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El ensayo clínico NCT05921422 (CPCog-Youth-DK) para Parálisis cerebral está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Cognitive Functioning in Children and Adolescents With Cerebral Palsy (CPCog-Youth-DK) 150 Internacional Pediátrico Adolescentes Académico
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05921422 (CPCog-Youth-DK) es un estudio observacional para Parálisis cerebral. Su estado actual es: reclutando. El estudio se inició el 1 de julio de 2023, con el objetivo de reclutar a 150 participantes. Dirigido por Rigshospitalet, Denmark, se espera que finalice el 1 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de junio de 2023.
Resumen
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 ...Mostrar más
Título oficial
Cognitive Functioning in Children and Adolescents With Cerebral Palsy
Condiciones médicas
Parálisis cerebralPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- CPCog-Youth-DK
- P-2023-155
Número del NCT
Inicio del estudio (real)
2023-07
Última actualización
2023-06-27
Fecha de finalización (estimada)
2026-12
Inscripción (prevista)
150
Tipo de estudio
Observacional
Estado general
Reclutando
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
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 | Evaluación cognitiva 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 ...Mostrar más |
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. | Evaluación cognitiva 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 ...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
11 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- 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, DenmarkParte responsable del estudio
Camilla Funch Uhre, Investigador principal, MSc, PhD, Rigshospitalet, Denmark
Contactos centrales del estudio
Contacto: Camilla Funch Uhre, MSc, PhD, +4530537166, [email protected]
Contacto: Christina Høi-Hansen, MD, PhD, +4535455095, [email protected]
2 Centros del estudio en 1 países
Rigshospitalet, Copenhagen, 2100, Denmark
Camilla Funch Uhre, MSc, PhD, Contacto, +4530537166, [email protected]
Ida Dyhr Caspersen, MSc, PhD, Subinvestigador
Reclutando
Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Copenhagen, 2300, Denmark
Carsten Lose, MSc, Contacto, 61 96 83 07, [email protected]
Reclutando