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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Hemiplegia Drug: Time delay treatment of botulinum toxin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : December 2005
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : December 2009
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
  2. Box and blocks test
  3. Enjalbert test
  4. Modified Ashworth scale (upper limb)
  5. Functional Independence Measure
  6. Fugl-Meyer upper limb test
  7. Clinical Global Impression (CGI)
  8. 36-Item Short Form (SF-36) quality of life

Secondary Outcome Measures :
  1. Range of pain
  2. Individual functional kinesitherapy

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00276185


Contacts
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Contact: Franck Durif (33) 04 73 750 750

Locations
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France
Clermont-Ferrand University Hospital Recruiting
Clermont-Ferrand, Auvergne, France, 63000
Contact: Franck Durif    (33) 04 73 750 750      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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
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Principal Investigator: Franck Durif University Hospital, Clermont-Ferrand
More Information
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Publications of Results:

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Responsible Party: Pr Franck DURIF, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00276185    
Other Study ID Numbers: CHU63-0003
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011
Keywords provided by University Hospital, Clermont-Ferrand:
spasticity ;
Botulinum toxin ;
Upper limb ;
motor function.
spastic hemiplegia after stoke
Additional relevant MeSH terms:
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Muscle Spasticity
Hemiplegia
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Paralysis
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs