- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00199589
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
-
-
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Bordeaux, France
- Département de Médecine Physique et de Réadaptation
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Limoges, France
- Département de Médecine Physique et de Réadaptation, CHU Limoges
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-
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 |
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Plantar contact during walking
|
Secondary Outcome Measures
Outcome Measure |
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Gait velocity
|
Barthel index
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MIF
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Autosatisfaction by EVA
|
Asworth scale
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Ankle range of motion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Congenital Abnormalities
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Musculoskeletal Abnormalities
- Muscle Hypertonia
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Lower Extremity Deformities, Congenital
- Muscle Spasticity
- Clubfoot
- Talipes
- Equinus Deformity
Other Study ID Numbers
- I01014
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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