Cognitive Functioning in Children and Adolescents With Cerebral Palsy

NCT05921422 | Recruiting

• 1 other identifier: P-2023-155
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Task switching ability

  At second day of assessment

• Attention

  At second day of assessment

• Verbal memory

  At second day of assessment

• Visual memory

  At second day of assessment

• Working memory

  At second day of assessment

Other Outcomes (5)

• ADHD symptomatology

  At second day of assessment

• Symptoms of autism spectrum disorder

  At second day of assessment

• Symptoms of emotional behavioral disturbance

  At second day of assessment

Study Arms (2)

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

Other: Cognitive assessment

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.

Other: Cognitive assessment

Interventions

Cognitive assessment OTHER

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).

Case group; Control group

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with cerebral palsy and healthy control participants (age range: 11-15 years old).

You may qualify if:

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

You may not qualify if:

• \- Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
• CONTROL GROUP:
• years old
• 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)
• Diagnosed with CP (irrespective of type and severity), traumatic brain injury or other neurological disorder (e.g., epilepsy)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Center for Rehabilitation of Brain Injury (Center for Hjerneskade): collaborator
• Aarhus University Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Center for Rehabilitation of Brain Injury (Center for Hjerneskade)

Copenhagen, 2300, Denmark

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Camilla Funch Uhre, MSc, PhD

CONTACT

+4530537166; camilla.funch.uhre.01@regionh.dk

Christina Høi-Hansen, MD, PhD

CONTACT

+4535455095; christina.hoei-hansen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

DK (2)