Kosten-effectiviteit van combinatie behandeling botuline-toxine injecties en intensieve fysiotherapie bij kinderen met spastische Cerebrale Parese.
- Conditions
- : (kosten-)effectiviteit, spastische cerebrale parese, botuline toxine, intensieve functionele fysiotherapie.EN: (cost-)effectiveness, spastic cerebral palsy, botulinum toxin, intensive functional physiotherapy.
- Registration Number
- NL-OMON27016
- Lead Sponsor
- Erasmus MC, dept. Rehabilitation Medicine PObox 2040, 3000 CA RotterdamThe Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Spastic cerebral palsy;
2. Aged 4-12 years;
Exclusion Criteria
1. Surgery < 12 months before study;
2. BtA treatment < 6 months before study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary measures are:<br /> <br>1. Functional health status as measured by the Child Health Questionnaire (CHQ) Child and Parent Forms;<br /> <br>2. A condition-specific DISABKIDS health related quality of life questionnaire for CP;<br /> <br>3. The level of actually performed everyday physical activities (‘actual performance’) as measured with valid and reliable several-day ambulatory monitoring techniques;<br /> <br>4. Gross motor functioning as measured using the Gross Motor Function Measure (GMFM66).<br /><br>Cost-utility analyses will be done using costs per quality adjusted life year (QALY) as primary outcome measure. The Health Utilities Index (HUI) will be the primary outcome measure for the economic evaluation.
- Secondary Outcome Measures
Name Time Method 1. Instrumented clinical gait analysis (‘actual capacity’) using video observation, force platform, and EMG measurements;<br /><br>2. (Perceived changes in) functional activities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI);<br /> <br>3. Spasticity, as measured with a modified Tardieu scale;<br /><br>4. Muscle force (or weakness) will be measured using an isometric hand-held dynamometer;<br /><br>5. Muscle length / passive range of motion will be measured in standardized postures using a goniometer;<br /><br>6. Pain intensity will be measured using a Visual Analogue Scale (VAS) for children.