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Cognitive Functioning in Children and Adolescents With Cerebral Palsy (CPCog-Youth-DK) 150 International Pädiatrisch Jugendliche Akademisch

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05921422 (CPCog-Youth-DK) ist eine beobachtungsstudie zur Untersuchung von Zerebralparese und hat den Status offene rekrutierung. Die Studie startete am 1. Juli 2023 und soll 150 Teilnehmer aufnehmen. Durchgeführt von Rigshospitalet, Denmark ist der Abschluss für 1. Dezember 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. Juni 2023 aktualisiert.
Kurzbeschreibung
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 ...Mehr anzeigen
Offizieller Titel

Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Erkrankungen
Zerebralparese
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • CPCog-Youth-DK
  • P-2023-155
NCT-Nummer
NCT05921422
Studienbeginn (tatsächlich)
2023-07
Zuletzt aktualisiert
2023-06-27
Studienende (vorauss.)
2026-12
Geplante Rekrutierung
150
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
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
Kognitive Beurteilung
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 ...Mehr anzeigen
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.
Kognitive Beurteilung
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 ...Mehr anzeigen
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind
Mindestalter
11 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
CASE GROUP:
  • 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 logoRigshospitalet, Denmark
Verantwortliche Partei
Camilla Funch Uhre, Hauptprüfer, MSc, PhD, Rigshospitalet, Denmark
Zentrale Studienkontakte
Kontakt: Camilla Funch Uhre, MSc, PhD, +4530537166, [email protected]
Kontakt: Christina Høi-Hansen, MD, PhD, +4535455095, [email protected]
2 Studienstandorte in 1 Ländern
Rigshospitalet, Copenhagen, 2100, Denmark
Camilla Funch Uhre, MSc, PhD, Kontakt, +4530537166, [email protected]
Ida Dyhr Caspersen, MSc, PhD, Prüfarzt
Offene Rekrutierung
Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Copenhagen, 2300, Denmark
Carsten Lose, MSc, Kontakt, 61 96 83 07, [email protected]
Offene Rekrutierung