Swiss Cerebral Palsy Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 12
- 主要终点
- Personal data
研究概览
简要总结
The Swiss-CP-Reg is a national patient registry that collects information on diagnosis, symptoms, treatment and follow-up of patients with cerebral palsy (CP) in Switzerland. It was first implemented in 2017 in the paediatric clinics in Basel, Bellinzona, Bern, Geneva, Lausanne, St. Gallen and Zurich. It is currently extended to all Swiss clinics and medical practices and adults will be invited to join the register in the coming years. The registry provides data for national and international monitoring and research. It supports research on CP in Switzerland and the exchange of knowledge between clinicians, researchers and therapists, with the goal to improve the treatment of children and adults with CP and optimizing their health and quality of life.
详细描述
Background: Cerebral palsy (CP) refers to chronic movement and postural disorders. It results from a non-progressive lesion or brain malformation that occurs during the prenatal, perinatal, or postnatal period (e.g. ischemic lesions of the neonatal brain or genetic predispositions leading to brain malformation). Besides motor dysfunction, persons with CP suffer from a wide variety of comorbidities, such as epilepsy, speech, hearing or vision disorders, cognitive dysfunction, behavioral disorders, and secondary musculoskeletal problems.
CP is the most common cause of physical disability in children in Switzerland and it is important that the investigators gain a better understanding of its prevalence, risk factors, current clinical profile and the needs of those affected and their families.
The cantonal Ethics Committee of Bern approved the Swiss-CP-Reg project (project ID: 2017-00873, observational study, risk category A).
Objectives: The overall objective of the Swiss-CP-Reg is to improve future care and thus well-being of CP individuals. The development of a national registry for the collection of representative, complete and longitudinal data from children, adolescents and adults with CP in Switzerland serves to achieve this goal.
Primary objectives of the Swiss-CP-Reg projects:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Who were diagnosed with CP, confirmation of the diagnosis at the age of 5 years is required
- •Who are born, treated for CP or living in Switzerland, and
- •Who gave informed consent
排除标准
- •Pure muscular hypotonia
- •Neurometabolic diseases (e.g. neuronal storage diseases, leukodystrophies)
- •Other progressive neurological diseases (e.g. spinocerebellar ataxias, hereditary spastic paraplegia, Rett syndrome, epileptic encephalopathy)
研究组 & 干预措施
Patient population
Children, adolescents and adults diagnosed with cerebral palsy who are born, treated or living in Switzerland
结局指标
主要结局
Personal data
时间窗: At diagnosis (age 0-5 years)
Registering patients personal data
Change in date of registration
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in date of last consultation at physician for data collection
Birth history neonatal care
时间窗: At diagnosis (age 0-5 years)
Maternal birth history
Cause of change in vital status
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
what caused a change in patients vital status
Neonatal care
时间窗: At diagnosis (age 0-5 years)
Neonatal care
Age
时间窗: At diagnosis (age 0-5 years)
Age at diagnosis
Change in classification of CP
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in CP classification according to SCPE decision tree
Change in gross motor function
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of gross motor function
Change in fine motor function
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of fine motor function
Postneonatal CP
时间窗: At diagnosis (age 0-5 years)
Classification of postneonatal CP
Change in associated syndromes
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of associated syndromes using ICD code
Change of congenital anomalies
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of congenital anomalies using ICD code
Change of brain malformation
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of brain malformation using ICD code
Change in genetic syndromes
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in analysis results on genetic mutation
Change in neuroimaging
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration of change in neuro images
Change in anthropometrics
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration of change in anthropometric data
Change in sensory difficulties
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration of change in sensory capability
Change in nutrition
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration of change in feeding habits
Change in speech
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of verbal communication using VSS
Change in communication
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Change in classification of communication using CFCS
Change in comorbidities
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration of change in comorbidities
Change of hip
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Hip surveillance: registration of change in hip-dislocation
Change of scoliosis
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Assessing change in scoliosis using Cobb Winkel
Change in surgery
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in surgery history
Change in treatments
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in treatments
Change in therapies
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in therapies
Changes in medical equipment
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in use of medical equipment
Change in ancillary service
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in use of ancillary service
Change in mobility
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in mobility
Changes in behavior
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Assessing changes in behavior using scales
Changes in academic info
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in info on academic education
Changes in family history
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in info on health of family members
Changes in socio economics
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registering changes in info on parents socio-economic background
Changes in epilepsy
时间窗: Baseline medical information, follow-up data collection at regular intervals (at diagnosis, at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Registration changes in epilepsy
Questionnaire data
时间窗: 5-80 years
Questionnaires focusing on specific research questions (Perinatal history, health related questions, health behavior, quality of life, participation, needs, concerns)
Change in cognition
时间窗: follow-up data collection at regular intervals (at age of 5, 10 and 15 years, and at the time of transition to adult care (18±2 years))
Assessing changes in mental ability using tests and school typ
次要结局
未报告次要终点