Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CPCog-Youth-DK  

Official title:

Cognitive Functioning in Children and Adolescents With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921422
• Other study ID #: P-2023-155
• Status: Recruiting
• Start date: July 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Rigshospitalet, Denmark
• Contact: Camilla Funch Uhre, MSc, PhD
• Phone: +4530537166
• Email: camilla.funch.uhre.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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 disorder/ADHD).

Locations

Country	Name	City	State
Denmark	Center for Rehabilitation of Brain Injury (Center for Hjerneskade)	Copenhagen
Denmark	Rigshospitalet	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital, Center for Rehabilitation of Brain Injury (Center for Hjerneskade), University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ADHD symptomatology	Total scores of inattention, hyperactivity, and behavior scales of the ADHD-rs questionnaire	At second day of assessment
Other	Symptoms of autism spectrum disorder	Index score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version	At second day of assessment
Other	Symptoms of emotional behavioral disturbance	Index score from the Behavior Assessment System for Children, third edition (BASC-3), parent and child version	At second day of assessment
Other	Fatigue	PedsQL MFS score	At second day of assessment
Other	Adaptive functioning	General Adaptive Composite (GAC) score from the Adaptive Behavior Assessment System, Third Edition (ABAS-3)	At second day of assessment
Primary	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
Primary	Visuo-spatial functioning	Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)	At first day of assessment
Primary	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	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
Secondary	Attention	Response sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.)	At second day of assessment
Secondary	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
Secondary	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
Secondary	Working memory	Working Memory Index score from the WISC-V	At second day of assessment