Treatment of Spastic Equinovarus Foot After Stroke | NCT00199589

Studies
Treatment of Spastic Equinovarus Foot After Stroke

NCT00199589

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Dec 30, 2008Estimated

Enrollment

46Estimated

Phase

Not Applicable

Conditions

Spastic Equinovarus

Interventions

Botulinic toxin (Botox)

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

Status Module

Record Verification Date

Dec 2008

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 2002

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 20, 2005Estimated

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

Dec 29, 2008

Last Update Posted Date

Dec 30, 2008Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

Detailed Description

This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles [300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection]. The patients are followed for one year after treatment.

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

46Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinic toxin (Botox)	Drug	Patients may benefit, depending on the draw, in addition to their orthosis, intramuscular injections of botulinum toxin.These injections are among 6 in the muscles posterior (rear) of the leg paralyzed with tracking electromyographic to ensure the accuracy of the injection.

Measure	Description	Time Frame
Plantar contact during walking

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
Ability to walk for at least 10 meters with or without aid
Stroke interval < 12 months
Age > 18 years old
Weight > 30 kg and < 100 kg
Written informed consent

Exclusion Criteria:

Stroke interval > 12 months
Age < 18 years old
Pregnancy
Neuromuscular disease
Previous treatment with BTA
Fixed contractures impairing mobility
Mini-Mental Status Examination < 25
Aminosides treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Yves Salle, MD	University Hospital, Limoges	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département de Médecine Physique et de Réadaptation		Bordeaux			France
Département de Médecine Physique et de Réadaptation, CHU Limoges

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Gait velocity
Barthel index
MIF