Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
Phase II trial to evaluate the ActiGait implanted drop-foot stimulator in established hemiplegia
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DOI：
10.2340/16501977-0039
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发表时间：
2007-04-01
影响因子：
3.5
通讯作者：
Sinkjaer, Thomas
中科院分区：
文献类型：
--
作者：
Burridge, Jane;Haugland, Morten;Sinkjaer, Thomas
目的：评价选择性植入式落脚刺激器（acti步态）对行走的影响及安全性。设计：第11期试验，连续的参与者作为他们自己的对照。受试者：从丹麦的3个康复中心招募了在招募前至少6个月患有中风并有影响行走的下垂足的人。方法：对所有受试者植入刺激器。结果测量了刺激下踝关节背屈的范围、最大步行速度和4分钟步行距离。在植入前、90天和长期随访评估时进行测量。随时间变化，有无刺激均有报道。通过神经传导速度和不良事件评价安全性。结果：15名受试者植入，13名受试者完成试验。刺激后的步行速度和4分钟步行距离均有长期改善，刺激的矫形效果有统计学意义的改善。该装置不影响神经传导速度，也没有报道与该装置相关的严重不良事件。技术问题通过长期随访评估得到解决，观察到行走的进一步改善。结论：本试验评价了该装置的安全性和性能，患者接受度较高，不影响安全性。
Objective: To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety.Design: A phase 11 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.