Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

Study Overview
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Brief Summary
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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 floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor. The aim of this study is to compare the results of the implementation of an implanted stimulator in the levator muscles of the foot to the results obtained by wearing a splint-type reliever, which is considered standard treatment, in order to determine if the implanted stimulation may be proposed in the treatment of foot drop off a neurological center.

Detailed Description
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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 floor by removing the STEPPAGE, reducing the effort of walking, facilitating the flow and removing anomalies compensatory (such as the mowing of the hip). Its objective is to improve the patient's autonomy locomotor.

Official Title
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Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack

Conditions
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Hysterical Simulation of Disease

Intervention / Treatment
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* Device: Functional electrical stimulator
* Device: feet orthosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulator<br> | Device: Functional electrical stimulator<br>* The stimulator is surgically implanted<br>|
| Active Comparator: Orthosis<br> | Device: feet orthosis<br>* feet orthosis specifically mold<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of walking speed at 3 months | The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement | Measurement will be performed at 3 months | 
| Measurement of walking speed at 6 months | The measurement is taken for a spontaneous march floor then fast. It follows from the establishment of the average of 3 to 5 passes on a walking track of a platform for analysis of movement | Measurement will be performed at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feet STEPPAGE of central neurological origin, implanted functional electrical stimulation, feet orthosis