Hysterical Simulation of Disease
Conditions
Keywords
feet STEPPAGE of central neurological origin, implanted functional electrical stimulation, feet orthosis
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.
Interventions
DEVICEFunctional electrical stimulator
The stimulator is surgically implanted
DEVICEfeet orthosis
feet orthosis specifically mold
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of walking speed at 3 months | Measurement will be performed 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 of walking speed at 6 months | Measurement will be performed 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 |
Countries
France
Outcome results
None listed