Clinical trial NCT05921422: Cognitive Functioning in Children and Adolescents With Cerebral Palsy
Official title: Cognitive Functioning in Children and Adolescents With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
name: Aarhus University Hospital
name: University of Copenhagen
First posted: 2023-06-27
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with cerebral palsy and healthy control participants (age range: 11-15 years old).

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.


Eligibility 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

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)

Primary outcomes:
measure: Global cognitive functioning (IQ)
timeFrame: At first day of assessment
measure: Visuo-spatial functioning
timeFrame: At first day of assessment
measure: Executive functioning
timeFrame: At first day of assessment
Secondary outcomes:
measure: Task switching ability
timeFrame: At second day of assessment
measure: Attention
timeFrame: At second day of assessment
measure: Verbal memory
timeFrame: At second day of assessment
measure: Visual memory
timeFrame: At second day of assessment
measure: Working memory
timeFrame: At second day of assessment
Other outcomes:
measure: ADHD symptomatology
timeFrame: At second day of assessment
measure: Symptoms of autism spectrum disorder
timeFrame: At second day of assessment
measure: Symptoms of emotional behavioral disturbance
timeFrame: At second day of assessment
measure: Fatigue
timeFrame: At second day of assessment
measure: Adaptive functioning
timeFrame: At second day of assessment
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Center for Rehabilitation of Brain Injury (Center for Hjerneskade)
Study officials:
References: