Status:

COMPLETED

Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Hysterical Simulation of Disease

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

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 ...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT01415700

Start Date

October 1 2010

End Date

January 1 2014

Last Update

July 28 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Henri Mondor Hospital

Créteil, France, 94010