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Cerebral PalsyCPCog-Youth-DKNCT05921422

Cognitive Functioning in Children and Adolescents With Cerebral Palsy

An observational study of Cerebral Palsy, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 11 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Cerebral Palsy
What is being tested?
Cognitive assessment
How many people
150 participants
Where
2 sitesDenmark
Study dates
Jul 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

  • 11-15 years old
  • Diagnosed with CP (irrespective of type and severity)
  • Attends a Danish mainstream school at time of enrollment
  • 11-15 years old
  • Attends a Danish mainstream school at time of enrollment

Who cannot join

  • Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
  • CONTROL GROUP:
  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Denmark2 sites, 2 recruiting
  • Rigshospitalet

    Copenhagen, 2100

    Camilla Funch Uhre, MSc, PhD, +4530537166, camilla.funch.uhre.01@regionh.dk

    Ida Dyhr Caspersen, MSc, PhD

    Recruiting
  • Center for Rehabilitation of Brain Injury (Center for Hjerneskade)

    Copenhagen, 2300

    Carsten Lose, MSc, 61 96 83 07, carsten.lose@cfh.ku.dk

    Recruiting

Other trials in Denmark

About this study

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.

Read more

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
Being tested
Cognitive assessment
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive assessmentOther

    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).

Study groups in NCT05921422
Study groupRoleWhat they receive
Case groupChildren 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
Receives: Other: Cognitive assessment
Control groupChildren and adolescents without cerebral palsy in the same age range as case-participants (11-15 years old) and attend Danish mainstream schools.
Receives: Other: Cognitive assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global cognitive functioning (IQ)

    General cognitive functioning as measured by the GAI from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)

    Measured: At first day of assessment

  2. Visuo-spatial functioning

    Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)

    Measured: At first day of assessment

  3. Executive functioning

    Cognitive regulation index score from the Behavior Rating Inventory of Executive Function - second edition (BRIEF-2), parent version.

    Measured: At first day of assessment

Secondary outcomes (5)
  1. 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

    Measured: At second day of assessment

  2. Attention

    Response sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.)

    Measured: At second day of assessment

  3. Verbal memory

    Scale scores of selected verbal subtests (Word Selective Reminding; Object Recall) from 6the Test of Memory and Learning, Second edition (TOMAL-2)

    Measured: At second day of assessment

  4. 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)

    Measured: At second day of assessment

  5. Working memory

    Working Memory Index score from the WISC-V

    Measured: At second day of assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921422
Sponsor's protocol ID
P-2023-155
Acronym
CPCog-Youth-DK
Status last verified
Jun 2023
First submitted
19 Jun 2023
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39725891

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Camilla Funch Uhre, MSc, PhD (+4530537166, camilla.funch.uhre.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognitive functioning (IQ) (time frame: At first day of assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921422, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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