The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- kinematic gait parameters
研究概览
简要总结
The aim of this study is to investigate the effects of the implantable drop foot stimulator "ActiGait" (Ottobock Health Care, Duderstadt, Germany) on gait in hemiparetic patients. While several studies investigated the effects of implanted systems on walking speed and gait endurance, only a few studies have focused on the system's impact on kinematics and long-term outcomes. Therefore, our aim was to further investigate the effects of the implanted system ActiGait on gait kinematics and spatiotemporal parameters with a 1-year follow-up period.
详细描述
Patients with a neurologic condition leading to drop foot during swing phase in gait are treated by the implentation of the AcitGait system (which has a CE-certificate in Europe).
The aim of this study is to investigate the effect of the device on gait with a follow-up period of one year. Patients are assessed before implantation and at one-year follow up. At baseline, they are asked to walk without any assistive device, as well as with surface electrical stimulation of the peroneal nerve. At follow-up, they are asked to walk with the ActiGait system switched off and switched on.
Outcome assessments include a 10m-walking test and gait analysis with a VICON 3D-camera system. This allows to extract spatio-temporal parameters (as steps per minute, step length,...) as well as kinematic data (e.g. joint ankles during the gait cycle). All outcome data is analyzed using statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •drop foot after stroke, brain haemorrhage or multiple sclerosis
- •a minimum of six months after the acute infarction/onset of the disease
- •passive extension of the ankle to at least at neutral position
- •no sufficient active ankle extension
- •free walking without any aid for at least 20 meters in less than 2 minutes
- •a walking speed of ≤ 1,2m/sec (measured with 10 meter walking test)
- •use of surface electrical stimulation for at least three months
- •be able to stand freely
排除标准
- •damage to the peripheral nervous system
- •adiposity
- •substance abuse
- •no cognitive ability to follow the study instructions
- •pregnancy
- •use of other implanted devices
- •instable ankle joint or fixed contracture
研究组 & 干预措施
ActiGait
Patients who get the ActiGait implant
干预措施: ActiGait (Device)
结局指标
主要结局
kinematic gait parameters
时间窗: 1 year
Kinematic gait parameters are recorded and analysed using a 3D VICON infra-red camera system.
次要结局
- spatio-temporal parameters(1 year)
- Visual Analogue Scale for Health(1 year)
- 10-m-walking test(1 year)
研究者
Agnes Sturma
Physitherapist, Researcher
Medical University of Vienna