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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00276185
• Other study ID #: CHU63-0003
• Status: Recruiting
• Phase: Phase 3
• First received: January 12, 2006
• Last updated: January 18, 2011
• Start date: December 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Franck Durif
• Phone: (33) 04 73 750 750
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Drug:
• Time delay treatment of botulinum toxin

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	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

Country where clinical trial is conducted

France, 

References & Publications (1)

Wissel J, Müller J, Dressnandt J, Heinen F, Naumann M, Topka H, Poewe W. Management of spasticity associated pain with botulinum toxin A. J Pain Symptom Manage. 2000 Jul;20(1):44-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
Primary	Box and blocks test
Primary	Enjalbert test
Primary	Modified Ashworth scale (upper limb)
Primary	Functional Independence Measure
Primary	Fugl-Meyer upper limb test
Primary	Clinical Global Impression (CGI)
Primary	36-Item Short Form (SF-36) quality of life
Secondary	Range of pain
Secondary	Individual functional kinesitherapy