Treatment of Spastic Equinovarus Foot After Stroke
- Conditions
- Spastic Equinovarus
- Registration Number
- NCT00199589
- Lead Sponsor
- University Hospital, Limoges
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Plantar contact during walking
- Secondary Outcome Measures
Name Time Method Gait velocity Barthel index MIF Autosatisfaction by EVA Asworth scale Ankle range of motion
Trial Locations
- Locations (2)
Département de Médecine Physique et de Réadaptation
🇫🇷Bordeaux, France
Département de Médecine Physique et de Réadaptation, CHU Limoges
🇫🇷Limoges, France