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Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05921422
Acronym
CPCog-Youth-DK
Enrollment
150
Registered
2023-06-27
Start date
2023-07-31
Completion date
2026-12-31
Last updated
2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Brief summary

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.

Interventions

OTHERCognitive 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 disorder/ADHD).

Sponsors

Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
CollaboratorUNKNOWN
Aarhus University Hospital
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
Yes

Inclusion criteria

CASE GROUP: Inclusion Criteria: * 11-15 years old * Diagnosed with CP (irrespective of type and severity) * 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) CONTROL GROUP: Inclusion Criteria: * 11-15 years old * Attends a Danish mainstream school at time of enrollment

Design outcomes

Primary

MeasureTime frameDescription
Global cognitive functioning (IQ)At first day of assessmentGeneral cognitive functioning as measured by the GAI from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Executive functioningAt first day of assessmentCognitive regulation index score from the Behavior Rating Inventory of Executive Function - second edition (BRIEF-2), parent version.
Visuo-spatial functioningAt first day of assessmentScore from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)

Secondary

MeasureTime frameDescription
AttentionAt second day of assessmentResponse sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.)
Task switching abilityAt second day of assessmentNumber of correct words named on the D-KEFS verbal fluency task, and completion time in seconds on the D-KEFS Trail Making task
Verbal memoryAt second day of assessmentScale scores of selected verbal subtests (Word Selective Reminding; Object Recall) from 6the Test of Memory and Learning, Second edition (TOMAL-2)
Visual memoryAt second day of assessmentScale scores of selected nonverbal subtests (Abstract Visual Memory; Visual Sequential Memory) from the Test of Memory and Learning, Second Edition (TOMAL-2)
Working memoryAt second day of assessmentWorking Memory Index score from the WISC-V

Other

MeasureTime frameDescription
Symptoms of emotional behavioral disturbanceAt second day of assessmentIndex score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version
Adaptive functioningAt second day of assessmentGeneral Adaptive Composite (GAC) score from the Adaptive Behavior Assessment System, Third Edition (ABAS-3)
Symptoms of autism spectrum disorderAt second day of assessmentIndex score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version
ADHD symptomatologyAt second day of assessmentTotal scores of inattention, hyperactivity, and behavior scales of the ADHD-rs questionnaire
FatigueAt second day of assessmentPedsQL MFS score

Countries

Denmark

Contacts

Primary ContactCamilla Funch Uhre, MSc, PhD
camilla.funch.uhre.01@regionh.dk+4530537166
Backup ContactChristina Høi-Hansen, MD, PhD
christina.hoei-hansen@regionh.dk+4535455095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026