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临床试验 NCT05921422 (CPCog-Youth-DK) 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Cognitive Functioning in Children and Adolescents With Cerebral Palsy (CPCog-Youth-DK) 150 国际 儿科 青少年 学术主导
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临床试验NCT05921422 (CPCog-Youth-DK)是一项针对脑瘫的观察研究试验，目前试验状态为招募中。试验始于2023年7月1日，计划招募150名患者。该研究由Rigshospitalet, Denmark主导，预计于2026年12月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年6月27日。
简要概括
Background: Cerebral palsy (CP) is characterized by motor impairment but commonly involves more widespread difficulties, including cognitive impairment. However, cognitive impairment in CP - especially of a more subtle nature - is often overlooked, despite being associated with substantial academic, social, and emotional problems. In Denmark, the CP follow-up program (CPOP) includes systematic assessment of physical ...显示更多
官方标题
Cognitive Functioning in Children and Adolescents With Cerebral Palsy
疾病
脑瘫出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- CPCog-Youth-DK
- P-2023-155
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Case group Children and adolescents with cerebral palsy who are 11-15 years old, diagnosed with cerebral palsy (any type), and who attend a Danish mainstream school at time of enrollment | 认知评估 All participants will receive cognitive assessment with a core battery (CPCog) and a supplemental battery.
The core battery includes standardized tests of general cognitive functioning (intelligence) and visual-spatial abilities, as well as a questionnaire on executive functioning in daily life. The supplemental battery assesses attention, executive functioning, memory, fatigue, and symptoms of mental health issues ...显示更多 |
Control group Children and adolescents without cerebral palsy in the same age range as case-participants (11-15 years old) and attend Danish mainstream schools. | 认知评估 All participants will receive cognitive assessment with a core battery (CPCog) and a supplemental battery.
The core battery includes standardized tests of general cognitive functioning (intelligence) and visual-spatial abilities, as well as a questionnaire on executive functioning in daily life. The supplemental battery assesses attention, executive functioning, memory, fatigue, and symptoms of mental health issues ...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Global cognitive functioning (IQ) | General cognitive functioning as measured by the GAI from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) | At first day of assessment |
Visuo-spatial functioning | Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI) | At first day of assessment |
Executive functioning | Cognitive regulation index score from the Behavior Rating Inventory of Executive Function - second edition (BRIEF-2), parent version. | At first day of assessment |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Task switching ability | Number of correct words named on the D-KEFS verbal fluency task, and completion time in seconds on the D-KEFS Trail Making task | At second day of assessment |
Attention | Response sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.) | At second day of assessment |
Verbal memory | Scale scores of selected verbal subtests (Word Selective Reminding; Object Recall) from 6the Test of Memory and Learning, Second edition (TOMAL-2) | At second day of assessment |
Visual memory | Scale scores of selected nonverbal subtests (Abstract Visual Memory; Visual Sequential Memory) from the Test of Memory and Learning, Second Edition (TOMAL-2) | At second day of assessment |
Working memory | Working Memory Index score from the WISC-V | At second day of assessment |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
11 Years
适龄性别
全部
接受健康志愿者
是
- 11-15 years old
- Diagnosed with CP (irrespective of type and severity)
- Attends a Danish mainstream school at time of enrollment
- Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
CONTROL GROUP:
Inclusion Criteria:
- 11-15 years old
- Attends a Danish mainstream school at time of enrollment
Exclusion Criteria:
- Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
- Diagnosed with CP (irrespective of type and severity), traumatic brain injury or other neurological disorder (e.g., epilepsy)
Rigshospitalet, Denmark研究责任方
Camilla Funch Uhre, 主要研究者, MSc, PhD, Rigshospitalet, Denmark
研究中心联系人
联系人: Camilla Funch Uhre, MSc, PhD, +4530537166, [email protected]
联系人: Christina Høi-Hansen, MD, PhD, +4535455095, [email protected]
2 位于 1 个国家/地区的研究中心
Rigshospitalet, Copenhagen, 2100, Denmark
Camilla Funch Uhre, MSc, PhD, 联系人, +4530537166, [email protected]
Ida Dyhr Caspersen, MSc, PhD, 分研究者
招募中
Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Copenhagen, 2300, Denmark
Carsten Lose, MSc, 联系人, 61 96 83 07, [email protected]
招募中