Clinical trial NCT01415700: Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis
Official title: Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterical Simulation of Disease
Keywords: feet STEPPAGE of central neurological origin
implanted functional electrical stimulation
feet orthosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of walking speed at 3 months
timeFrame: Measurement will be performed at 3 months
measure: Measurement of walking speed at 6 months
timeFrame: Measurement will be performed at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Decq, PUPH
role: PRINCIPAL_INVESTIGATOR
References: