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

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01415700
First received: August 8, 2011
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  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: 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:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Estimated 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
Other Name: Functional electrical stimulator
Active Comparator: Orthosis Device: feet orthosis
feet orthosis specifically mold
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415700

Contacts
Contact: Philippe Decq, PUPH (0) 149812201 ext +33 philippe.decq@hmn.aphp.fr
Contact: Henintsoa Randrianalivelo (0) 149813752 ext +33 henintsoa.randrianalivelo@hmn.aphp.fr

Locations
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Philippe Decq, PUPH     (0) 149812201 ext +33     philippe.decq@hmn.aphp.fr    
Contact: Henintsoa Randrianalivelo     (0) 149813752 ext +33     henintsoa.randrianalivelo@hmn.aphp.fr    
Principal Investigator: Philippe Decq, PUPH            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Philippe Decq, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01415700     History of Changes
Other Study ID Numbers: P070155, 2007-A01444-49
Study First Received: August 8, 2011
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013