Status:
UNKNOWN
HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
J. Rebeyrol Hospital in Limoges
Rennes University Hospital
Conditions:
Hemiplegia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 fun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00276185
Start Date
December 1 2005
End Date
December 1 2009
Last Update
January 19 2011
Active Locations (1)
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1
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, France, 63000