Swiss Cerebral Palsy Registry

Study Overview
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Brief Summary
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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 will be 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.

Detailed Description
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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: Establish a representative population-based Swiss cohort of children, adolescents and adults with CP Provide epidemiological data to investigate the incidence, prevalence, risk factors, spectrum of diagnosis, survival rates and mortality Provide a platform for clinical research: Answer questions in the following areas: health, health care, education, social aspects and quality of life Offer a resource to recruit patients for nested observational and intervention studies Provide a platform for communication: Promote the exchange of knowledge between clinics, researchers, therapists and national and cantonal health authorities Facilitate international collaborations, in particular with the Surveillance of Cerebral Palsy of Europe (SCPE), and benchmarking of used therapeutic approaches with international partners Inclusion/exclusion criteria: all children, adolescents and adults diagnosed with CP who are born, treated or living in Switzerland. The SCPE decision tree is used for inclusion/exclusion. Patients with pure muscular hypotonia, neurometabolic diseases (e.g. neuronal storage diseases, leukodystrophies) and other progressive neurological diseases (e.g. spinocerebellar ataxias, hereditary spastic paraplegia, Rett syndrome, epileptic encephalopathy) are excluded. Procedure: After a CP diagnosis of a child, the treating physician informs the family during a consultation in a clinic or practice in writing and orally about the Swiss-CP-Reg. Families who wish to participate sign the consent form and the children are registered in the Swiss-CP-Reg. If families do not wish to participate, only a minimal anonymous data set is recorded. The following data will be collected: Medical data Data from questionnaires for patients and families Data from links to routine statistics and medical registries Clinical data (report of new cases and follow-up reports): CP Classification; Perinatal history; Diagnosis information; Possible CP causes; Neuroradiological examinations; Classification of motor skills (mobility, manual ability); Comorbidities, e.g. epilepsy, visual impairment, pain; Development and learning difficulties; Communication and nutrition; Hip and spinal pathologies (e.g. scoliosis); Treatments and therapies e.g. physiotherapy, hip surgery, medication; Socio-economic resources of the family. Questionnaire data: Personal information; Health-related quality of life; Participation in daily life; Medical care and medication; Communication and dietary problems; Comorbidities; Treatments; Aids; Education and social environment; Family needs Routine data and linkages: Communities; Federal Statistical Office (e.g. the birth register, cause of death statistics, hospital statistics); SwissNeoNet (register for premature and at-risk children). Current status: From 2017-2021, the investigators have included 580 persons diagnosed with CP (Status May 31 2021; from birth year 1998) The Swiss-CP-Reg contact new diagnosed persons with CP at regular intervals, and continuously analyse and publish data and findings. Funding: Swiss Foundation for the Cerebrally Palsied Child, Anna Mueller Grocholski Foundation, Swiss Academy of Childhood Disability SACD, Hand in Hand Anstalt, Ostschweizer Kinderspital and ACCENTUS Charitable Foundation (Walter Muggli Fund).

Official Title
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Swiss Cerebral Palsy Registry

Conditions
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Cerebral Palsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient population<br>Children, adolescents and adults diagnosed with cerebral palsy who are born, treated or living in Switzerland | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal data | Registering patients personal data | At diagnosis (age 0-5 years) | 
| Change in date of registration | Change in date of last consultation at physician for data collection | 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)) | 
| Birth history neonatal care | Maternal birth history | At diagnosis (age 0-5 years) | 
| Cause of change in vital status | what caused a change in patients vital status | 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)) | 
| Neonatal care | Neonatal care | At diagnosis (age 0-5 years) | 
| Age | Age at diagnosis | At diagnosis (age 0-5 years) | 
| Change in classification of CP | Change in CP classification according to SCPE decision tree | 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 gross motor function | Change in classification of gross motor function | 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 fine motor function | Change in classification of fine motor function | 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)) | 
| Postneonatal CP | Classification of postneonatal CP | At diagnosis (age 0-5 years) | 
| Change in associated syndromes | Change in classification of associated syndromes using ICD code | 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 of congenital anomalies | Change in classification of congenital anomalies using ICD code | 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 of brain malformation | Change in classification of brain malformation using ICD code | 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 genetic syndromes | Change in analysis results on genetic mutation | 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 neuroimaging | Registration of change in neuro images | 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 anthropometrics | Registration of change in anthropometric data | 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 sensory difficulties | Registration of change in sensory capability | 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 nutrition | Registration of change in feeding habits | 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 speech | Change in classification of verbal communication using VSS | 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 communication | Change in classification of communication using CFCS | 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 comorbidities | Registration of change in comorbidities | 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 of hip | Hip surveillance: registration of change in hip-dislocation | 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 of scoliosis | Assessing change in scoliosis using Cobb Winkel | 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 surgery | Registering changes in surgery history | 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 treatments | Registering changes in treatments | 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 therapies | Registering changes in therapies | 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)) | 
| Changes in medical equipment | Registering changes in use of medical equipment | 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 ancillary service | Registering changes in use of ancillary service | 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 mobility | Registering changes in mobility | 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 cognition | Assessing changes in mental ability using tests | 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)) | 
| Changes in behavior | Assessing changes in behavior using scales | 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)) | 
| Changes in academic info | Registering changes in info on academic education | 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)) | 
| Changes in family history | Registering changes in info on health of family members | 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)) | 
| Changes in socio economics | Registering changes in info on parents socio-economic background | 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)) | 
| Changes in epilepsy | Registration changes in epilepsy | 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)) | 
| Questionnaire data | Questionnaires focusing on specific research questions (Perinatal history, health related questions, health behavior, quality of life, participation, needs, concerns) | 5-80 years |