Treatment of Spastic Equinovarus Foot After Stroke

December 29, 2008 updated by: University Hospital, Limoges

Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France
        • Département de Médecine Physique et de Réadaptation
      • Limoges, France
        • Département de Médecine Physique et de Réadaptation, CHU Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Plantar contact during walking

Secondary Outcome Measures

Outcome Measure
Gait velocity
Barthel index
MIF
Autosatisfaction by EVA
Asworth scale
Ankle range of motion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jean-Yves Salle, MD, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 30, 2008

Last Update Submitted That Met QC Criteria

December 29, 2008

Last Verified

December 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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