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Cohort of Children With Severe Cerebral Palsy (CPCohort)

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ClinicalTrials.gov Identifier: NCT01840930
Recruitment Status : Recruiting
First Posted : April 26, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

" 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 2016. 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.


Condition or disease
Orthopedic Complications in Cerebral Palsy

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Study Type : Observational
Estimated Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of a Children Population With Bilateral Severe Cerebral Palsy: Incidence and Evolution of Orthopaedic Complications and Pain Related With These Complications.
Study Start Date : September 2009
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.




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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840930


Contacts
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Contact: Isabelle POIROT, PhD 4 78 86 16 64 ext +33 isabelle.poirot@chu-lyon.fr
Contact: Valérie LAUDY 4 72 35 75 51 ext +33 valerie.laudy@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Hôpital Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Isabelle POIROT, PhD    4 78 86 16 64 ext +33    isabelle.poirot@chu-lyon.fr   
Contact: Valérie LAUDY    4 72 35 75 51 ext +33    valerie.laudy@chu-lyon.fr   
Principal Investigator: Isabelle POIROT, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Isabelle POIROT, PhD Hospices Civils de Lyon - Hôpital Femme Mère Enfant

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01840930     History of Changes
Other Study ID Numbers: D50687
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Hospices Civils de Lyon:
Cohort
Cerebral Palsy
Children
Pain
Orthopedic complications
Epidemiology

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases