Cerebral PalsyNCT04398342
Characteristics of Children With Cerebral Palsy Who Develops Hip Displacement in Denmark
An observational study of Cerebral Palsy and Hip Displacement, run by Mette Røn Kristensen at 1 site in Denmark.
Trial summary
The aim is to describe the characteristics of children with cerebral palsy in Denmark. Furthermore, we want to focus on status of the children's hips. Read more about this study
- Who is it for?
- Ages 4 months to 18 years
- Conditions the study is for
- Cerebral Palsy, Hip Displacement, Hip Dislocation
- How many people
- 957 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2008to 27 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children registered in the Danish Cerebral Palsy Follow-up Program.
Who may be able to join
- Children diagnosed with CP born 2003 - 2020
- Classified at Gross Motor Function Classification Level I to V
- Minimum one radiographic examination of the hips.
Who cannot join
- Cerebral palsy diagnosis was not confirmed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital
Hvidovre, Capital Region, 2650
About this study
Official title: A Descriptive Study of Children With Cerebral Palsy Participating in The Danish Cerebral Palsy Follow-Up Program, With Emphasis on Their Hip Status
The aim is to describe the characteristics of children with cerebral palsy in Denmark. Furthermore, we want to focus on status of the children's hips.
Read the detailed description
Introduction: In 1994, a surveillance programme for children with Cerebral Palsy called the Cerebral Palsy Follow-Up Programme (CPUP) was established in Sweden with the primary purpose of preventing hip dislocation.
Hip dislocation is a serious complication to cerebral palsy, which is very painful for the child and requires complex hip surgery. Research studies have documented the effects of the follow-up program on the prevention of dislocation of the hip in children with CP in Sweden.
In 2003, the region of Southern Denmark introduced the Swedish follow-up program with the Danish name Cerebral Palsy Follow-up Program (CPOP). CPOP has since become a national follow-up program as well as a national clinical quality database in Denmark that includes children with CP aged 0-15 years and children with cerebral palsy-like symptoms aged 0-5 (5). The objective of the CPOP is to prevent complications associated with CP such as hip dislocation, scoliosis and contractures of muscles and joints.
It is now ten years since the first children were included in CPOP. There is no report describing the characteristics of children with cerebral palsy in Denmark and the status of the primary aim of the programme, hip status.
This study includes children diagnosed with CP born 2003 - 2020 and registered in the Danish Cerebral Palsy Follow-up Program.
Variables that will be analyzed are:
- age,
- Gross Motor Function Classification System Level I-V
- cerebral palsy subtype,
- Acetabular index,
- standing function,
- range of motion (hip abduction, hip extension, hip external rotation, hamstrings length)
- Modified Ashworth Scale (hip adduction, hip flexion, knee extension)
- Functional Mobility Scare (FMS)
- Gross Motor Function Measure (GMFM)
- hip displacement. Hip displacement is measured using divided into three categories; MP < 33 %, MP > 33-39 % og MP > 40 % with an extra category MP 100% describing children with hip dislocation.
- hip surgery. Categorized as; 1) soft tissue surgery, 2) neurosurgical procedures 3) osseous procedures.
Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
Variables will be summarize by counts, proportions and/or percentages using graphs and tables. Furthermore, the median and interquartile range will be specified when meaningful. Additionally, we will do non-parametric statistics (significance tests).
Currently, we do not have information about the extent of missing data for the different variables. When we have obtained the data, we will determine whether we have sufficient completeness for these variables to be included and reported in the statistical significance tests.
- Conditions
- Cerebral Palsy, Hip Displacement, Hip Dislocation, Child, Registries, Orthopedic
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cerebral Palsy in Denmark | Children diagnosed with cerebral palsy born 2003 - 2020 and registered in the Danish Cerebral Palsy Follow-up Program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics for children with CP in Denmark
Age, Gross Motor Function Classification Level (I-V), cerebral palsy subtype, acetabular index, standing function, Functional Mobility Scale, Gross Motor Function Measure, range of motion (hip abduction, hip extension, hip external rotation, hamstrings length), Modified Ashworth Scale (hip adduction, hip flexion, knee extension), hip displacement ( Migration Percentage) and hip surgery.
Measured: Through study completion, on average 3 years
Secondary outcomes (4)
Association between Gross Motor Function Classification System and Migrations Percentage (MP)
Gross Motor Function Classification System and Migration Percentage
Measured: Through study completion, on average 3 years
Association between cerebral palsy subtype and Migrations Percentage
cerebral palsy subtype and Migrations Percentage
Measured: Through study completion, on average 3 years
Association between standing position and Migrations Percentage
Variables for standing position and Migrations Percentage
Measured: Through study completion, on average 3 years
Association between range of motion and Migrations Percentage
range of motion (hip abduction, hip extension, hip external rotation, hamstrings length) and Migrations Percentage
Measured: Through study completion, on average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jan 2008
- Primary completion27 Jun 2020
- Study completion27 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 957 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Røn Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mette Røn Kristensen, Hvidovre University Hospital
- Investigators
- Mette Røn Kristensen, PT, MSc, Principal investigator, Fysio- og Ergoterapien, afsnit 234-236, Hvidovre Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398342
- Sponsor's protocol ID
- P-2019-143 1
- Status last verified
- Jul 2020
- First submitted
- 15 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.
