Clinical Trial: HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
Brief Summary: Botulinum toxin produced beneficial effects in spasticity in the hemiplegic upper limb. This study will test if botulinum toxin injections at earlier phases (<or = 3 months) in spasticity improve functional and motor tests compared with late injections (>or = 6 months).
Detailed Summary:
Sponsor: University Hospital, Clermont-Ferrand
Current Primary Outcome:
- Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
- Box and blocks test
- Enjalbert test
- Modified Ashworth scale (upper limb)
- Functional Independence Measure
- Fugl-Meyer upper limb test
- Clinical Global Impression (CGI)
- 36-Item Short Form (SF-36) quality of life
Original Primary Outcome:
- Deficiency, incapacity, handicap :
- Frenchay Arm Test (post stroke arm function)
- Box and blocks test
- Enjalbert test
- Modified Ashworth scale (upper limb)
- Functional Independance Measure
- Fugl-Meyer upper limb test
- CGI
- SF-36 quality of life
Current Secondary Outcome:
- Range of pain
- Individual functional kinesitherapy
Original Secondary Outcome: Same as current
Information By: University Hospital, Clermont-Ferrand
Dates:
Date Received: January 12, 2006
Date Started: December 2005
Date Completion: December 2009
Last Updated: January 18, 2011
Last Verified: January 2011