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