A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 499
- Locations
- 20
- Primary Endpoint
- Quantify current CP characteristics 7 (nutritional status)
Study Overview
Brief Summary
HCPs will complete questionnaires about their patients with Cerebral Palsy (CP) and invite parents/caregivers of these patients to fill in questionnaires as well. Questionnaires include questions on individualized treatment, nutritional profile and management, and patient characteristics.
Detailed Description
Coordinating health care professionals (HCPs; e.g. paediatric neurologists, physiotherapists) in different centres across different countries will be asked to participate in this cross-sectional study.
A) for the HCP to fill out a questionnaire about their CP child, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status; and B) for parents (/legal representatives) to receive and fill out questionnaires about their CP child and themselves, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status, participation and (their own) quality of life.
If parents (/legal representatives) agree to "A)", but not "B)" then a subject will still enter the study, but without the parental assessment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 1 Month to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of Cerebral Palsy
- •Age<18 years
- •Have visited the HCP within the last year
- •Written informed consent provided by parents/legal representatives according to local law
Exclusion Criteria
- •Neurodegenerative diseases
- •Acute infections: meningitis, encephalitis or poliomyelitis
Outcomes
Primary Outcomes
Quantify current CP characteristics 7 (nutritional status)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Nutritional status (HCP and parent perspective on nutritional status, concerns \[yes/no\])
Quantify current CP characteristics 1 (general subject characteristics):
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: - General subject characteristics (e.g. Sex, Birth weight \[g\], Type of CP motor disorder \[category\]
Quantify current CP characteristics 2 (anthropometry):
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Anthropometry: length \[cm\]; weight \[grams\] and BMI (kg/m2)
Quantify current CP characteristics 3 (motor function)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Motor function (GMFCS \[category\]; GMFM measurement type \[GMFM-86/GMFM-88\]
Quantify current CP characteristics 4 (comorbidities)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Comorbidities: epilepsy, cognitive function, GI problems \[categories\]
Quantify current CP characteristics 5 (therapies)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Type and frequency of physical/occupational therapy \[type, number of hours per day /days per week\]
Quantify current CP characteristics 6 (feeding mode)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
Using questionnaires to quantify current CP characteristics with respect to: Feeding mode and/or problems (tube feeding \[yes/no\], type of tube feeding etc)
Secondary Outcomes
No secondary outcomes reported