Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-01-31

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.

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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.

Conditions

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Hysterical Simulation of Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stimulator

Group Type EXPERIMENTAL

Functional electrical stimulator

Intervention Type DEVICE

The stimulator is surgically implanted

Orthosis

Group Type ACTIVE_COMPARATOR

feet orthosis

Intervention Type DEVICE

feet orthosis specifically mold

Interventions

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Functional electrical stimulator

The stimulator is surgically implanted

Intervention Type DEVICE

feet orthosis

feet orthosis specifically mold

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No