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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04398342
• Other study ID #: P-2019-143 1
• Status: Enrolling by invitation
• Start date: January 1, 2008
• Est. completion date: December 27, 2020

Study information

• Verified date: July 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 957
• Est. completion date: December 27, 2020
• Est. primary completion date: June 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Child
• Hip Dislocation
• Hip Displacement
• Orthopedic
• Paralysis
• Radiography
• Registries

Locations

Country	Name	City	State
Denmark	Fysio- og Ergoterapien, afsnit 234-236, Hvidovre hospital	Hvidovre	Region Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Mette Røn Kristensen

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Hägglund 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. — View Citation

Rasmussen HM, Nordbye-Nielsen K, Møller-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. eCollection 2016. Review. — View Citation

Outcome

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