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

July 28, 2020 updated by: Mette Røn Kristensen

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.

Study Overview

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 Type

Observational

Enrollment (Anticipated)

957

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Region Hovedstaden
      • Hvidovre, Region Hovedstaden, Denmark, 2650
        • Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children registered in the Danish Cerebral Palsy Follow-up Program.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, on average 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between Gross Motor Function Classification System and Migrations Percentage (MP)
Time Frame: Through study completion, on average 3 years
Gross Motor Function Classification System and Migration Percentage
Through study completion, on average 3 years
Association between cerebral palsy subtype and Migrations Percentage
Time Frame: Through study completion, on average 3 years
cerebral palsy subtype and Migrations Percentage
Through study completion, on average 3 years
Association between standing position and Migrations Percentage
Time Frame: Through study completion, on average 3 years
Variables for standing position and Migrations Percentage
Through study completion, on average 3 years
Association between range of motion and Migrations Percentage
Time Frame: Through study completion, on average 3 years
range of motion (hip abduction, hip extension, hip external rotation, hamstrings length) and Migrations Percentage
Through study completion, on average 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mette Røn Kristensen, PT, MSc, Fysio- og Ergoterapien, afsnit 234-236, Hvidovre Hospital,

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

June 27, 2020

Study Completion (Anticipated)

December 27, 2020

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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