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

University Hospital, Clermont-Ferrand1 site in 1 country180 target enrollmentDecember 2005

ConditionsHemiplegia

DrugsTime delay treatment of botulinum toxin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hemiplegia
Sponsor: University Hospital, Clermont-Ferrand
Enrollment: 180
Locations: 1
Primary Endpoint: Clinical Global Impression (CGI)
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

December 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Clermont-Ferrand

Eligibility 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

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