Characteristics of Children With Cerebral Palsy Who Develops Hip Displacement in Denmark

NCT ID: NCT04398342

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-01

Study Completion Date

2020-12-27

Brief Summary

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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

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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

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Cerebral Palsy Hip Displacement Hip Dislocation Child Registries Orthopedic Radiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with Cerebral Palsy in Denmark

Children diagnosed with cerebral palsy born 2003 - 2020 and registered in the Danish Cerebral Palsy Follow-up Program.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children diagnosed with CP born 2003 - 2020
* Classified at Gross Motor Function Classification Level I to V
* Minimum one radiographic examination of the hips.

Exclusion Criteria

\- Cerebral palsy diagnosis was not confirmed.
Minimum Eligible Age

4 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mette Røn Kristensen

OTHER

Sponsor Role lead

Responsible Party

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Mette Røn Kristensen

Regional coordinator for CPOP in the capital region of Denmark

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mette Røn Kristensen, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Fysio- og Ergoterapien, afsnit 234-236, Hvidovre Hospital,

Locations

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Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital

Hvidovre, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 27822084 (View on PubMed)

Hagglund 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.

Reference Type BACKGROUND
PMID: 25371472 (View on PubMed)

Other Identifiers

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P-2019-143 1

Identifier Type: -

Identifier Source: org_study_id

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