Kosten-effectiviteit van combinatie behandeling botuline-toxine injecties en intensieve fysiotherapie bij kinderen met spastische Cerebrale Parese.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27016

Enrollment

Registered

2009-02-02

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NL: (kosten-)effectiviteit, spastische cerebrale parese, botuline toxine, intensieve functionele fysiotherapie. EN: (cost-)effectiveness, spastic cerebral palsy, botulinum toxin, intensive functional physiotherapy.

Interventions

A 2-group RCT will be conducted: one intervention group will receive combined multilevel BtA+iPT treatment (multiple botulinum toxin injections followed by a 12-week period of intensive physiotherapy

Eligibility

Inclusion criteria

Inclusion criteria: 1. Spastic cerebral palsy; 2. Aged 4-12 years; 3. Lower extremity primarily involved; 4. GMFCS levels I-III; 5. Sufficient motor selectivity.

Exclusion criteria

Exclusion criteria: 1. Surgery < 12 months before study; 2. BtA treatment < 6 months before study; 3. Severe contractures; 4. Cognitively unable to follow instructions; 5. Co-morbidity affecting everyday functioning.

Design outcomes

Primary

Measure	Time frame
Primary measures are: 1. Functional health status as measured by the Child Health Questionnaire (CHQ) Child and Parent Forms; 2. A condition-specific DISABKIDS health related quality of life questionnaire for CP; 3. The level of actually performed everyday physical activities (‘actual performance’) as measured with valid and reliable several-day ambulatory monitoring techniques; 4. Gross motor functioning as measured using the Gross Motor Function Measure (GMFM66). 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.	—

Measure

Time frame

Primary measures are: 1. Functional health status as measured by the Child Health Questionnaire (CHQ) Child and Parent Forms; 2. A condition-specific DISABKIDS health related quality of life questionnaire for CP; 3. The level of actually performed everyday physical activities (‘actual performance’) as measured with valid and reliable several-day ambulatory monitoring techniques; 4. Gross motor functioning as measured using the Gross Motor Function Measure (GMFM66). 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

Measure	Time frame
1. Instrumented clinical gait analysis (‘actual capacity’) using video observation, force platform, and EMG measurements; 2. (Perceived changes in) functional activities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI); 3. Spasticity, as measured with a modified Tardieu scale; 4. Muscle force (or weakness) will be measured using an isometric hand-held dynamometer; 5. Muscle length / passive range of motion will be measured in standardized postures using a goniometer; 6. Pain intensity will be measured using a Visual Analogue Scale (VAS) for children.	—

Measure

Time frame

1. Instrumented clinical gait analysis (‘actual capacity’) using video observation, force platform, and EMG measurements; 2. (Perceived changes in) functional activities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI); 3. Spasticity, as measured with a modified Tardieu scale; 4. Muscle force (or weakness) will be measured using an isometric hand-held dynamometer; 5. Muscle length / passive range of motion will be measured in standardized postures using a goniometer; 6. Pain intensity will be measured using a Visual Analogue Scale (VAS) for children.

—

Contacts

Public ContactF. Schasfoort

Erasmus MC, Rehabilitation Medicine PObox 2040

f.schasfoort@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)