PubMed 27822084Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
PubMed 25371472
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of Children With Cerebral Palsy Participating in The Danish Cerebral Palsy Follow-Up Program, With Emphasis on Their Hip Status
- ClinicalTrials.gov ID
- NCT04398342
- Acronym / sponsor ID
- P-2019-143 1
- Conditions
- Cerebral Palsy, Hip Displacement, Hip Dislocation, Child, Registries, Orthopedic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 957 participants (estimated)
- Lead sponsor
- Mette Røn KristensenUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 27 Jun 2020 (actual)
- Study completion
- 27 Dec 2020 (estimated)
- First posted
- 21 May 2020 (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.
The aim is to describe the characteristics of children with cerebral palsy in Denmark. Furthermore, we want to focus on status of the children's hips.
Detailed description
Introduction: In 1994, a surveillance programme for children with Cerebral Palsy called the Cerebral Palsy Follow-Up Programme (CPUP) was established in Sweden with the primary purpose of preventing hip dislocation.
Hip dislocation is a serious complication to cerebral palsy, which is very painful for the child and requires complex hip surgery. Research studies have documented the effects of the follow-up program on the prevention of dislocation of the hip in children with CP in Sweden.
In 2003, the region of Southern Denmark introduced the Swedish follow-up program with the Danish name Cerebral Palsy Follow-up Program (CPOP). CPOP has since become a national follow-up program as well as a national clinical quality database in Denmark that includes children with CP aged 0-15 years and children with cerebral palsy-like symptoms aged 0-5 (5). The objective of the CPOP is to prevent complications associated with CP such as hip dislocation, scoliosis and contractures of muscles and joints.
It is now ten years since the first children were included in CPOP. There is no report describing the characteristics of children with cerebral palsy in Denmark and the status of the primary aim of the programme, hip status.
This study includes children diagnosed with CP born 2003 - 2020 and registered in the Danish Cerebral Palsy Follow-up Program.
Variables that will be analyzed are:
- age,
- Gross Motor Function Classification System Level I-V
- cerebral palsy subtype,
- Acetabular index,
- standing function,
- range of motion (hip abduction, hip extension, hip external rotation, hamstrings length)
- Modified Ashworth Scale (hip adduction, hip flexion, knee extension)
- Functional Mobility Scare (FMS)
- Gross Motor Function Measure (GMFM)
- hip displacement. Hip displacement is measured using divided into three categories; MP < 33 %, MP > 33-39 % og MP > 40 % with an extra category MP 100% describing children with hip dislocation.
- hip surgery. Categorized as; 1) soft tissue surgery, 2) neurosurgical procedures 3) osseous procedures.
Data will be obtained from the national clinical quality database the Danish Cerebral Palsy Follow-up Program and the Danish National Patient Register.
Variables will be summarize by counts, proportions and/or percentages using graphs and tables. Furthermore, the median and interquartile range will be specified when meaningful. Additionally, we will do non-parametric statistics (significance tests).
Currently, we do not have information about the extent of missing data for the different variables. When we have obtained the data, we will determine whether we have sufficient completeness for these variables to be included and reported in the statistical significance tests.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cerebral Palsy in Denmark | – | –Children diagnosed with cerebral palsy born 2003 - 2020 and registered in the Danish Cerebral Palsy Follow-up Program. |
Who may qualify
- Ages
- 4 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children registered in the Danish Cerebral Palsy Follow-up Program.
Key inclusion criteria (3 listed)
- Children diagnosed with CP born 2003 - 2020
- Classified at Gross Motor Function Classification Level I to V
- Minimum one radiographic examination of the hips.
Key exclusion criteria (1 listed)
- Cerebral palsy diagnosis was not confirmed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics for children with CP in Denmark
Time frame: Through study completion, on average 3 years
Age, Gross Motor Function Classification Level (I-V), cerebral palsy subtype, acetabular index, standing function, Functional Mobility Scale, Gross Motor Function Measure, range of motion (hip abduction, hip extension, hip external rotation, hamstrings length), Modified Ashworth Scale (hip adduction, hip flexion, knee extension), hip displacement ( Migration Percentage) and hip surgery.
4 secondary outcomes
Association between Gross Motor Function Classification System and Migrations Percentage (MP)
Time frame: Through study completion, on average 3 years
Association between cerebral palsy subtype and Migrations Percentage
Time frame: Through study completion, on average 3 years
Association between standing position and Migrations Percentage
Time frame: Through study completion, on average 3 years
Association between range of motion and Migrations Percentage
Time frame: Through study completion, on average 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Background: PubMed 27822084Rasmussen HM, Nordbye-Nielsen K, Moller-Madsen B, Johansen M, Ellitsgaard N, Pedersen CR, Rackauskaite G, Engberg H, Pedersen NW. The Danish Cerebral Palsy Follow-up Program. Clin Epidemiol. 2016 Oct 25;8:457-460. doi: 10.2147/CLEP.S99474. eCollection 2016.
- Background: PubMed 25371472Hagglund G, Alriksson-Schmidt A, Lauge-Pedersen H, Rodby-Bousquet E, Wagner P, Westbom L. Prevention of dislocation of the hip in children with cerebral palsy: 20-year results of a population-based prevention programme. Bone Joint J. 2014 Nov;96-B(11):1546-52. doi: 10.1302/0301-620X.96B11.34385.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mette Røn Kristensen, PT, MSc principal investigator
Fysio- og Ergoterapien, afsnit 234-236, Hvidovre Hospital,
1 site 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 and Hip Displacement, run by Mette Røn Kristensen at 1 site 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics for children with CP in Denmark (time frame: Through study completion, on average 3 years). 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 NCT04398342, which also lists 2 linked publications.
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 29 Jul 2020.