in drop foot patients [32]. Burridge et al [33] reported significant increases in mean gait distance and velocity (19%) using the ActiGait system. In a research conducted by Taylor et al [26] 46 drop foot patients were selected from ODFS system users that had skin irritation, difficulties with electrode placement or anticipated long-term use with the device.…”

Neuromuscular Electrical Stimulation for Motor Restoration in Hemiplegia

“…56 The other is a fourchannel device, developed at Aalborg University (Denmark) and utilizes a 4-channel nerve cuff electrode surgically placed around the common peroneal nerve. 57 Peroneal nerve stimulation (PNS) during gait has positive neuroprosthetic and therapeutic effects on ambulation. Neuroprosthetic effects have been shown in a number of case series studies and several RCTs, with outcome measures ranging from gait kinematic and spatiotemporal parameters to metabolic cost indices.…”