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

Jane Burridge, Morten Haugland, Birgit Tine Larsen, Ruth M. Pickering, Niels Svaneborg, Helle K. Iversen, P. Brøgger Christensen, Jens Haase, Jannick Brennum, Thomas Sinkjaer

Publikation: Bidrag til tidsskriftTidsskriftsartikelForskningpeer review

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.
OriginalsprogEngelsk
TidsskriftJournal of Rehabilitation Medicine
Vol/bind39
Udgave nummer3
Sider (fra-til)212-218
Antal sider7
ISSN1650-1977
DOI
StatusUdgivet - apr. 2007
Udgivet eksterntJa

Emneord

  • Electrical stimulation
  • Implanted electrodes
  • Rehabilitation
  • Stroke and gait

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