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HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke

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ClinicalTrials.gov Identifier: NCT00276185
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : January 13, 2006
Last Update Posted : January 19, 2011
Sponsor:
Collaborators:
J. Rebeyrol Hospital in Limoges
Rennes University Hospital
Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
Saint Jacques Hospital in Nantes
Centre Hospitalier Universitaire de Saint Etienne
Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
Centre Hospitalier Universitaire de Besancon
Information provided by:
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date January 19, 2011
Study Start Date  ICMJE December 2005
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2007)
  • 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 Measures  ICMJE
 (submitted: January 12, 2006)
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • Range of pain
  • Individual functional kinesitherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hemiplegia
Intervention  ICMJE Drug: Time delay treatment of botulinum toxin
Study Arms  ICMJE Not Provided
Publications * Wissel J, Muller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9. doi: 10.1016/s0885-3924(00)00146-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 12, 2006)		 180
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Minimum age 18
  • Spastic hemiplegia after ischemic stroke (carotid occlusion) within the past 3 months.
  • Antispasticity medication stabilized for the last 30 days
  • Severe cognitive impairment such that patient is unable to provide scale assessment.
  • Significant spasticity impeding improvement by re-education for 2 months or less

  • Lack of muscular retraction defined by a minimal range of articular motion as :

    • finger : complete extension and rolling up
    • wrist : extension 40°/flexion : 45°
    • elbow : extension - 10°/flexion : 120°
    • shoulder : Enjalbert score 2 or more
  • Antagonist muscles (to spasticity) activity score 1 or more
  • Social Security benefits

Exclusion Criteria:

  • Ischemic stroke thought to be due to basilar or vertebral vessel occlusion
  • Known motor neuron or neuromuscular junction disease, disorders in which pain limits the ability to inject muscles (algodystrophy)
  • Absence of mobility in proximal part of upper limb that does not predict a functional gain
  • Minor stroke with non-disabling deficit or rapidly improving motor symptoms
  • other serious illness, e.g. severe hepatic, cardiac, or renal failure ; acute myocardial infarction ; or a complex disease that may confound treatment assessment
  • Treatment of spasticity by previous administration of botulinum toxin, if known
  • Known allergy to botulinum toxin
  • Currently participating in other research studies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276185
Other Study ID Numbers  ICMJE CHU63-0003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pr Franck DURIF, CHU Clermont-Ferrand
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • J. Rebeyrol Hospital in Limoges
  • Rennes University Hospital
  • Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
  • Saint Jacques Hospital in Nantes
  • Centre Hospitalier Universitaire de Saint Etienne
  • Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
  • Centre Hospitalier Universitaire de Besancon
Investigators  ICMJE
Principal Investigator: Franck Durif University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP