The efficacy of the Botulinum toxin-A on the manual abilities in children with congenital spastic hemiplegia. Interest of the measure of the bimanual task performance.
- Conditions
- The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper Limb dysfunction in Hemiplegic Cerebral Palsy Children and in particular, its impact on Upper limb activity performance and how this might be translate in bimanual activities.MedDRA version: 12.0Level: LLTClassification code 10019475Term: Hemiplegic infantile cerebral palsy
- Registration Number
- EUCTR2009-015620-29-BE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
The participants to this study are aged between 4 and 12 years and have a diagnosis of congenital hemiplegia affecting upper-limb activities but not significative fixed contractures.
They have a Manual Ability Classification system( MACS) level between 1 and 4 and a normal education or an IQ > 70.
They must have an adapted physiotherapy program before and minimum 9 months after the treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The children who had injection within 6 months previous the inclusion in the lower limb and 9 months in the upper limb will be excluded. Children who participated at a constraint-induced therapy (CIMT) program the year before the study will be automatically excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method