HEMITOX : 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-Ferrand

Status and phase

Unknown

Phase 3

Conditions

Hemiplegia

Treatments

Drug: Time delay treatment of botulinum toxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00276185

CHU63-0003

Details and patient eligibility

About

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).

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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