Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
Jane Burridge, Morten Haugland, Birgit Larsen, Ruth M. Pickering, Niels Svaneborg, Helle K. Iversen, P. Brøgger Christensen, Jens Haase, Jannick Brennum and Thomas Sinkjaer
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.