Status:
COMPLETED
Treatment of Spastic Equinovarus Foot After Stroke
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Allergan
Conditions:
Spastic Equinovarus
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00199589
Start Date
October 1 2002
End Date
December 1 2007
Last Update
December 30 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Département de Médecine Physique et de Réadaptation
Bordeaux, France
2
Département de Médecine Physique et de Réadaptation, CHU Limoges
Limoges, France