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

Sponsor
Mette Røn Kristensen (Other)
Overall Status
Unknown status
CT.gov ID
NCT04398342
Collaborator
(none)
957
1
155.9
6.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    957 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Jun 27, 2020
    Anticipated Study Completion Date :
    Dec 27, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Children with Cerebral Palsy in Denmark

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

    Outcome Measures

    Primary Outcome Measures

    1. Characteristics for children with CP in Denmark [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.

    Secondary Outcome Measures

    1. Association between Gross Motor Function Classification System and Migrations Percentage (MP) [Through study completion, on average 3 years]

      Gross Motor Function Classification System and Migration Percentage

    2. Association between cerebral palsy subtype and Migrations Percentage [Through study completion, on average 3 years]

      cerebral palsy subtype and Migrations Percentage

    3. Association between standing position and Migrations Percentage [Through study completion, on average 3 years]

      Variables for standing position and Migrations Percentage

    4. Association between range of motion and Migrations Percentage [Through study completion, on average 3 years]

      range of motion (hip abduction, hip extension, hip external rotation, hamstrings length) and Migrations Percentage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Months to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital Hvidovre Region Hovedstaden Denmark 2650

    Sponsors and Collaborators

    • Mette Røn Kristensen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mette Røn Kristensen, Regional coordinator for CPOP in the capital region of Denmark, Hvidovre University Hospital
    ClinicalTrials.gov Identifier:
    NCT04398342
    Other Study ID Numbers:
    • P-2019-143 1
    First Posted:
    May 21, 2020
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2020