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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00276185 |
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Date of registration:
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12/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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HEMITOX : Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke
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Scientific title:
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Effect of Botulinum Toxin Injections on Motor and Functional Ability of Upper Limb in Adults at Earlier Phases of Spastic Hemiplegia After Stroke |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00276185 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Franck Durif |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Clermont-Ferrand |
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Name:
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Franck Durif |
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Address:
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Telephone:
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(33) 04 73 750 750 |
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Email:
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Affiliation:
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Name:
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Franck Durif |
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Address:
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Telephone:
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(33) 04 73 750 750 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemiplegia
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Intervention(s)
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Drug: Time delay treatment of botulinum toxin
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Primary Outcome(s)
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Deficiency, incapacity, handicap : Frenchay Arm test(post stroke arm function); Enjalbert test;
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Clinical Global Impression (CGI)
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Fugl-Meyer upper limb test
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Modified Ashworth scale (upper limb)
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Enjalbert test
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Functional Independence Measure
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36-Item Short Form (SF-36) quality of life
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Box and blocks test
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Secondary Outcome(s)
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Range of pain
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Individual functional kinesitherapy
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Secondary ID(s)
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CHU63-0003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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