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

To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. A phase II trial in which a consecutive sample of participants acted as their own controls. 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. 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. 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. This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.