Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT01116466
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01116466
Study Brief:
Protocol Section:
NCT01116466