We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415700
First Posted: August 12, 2011
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose

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.


Condition Intervention
Hysterical Simulation of Disease Device: Functional electrical stimulator Device: feet orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Enrollment: 27
Study Start Date: October 2010
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stimulator Device: Functional electrical stimulator
The stimulator is surgically implanted
Active Comparator: Orthosis Device: feet orthosis
feet orthosis specifically mold

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415700


Locations
France
Henri Mondor Hospital
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Decq, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01415700     History of Changes
Other Study ID Numbers: P070155
2007-A01444-49 ( Other Identifier: ID RCB )
First Submitted: August 8, 2011
First Posted: August 12, 2011
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
feet STEPPAGE of central neurological origin
implanted functional electrical stimulation
feet orthosis


To Top