Completed

NCT Number: NCT01415700

Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

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.

Completed

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Key information

Conditions

Hysterical Simulation of Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

About this study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional electrical stimulator

Device

The stimulator is surgically implanted

feet orthosis

Device

feet orthosis specifically mold

Primary outcomes

Measurement of walking speed at 3 months

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: STEPSTIM

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2014
First posted: Aug 12, 2011
Registry last updated: Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.