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  • Title: Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia.
    Author: Burridge JH, Haugland M, Larsen B, Pickering RM, Svaneborg N, Iversen HK, Christensen PB, Haase J, Brennum J, Sinkjaer T.
    Journal: J Rehabil Med; 2007 Apr; 39(3):212-8. PubMed ID: 17468789.
    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.
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