Status:
COMPLETED
Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hysterical Simulation of Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking ...
Detailed Description
The implantable feet stimulator proposes to correct the feet's STEPPAGE observed after central nervous system's injury such as hemiplegia secondary to stroke. It aims to improve the patient's walking ...
Eligibility Criteria
Inclusion
- STEPPAGE foot walking in a patient with a central neurological disease
- can walk for 50 meters with or without technical assistance
- stable disease for at least 1 year
- possible walk with a brace-type reliever
- verification of possible nerve stimulation
- age greater than or equal to 18 years and under 75 years
- no toxin for 4 months
- no alcohol for 6 months
- no neurotomy for 1 year
- patient who agreed to sign an informed consent to participate in the study
Exclusion
- cons-indication to general anesthesia
- wearing a stimulator implanted for other reasons
- patients taking neuroleptics, benzodiazepines, or antidepressants or other drugs that interfere with the quality of walking
- advanced peripheral neuropathy
- excessive restriction of passive range of ankle
- poorly controlled epilepsy
- pregnant or lactating
- non-membership of a social security scheme
- wearing orthopaedic shoes including the malleolus
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01415700
Start Date
October 1 2010
End Date
January 1 2014
Last Update
July 28 2014
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94010