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

Completed

Phase N/A Results

Eligibility Criteria

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).