Cohort of Children With Severe Cerebral Palsy (CPCohort)

January 14, 2020 updated by: Hospices Civils de Lyon

Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.

" Cohort CP " is a multicentre cohort study, initiated by the Hospices Civils de Lyon in September 2009. Population targeted are children with bilateral cerebral palsy, level GMFCS IV or V, aged from 2 to 10 years at inclusion. They are followed-up during 10 years, at the rhythm of 1 visit per year. At each visit are collected clinical, orthopaedic, radiological and environmental data.

The primary objective is to establish the incidence of orthopaedic complications (scoliosis and hip joint) depending on patients' age.

Secondary objectives are to describe the sequences over time of these complications and the related pain, to explore the impact of nutrition, surgery, asymmetric postures and environmental factors, and to describe the medical and rehabilitative follow-up of these patients.

385 patients are expected by the end of 2020. We expect of this long-term follow-up to gain tools that permit to improve patient's care and patient's quality of life, by putting in place preventing actions and adapted treatments related to their own pathologies.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

385

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Hospices Civils de Lyon - Hôpital Femme Mère Enfant
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabelle POIROT, PhD

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

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children aged from 2 to 10 years, with severe cerebral palsy: who do not acquire the ability to walk.

Description

Inclusion Criteria:

  • Children aged from 2 to 10 years at inclusion,
  • with bilateral cerebral palsy,
  • Grade IV or V of the GMFCS.
  • Affiliated with the French healthcare system.
  • Oral consent of the parents obtained.

Exclusion Criteria:

- Progressive pathology.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of hip migration (%) and/or scoliosis (Cobb angle) during the 10 years of patients' follow-up.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10

Hip migration is measured in percentage (Rimers method), and scoliosis is measured in degrees (Cobb angle).

For the first visit (A00= inclusion), if hip migration measured on the last radiography is ≥ 20%, it is asked to trace the history of the migration with measurements of previous patient's radiographies. For this first visit, if the Cobb angle on the last radiography is ≥ 20°, it is also asked to trace history of scoliosis with previous radiographies.

For the following visits (A01 to A10), only the last radiography is required for each year.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of nutrition on the occurrence of orthopedic complications and related pain.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Occurrence of hip migration or scoliosis correlated with annual measurement of nutritional state. Nutritional state is measured by weight, size, skinfold, and description of alimentation mode.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of surgical treatment of hip luxation on pain.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Subjects split into 2 groups: pain / without pain; comparison of percentages of children operated into each group.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Impact of asymmetric postures on the occurrence of orthopedic complications and related pain.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Frequency of windswept attitude function of type of bearings and postures.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between neurological asymmetry and windswept and/or hip joint.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Frequency of neurological asymmetry function of windswept laterality and/or hip joint.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Relationship between environmental factors and orthopedic complications, pain, and nutrition.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Correlation between patient's environment, hip migration and scoliosis, pain and nutrition.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the rehabilitative and medical follow-up in the studied population.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Recording of the main steps of medical and rehabilitative care received by each patient.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10
Description of the sequences over time of orthopedic complications and the related pain.
Time Frame: Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10

Pattern of individual evolution of pain function of age, and quantification of orthopedic surgery impact on pain evolution.

Pain is measured with the DESS scale (Douleur Enfant San Salvadour) for children with no oral language, or with the VAS (Visual Analogue Scale) for children who have an oral language. In addition, the location, the frequency and the length of time of the related pain are recorded on the Case Report Form.
Day 0, year 1, year 2, year 3, year 4, year 5, year 6, year 7, year 8, year 9, year 10

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Isabelle POIROT, PhD, Hospices Civils de Lyon - Hôpital Femme Mère Enfant

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)

September 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2030

Study Completion (ANTICIPATED)

December 1, 2030

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (ESTIMATE)

April 26, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D50687

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.

Clinical Trials on Orthopedic Complications in Cerebral Palsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe