Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199589
Status:
COMPLETED
Last Update Posted:
2008-12-30
First Post:
2005-09-14
Brief Title:
Treatment of Spastic Equinovarus Foot After Stroke
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
Treatment of Spastic Equinovarus Foot After Stroke Efficacy Association Between Ankle Foot Orthosis and Botulinum Toxin A BTA Injection
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor posterior andor the long toe flexor andor medial and lateral gastrocnemius andor soleus muscles 300 BTA U per injection Botox - Allergan diluted with saline to a concentration of 5U01 mL with electromyography guided injection The patients are followed for one year after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None