Comparison Between Implanted Functional Electrical Stimul... | NCT01415700

Studies
Comparison Between Implanted Functional Electrical Stimulation and Foot Orthosis

NCT01415700

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jul 28, 2014Estimated

Enrollment

27Actual

Phase

Not Applicable

Conditions

Hysterical Simulation of Disease

Interventions

Functional electrical stimulator
feet orthosis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-A01444-49	Other Identifier	ID RCB

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Aug 8, 2011

First Submission Date that Met QC Criteria

Aug 11, 2011

First Posted Date

Aug 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stimulator	Experimental		Device: Functional electrical stimulator
Orthosis	Active Comparator		Device: feet orthosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional electrical stimulator	Device	The stimulator is surgically implanted	Stimulator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Decq, PUPH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henri Mondor Hospital		Créteil		94010	France