Clinical trial NCT00276185: HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemiplegia
Keywords: spasticity ;
Botulinum toxin ;
Upper limb ;
motor function.
spastic hemiplegia after stoke
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: J. Rebeyrol Hospital in Limoges
name: Rennes University Hospital
name: Center of Physical Medicine and Rehabilitation (Notre Dame de Lourdes Center in Rennes)
name: Saint Jacques Hospital in Nantes
name: Centre Hospitalier Universitaire de Saint Etienne
name: Centre Régional de Département de médecine physique et réadaptation CHU-C3RF in Angers
name: Centre Hospitalier Universitaire de Besancon
First posted: 2006-01-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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
* 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

Primary outcomes:
measure: Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
measure: Box and blocks test
measure: Enjalbert test
measure: Modified Ashworth scale (upper limb)
measure: Functional Independence Measure
measure: Fugl-Meyer upper limb test
measure: Clinical Global Impression (CGI)
measure: 36-Item Short Form (SF-36) quality of life
Secondary outcomes:
measure: Range of pain
measure: Individual functional kinesitherapy
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Franck Durif
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wissel J, Muller 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. doi: 10.1016/s0885-3924(00)00146-9.