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Идёт набор NCT05921422

Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Наблюдательное Cerebral Palsy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cognitive assessment.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy. Базовые параметры: 11 лет — 15 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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 functions, but cognitive assessment is omitted. Prior to starting school, professionals evaluate the school readiness of children with CP, sometimes including a test of general cognitive functioning. Thereafter, cognitive assessments are rarely offered in mainstream schools (Folkeskolen) and can only be accessed if the difficulties are clearly disabling. Recent studies indicate that cognitive assessment needs to be implemented in the follow-up program for school children. For example, one study found that only 42% of students with CP complete mainstream school in Denmark, and international neurocognitive studies have found global cognitive difficulties (lower IQ) and specific impairments in visuo-spatial functions, executive functions, and processing speed in youth with CP. User organizations in the Nordic countries have called for action in recent years, leading to the development of a proposed cognitive follow-up program for children and adolescents with CP, the CPCog, which has yet to be evaluated and implemented in Denmark. Taken together, prior studies and patient experiences emphasize the need for systematic assessment of cognitive functioning in children and adolescents with CP to document the type and extent of cognitive difficulties, secure qualified intervention, and prevent the development of social and emotional problems. Objective: The main purpose of this study is to characterize cognitive functioning in children and adolescents with CP in Danish mainstream schools. By documenting the extent and type of cognitive impairment associated with CP, we aim to inform future clinical practice and make recommendations for systematic assessment and intervention. Method: The study is a cross-sectional study with 100 children and adolescents with CP (11-15 years). Each participant will undergo cognitive assessment with the core battery proposed in the Nordic CPCog protocol, including assessment of general cognitive functioning (intelligence), executive functions, and visuo-motor skills. Additionally, participants will undergo supplemental tests of memory, attention, fatigue, and symptoms of psychopathology. Cognitive assessments will take place at two sites: the Neurocenter for Children and Adolescents, Center for Rehabilitation of Brain Injury, and the Center for Clinical Neuropsychology, Children and Adolescents, Rigshospitalet, Copenhagen, Denmark. The project is carried out in collaboration between the neuropediatric and neuropsychological teams associated with the two sites of assessment, as well as the Center for Cerebral Palsy, Rigshospitalet, Aarhus University Hospital, CPOP, and an external advisory board including leading international CP experts. Results: The CPCog-Youth-DK study will help characterize the cognitive difficulties associated with CP in children and adolescents in mainstream school, which will guide clinical practice and the development and implementation of systematic cognitive assessment and intervention programs. The cognitive assessment protocol will also be evaluated from the perspectives of children and adolescents with CP, parents, and professionals (e.g., assessors and school personnel) to evaluate whether the protocol is tolerable and helpful. Study results will be published in international, peer-reviewed journals, and will be made publicly available via other relevant platforms (such as the websites for the CP clinic at Rigshospitalet, Center for Rehabilitation of Brain Injury, and the Elsass Foundation). Several of the study investigators are directly involved in the current CP follow-up program in Denmark which will aid the process of turning our research into practice.

Вмешательства

  • Другое Cognitive assessment
    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 (including symptoms of anxiety, depression, and attention deficit hyperactivity

Первичные конечные точки

  • Global cognitive functioning (IQ) [Срок оценки: At first day of assessment]
  • Visuo-spatial functioning [Срок оценки: At first day of assessment]
  • Executive functioning [Срок оценки: At first day of assessment]
Вторичные конечные точки (5)
  • Task switching ability [Срок оценки: At second day of assessment]
  • Attention [Срок оценки: At second day of assessment]
  • Verbal memory [Срок оценки: At second day of assessment]
  • Visual memory [Срок оценки: At second day of assessment]
  • Working memory [Срок оценки: At second day of assessment]

Критерии участия

CASE GROUP:

Критерии включения

  • 11-15 years old
  • Diagnosed with CP (irrespective of type and severity)
  • Attends a Danish mainstream school at time of enrollment

Критерии исключения

\- Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)

CONTROL GROUP:

Критерии включения

  • 11-15 years old
  • Attends a Danish mainstream school at time of enrollment

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Дания · 2 центра
  • Rigshospitalet — Copenhagen
  • Center for Rehabilitation of Brain Injury (Center for Hjerneskade) — Copenhagen

Публикации

  • Uhre CF, Caspersen ID, Lose C, Rackauskaite G, Robotham R, Hoei-Hansen CE. Cognitive functioning in children and adolescents with cerebral palsy: protocol for the Danish CPCog-Youth study. BMC Pediatr. 2024 Dec 27;24(1):836. doi: 10.1186/s12887-024-05305-w. PMID 39725891

Идентификаторы

NCT: NCT05921422 · P-2023-155

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