NCT04398342

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
957

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

12.5 years

First QC Date

May 15, 2020

Last Update Submit

July 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Association between Gross Motor Function Classification System and Migrations Percentage (MP)

    Through study completion, on average 3 years

  • Association between cerebral palsy subtype and Migrations Percentage

    Through study completion, on average 3 years

  • Association between standing position and Migrations Percentage

    Through study completion, on average 3 years

  • Association between range of motion and Migrations Percentage

    Through study completion, on average 3 years

Study Arms (1)

Children with Cerebral Palsy in Denmark

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

Eligibility Criteria

Age4 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \- Cerebral palsy diagnosis was not confirmed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 27822084BACKGROUND
  • 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.

    PMID: 25371472BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHip Dislocation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Mette Røn Kristensen, PT, MSc

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Regional coordinator for CPOP in the capital region of Denmark

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 21, 2020

Study Start

January 1, 2008

Primary Completion

June 27, 2020

Study Completion

December 27, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations