Clinical Trial: Treatment of Spastic Equinovarus Foot After Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Spastic Equinovarus Foot After Stroke. Efficacy: Association Between Ankle Foot Orthosis and Botulinum Toxin A (BTA) Injection
Brief Summary: This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).
Detailed Summary: 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.
Sponsor: University Hospital, Limoges
Current Primary Outcome: Plantar contact during walking
Original Primary Outcome: - Plantar contact during walking
Current Secondary Outcome:
- Gait velocity
- Barthel index
- MIF
- Autosatisfaction by EVA
- Asworth scale
- Ankle range of motion
Original Secondary Outcome:
- Gait velocity
- Barthel index
- MIF
- Autosatisfaction by EVA
- Asworth scale
- -ankle range of motion.
Information By: University Hospital, Limoges
Dates:
Date Received: September 14, 2005
Date Started: October 2002
Date Completion:
Last Updated: December 29, 2008
Last Verified: December 2008