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

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 = 6 months). Phase: Phase 3Accepts Healthy Volunteers? No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes); Centre Hospitalier Universitaire de Besancon; Centre Hospitalier Universitaire de Saint Etienne; Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers; J. Rebeyrol Hospital in Limoges; Rennes University Hospital; Saint Jacques Hospital in Nantes
• Treatments: Botulinum Toxins

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