Clinical Study to Evaluate the Implantation of the ActiGait Drop Foot Stimulator System

Inclusion Criteria

• have a single sided hemiparesis persisting for more than 6 months due to a cerebro-vascular accident (CVA).
• be fully grown-up.
• have the ability to walk 20 meters in less than 2 minutes with or without walking aid but without the help of another person.
• have a reduced speed of walking.
• have the ability to stand upright with both heels touching the floor while hip and knee are in neutral position.
• have a passive range of movement of the affected ankle joint of at least 30 degrees.
• have a positive response to surface electrical stimulation of the peroneal nerve - i.e. muscle contraction which results in dorsiflexion of the ankle and improved gait.
• male or female older than 18 years of age.
• have signed written Informed consent to participate in the study.
• is willing and able to follow all study procedures including attendance at clinics for scheduled study visits.

Exclusion Criteria

• peripheral nerve damage of the affected leg.
• severe or uncontrolled diabetes with peripheral nerve involvement.
• poor skin condition on the affected leg.
• a thickness of subcutaneous fat exceeding 3.5 cm in the region of the implant.
• inability to walk 100 meters without stopping prior to CVA (with or without a walking aid, but without the help of another person).
• poorly controlled epilepsy.
• need of Ankle Foot Orthosis (AOF) to maintain ankle stability.
• concomitant medical and psychological conditions which would limit the success of the ActiGait® system such as: active degenerative diseases of the back and lower limbs, visuo-spatial neglect, or drug abuse, personality disorders or poor cognitive function.
• concomitant medical and psychological conditions which would compromise the safety of the patient in connection with the implantation and use of the ActiGait system, such as: severe cardiac disease, uncontrolled hypertension or history of malignancy within the preceding five years.
• other active implanted devices such as demand pacemakers or implanted defibrillators, as mutual electromagnetic interference may distort the efficacy of both systems and expose the patient to dangerous situations.
• history of falls greater than once a week.
• pregnancy and lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator.
• previous participation in this study
• participation in an investigational drug trial within 4 weeks prior to enrolment.
• requirement of an interpreter
• use of external FES system to assist walking four weeks prior to enrolment
• MRI of the affected thigh that is inconsistent with safe implantation of the ActiGait
• history of falls greater than once a week.
• pregnancy and lactation. Women of childbearing potential must maintain effective contraception during the study period, as judged by the investigator.
• previous participation in this study.
• participation in an investigational drug trial within 4 weeks prior to enrolment.
• requirement of an interpreter.
• anatomic situation of the common peroneal nerve identified by pre-surgical MRI that could compromise the success of ActiGait).