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

Phase 3

• Conditions: Hemiplegia

• Registration Number: NCT00276185
• Lead Sponsor: University Hospital, Clermont-Ferrand

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Primary Completion: 2009-01
• Study Completion: 2009-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)
Box and blocks test
Enjalbert test
Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Functional Independence Measure
Modified Ashworth scale (upper limb)
36-Item Short Form (SF-36) quality of life
Fugl-Meyer upper limb test

Secondary Outcome Measures

Name	Time	Method
Range of pain
Individual functional kinesitherapy

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France