Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

Not Applicable

Completed

• Conditions: Hysterical Simulation of Disease
• Interventions: Device: Functional electrical stimulator; Device: feet orthosis

• Registration Number: NCT01415700
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-25
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulator	Functional electrical stimulator	-
Orthosis	feet orthosis	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France