Status:
UNKNOWN
Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Hemiplegic Patients Post-AVC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due...
Eligibility Criteria
Inclusion
- More than 18-years-old Patient
- Patient presenting a hemiplegia séquellaire of an AVC above - tentoriel dating more than 12 months
- Patient presenting a spasticité of the muscles of the leg
- Patient for him(it) ( a ) which an indication of treatment(processing) by botulinal toxin is carried(worn)
- Patient not having received from treatment(processing) by botulinal toxin at the level of the lower limb for six months
- Patient not having benefited from alcoholization or surgical gesture(movement) at the level of the lower limb for twelve months
- Spasticité focused the muscles of leg: soleus, gastrocnémiens, with score of Ashworth \> or = 2 on the concerned muscles and/or the presence of a clonus on the soleus or gastrocnémiens,
Exclusion
- Patient for him(it) ( a ) which the upright posture and/or the walking(step) are impossible
- Patient presenting a contraindication to the use of the botulinal toxin
- Patient presenting a contraindication to the use of the intramuscular way
- Patient susceptible not to participate in the totality of the study
- Woman pregnant or susceptible to be pregnant during the year
- Patient who can not give himself(itself) his consent (held(detained), major under guardianship)
- Patient incapable to understand(include) the nature and the purposes of the study, or presenting difficulties of understanding which can compromise the good progress of the study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01829763
Start Date
April 1 2013
End Date
November 1 2015
Last Update
July 24 2014
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354