Gait, Hemiplegic Clinical Trial
Official title:
The Long-term Effects of an Implantable Drop Foot Stimulator on Gait in Hemiparetic Patients
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.
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.
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