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治験 NCT04992871 (Swiss-CP-Reg)（対象：脳性麻痺）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ベルン大学Swiss Cerebral Palsy Registry (Swiss-CP-Reg) 15,000 国際共同
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT04992871 (Swiss-CP-Reg) は 観察研究 臨床試験 で、脳性麻痺 に関するものです。現在は 募集中 で、2017年6月19日 から開始しています。15,000 名の参加者 の募集が計画されています。この試験は ベルン大学 によって主導され、2071年1月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月13日 です。
概要
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 i...もっと見る
詳細説明
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, ...もっと見る
公式タイトル
Swiss Cerebral Palsy Registry
疾患名
脳性麻痺刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- Swiss-CP-Reg
- 2017-00873
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Patient population Children, adolescents and adults diagnosed with cerebral palsy who are born, treated or living in Switzerland | 該当なし |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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)) |
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 |
Change in cognition | Assessing changes in mental ability using tests and school typ | 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)) |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
0 Years
対象性別
全て
- 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
- 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)
ベルン大学178 件のアクティブな治験を探索- Schweizerische Stiftung für das cerebral gelähmte Kind
- SwissPedNet
試験中央連絡先
連絡先: Claudia E Kuehni, Prof. MD, +41 31 684 35 07, [email protected]
12 1カ国の場所
Aarau Cantonal Hospital, Aarau, Switzerland
Christina Rüsch, Dr. med, 連絡先
募集中
University Children's Hospital Basel, UKBB, Basel, Switzerland
Stephanie Jünemann, Dr. med, 連絡先
募集中
Pediatric Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona, Switzerland
Barbara B Goeggel-Simonetti, PD Dr. med, 連絡先
募集中
Institute of Social and Preventive Medicine (ISPM), University of Bern, Bern, Switzerland
Claudia E Kuehni, Prof. MD, 連絡先, +41 31 684 35 07, [email protected]
募集中
University Children's Hospital Bern, Inselspital, Bern, Switzerland
Sebastian Grunt, PD Dr. med, 連絡先
募集中
Zentrum für Entwicklungsförderung und pädiatrische Neurorehabilitation, Biel, Switzerland
Chantal Gammenthaler-Zaugg, Dr. med, 連絡先
募集中
University Hospitals of Geneva, Geneva, Switzerland
Joel Fluss, PD Dr, 連絡先
募集中
University Children's hospital Lausane, CHUV, Lausanne, Switzerland
Christopher Newman, PD Dr, 連絡先
募集中
Lucerne Cantonal Hospital, Lucerne, Switzerland
Mareike Schimmel, Dr. med, 連絡先
募集中
Children's Hospital of Eastern Switzerland, Sankt Gallen, Switzerland
Steffen Berweck, Prof Dr med, 連絡先
募集中
Zentrum für Kinder mit Sinnes- und Körperbeeinträchtigung, Solothurn, Switzerland
Letizia von Laer, Dr. med, 連絡先
募集中
University Children's Hospital Zurich, Zurich, Switzerland
Andreas Meyer-Heim, PD Dr. med, 連絡先
募集中