Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin injections and intensive functional physiotherapy.
- Conditions
- Spastic Cerebral Palsy, GMFCS levels I-III
- Registration Number
- EUCTR2009-009868-31-NL
- Lead Sponsor
- ZonMW
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Children with spastic Cerebral Palsy aged 4-12 years whose lower extremity is involved and who have been selected for treatment with multilevel botulinum toxin injections followed by intensive physiotherapy are eligible candidates.
Spastic CP will be diagnosed according to the guidelines of the Dutch Institute for Healthcare Improvement. Only children classified as levels I-III with the Gross Motor Function Classification System (GMFCS) will be included for the study because they are (household) ambulators.
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’s´ motor selectivity should be sufficient (to be measured by valid selectivity test), and they are excluded in case of surgery <12 months before the study and in case of BtA treatment <6 months preceding the study. Children will also be excluded when severe contractures are present, when they are cognitively unable to understand instructions, or when there is co-morbidity (e.g. visual disability, severe epilepsis) that affects their everyday functioning.
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