Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis (STEPSTIM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hysterical Simulation of Disease

Treatments: Device: feet orthosis; Device: Functional electrical stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT01415700

2007-A01444-49 (Other Identifier)

P070155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Stimulator

Experimental group

Treatment:

Device: Functional electrical stimulator

Orthosis

Active Comparator group

Treatment:

Device: feet orthosis