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.
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.
Denmark2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Visuo-spatial functioning
Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)
Measured: 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.
Measured: At first day of assessment
Secondary outcomes (5)
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
Attention
Response sensitivity score (d') on the Test of Variables of Attention (T.O.V.A.)
Measured: At second day of assessment
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
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
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.
- First posted27 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Aarhus University Hospital, University of Copenhagen
- Responsible party
- Principal investigator, Camilla Funch Uhre, Copenhagen University Hospital, Rigshospitalet
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning in Children and Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05921422
- Acronym / sponsor ID
- CPCog-Youth-DK / P-2023-155
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Center for Rehabilitation of Brain Injury (Center for Hjerneskade), Aarhus University Hospital, University of Copenhagen
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Cognitive assessmentChildren 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 |
| Control group | – | Other: Cognitive assessmentChildren and adolescents without cerebral palsy in the same age range as case-participants (11-15 years old) and attend Danish mainstream schools. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and adolescents with cerebral palsy and healthy control participants (age range: 11-15 years old).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Does not speak or understand Danish at the level necessary to participate (as evaluated by the research team)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive assessmentAll 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). | Other | Case group, Control group |
Primary outcome
Global cognitive functioning (IQ)
Time frame: At first day of assessment
General cognitive functioning as measured by the GAI from the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)
Visuo-spatial functioning
Time frame: At first day of assessment
Score from the Beery-Buktenica Developmental Test of Visual Motor Integration (Beery VMI)
Executive functioning
Time frame: At first day of assessment
Cognitive regulation index score from the Behavior Rating Inventory of Executive Function - second edition (BRIEF-2), parent version.
5 secondary outcomes
Task switching ability
Time frame: At second day of assessment
Attention
Time frame: At second day of assessment
Verbal memory
Time frame: At second day of assessment
Visual memory
Time frame: At second day of assessment
Working memory
Time frame: At second day of assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Derived from this study: PubMed 39725891Uhre 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.