Implanted Drop Foot Stimulator for Hemiparetic Patients

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.

Inclusion criteria

• 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

Exclusion criteria

• damage to the peripheral nervous system
• epilepsy
• adiposity
• substance abuse
• no cognitive ability to follow the study instructions
• pregnancy
• use of other implanted devices
• instable ankle joint or fixed contracture