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

Implanted Functional Electrical Stimulation of the Levators of the Ankle Versus Orthosis in the Treatment of Chronic Foot Neurological STEPPAGE-gait by Central Attack

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.

Study Overview

• Status: Completed
• Conditions: Hysterical Simulation of Disease
• Intervention / Treatment: Device: Functional electrical stimulator; Device: feet orthosis

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulator	Device: Functional electrical stimulator; The stimulator is surgically implanted
Active Comparator: Orthosis	Device: feet orthosis; feet orthosis specifically mold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of walking speed 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 will be performed at 3 months
Measurement of walking speed 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	Measurement will be performed at 6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe Decq, PUPH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: August 11, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 25, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: feet STEPPAGE of central neurological origin; implanted functional electrical stimulation; feet orthosis
• Other Study ID Numbers: P070155; 2007-A01444-49 (Other Identifier: ID RCB)