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J Rehabil Med. 2007 Apr;39(3):212-8.

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

Author information

  • 1SOHPRS, University of Southampton, Highfield, UK. jhb1@soton.ac.uk

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.

PMID:
17468789
[PubMed - indexed for MEDLINE]
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