Status:
COMPLETED
Implanted Drop Foot Stimulator for Hemiparetic Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Gait, Hemiplegic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 studie...
Detailed Description
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 stu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03447717
Start Date
July 26 2012
End Date
February 29 2016
Last Update
February 27 2018
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