Status:
COMPLETED
Efficiency of Botulinum Toxin Injection for Spastic Equinovarus Foot in Post Stroke Hemiparetic Patients
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Spastic Equinovarus Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Botulinum toxin is the main treatment for focal spasticity but the effects of botulinum toxin injections with respect to limitations of gait activities are still discussed. The aim of this study is to...
Detailed Description
Multicenter, randomized, active treatment versus placebo, double-blind trial. Hemiplegia by stroke is the leading cause of disability in adults in France (145 new cases per 100 000 population), a sou...
Eligibility Criteria
Inclusion
- Chronic stroke hemiplegic patients presenting lower limb spasticity
- A minimum 12-month interval since stroke,
- Lower limb spasticity with a Modified Ashworth Scale greater than or equal to 2 on the triceps surae
- Minimum 6-month interval since a previous BTx-A injection
- To be older than 18 years.
- Patients must have an indication of treatment with Botulinum toxin, determined by a Physical and Rehabilitation Medicine specialist, based on clinical examination and gait analysis
Exclusion
- Contraindication to the use of botulinum toxin: Myastenia, Lambert Eaton syndrome, ALS, pregnancy, breast-feeding, treatment with aminoglycoside, cyclosporine, previous hypersensitivity to botulinum toxin
- Contraindication to intramuscular injections
- Patients unable to give consent
Key Trial Info
Start Date :
May 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2010
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03405948
Start Date
May 19 2006
End Date
November 17 2010
Last Update
January 23 2018
Active Locations (1)
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1
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354