A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 499
- 试验地点
- 20
- 主要终点
- Quantify current CP characteristics 7 (nutritional status)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Neurodegenerative diseases
- •Acute infections: meningitis, encephalitis or poliomyelitis
结局指标
主要结局
Quantify current CP characteristics 7 (nutritional status)
时间窗: 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):
时间窗: 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):
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
未报告次要终点