Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy

NCT04792606 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2021-03-11

No results posted yet for this study

Summary

Children with severe cerebral palsy (CP) are at high risk for progressive hip displacement, associated with pain and contractures interfering with many aspects of care, comfort and quality of life. These children undergo many types of interventions, the optimal timing and effectiveness of which, remain unclear. In 2014, CIHR funded the CP Hip Outcomes Project (CHOP), an international multi-centre prospective longitudinal cohort study of children with severe (non-ambulant) CP with evidence of hip displacement defined as a Reimer's migration percentage (MP) of at least 30%. The study was designed to evaluate the comparative effectiveness of different treatment strategies to prevent or relieve symptoms associated with hip instability, using the validated Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD ) questionnaire as the primary outcome measure of health-related quality of life © (HRQL) for this population. 650 patients enrolled from 28 sites in 11 countries, are actively being followed and will reach at least 2 years of follow-up at the end of 2019. This project, will study the impact of hip instability and its management in children with severe CP using the CPCHILD questionnaire that was developed specifically for this purpose. Although CHOP will define outcomes at 24 months, the outcomes are not expected to remain stable while the child is still growing. The inception cohort will need follow-up until skeletal maturity to track their long-term outcome trajectories.

Conditions

  • Cerebral Palsy

Sponsors & Collaborators

  • Royal Children's Hospital

    collaborator OTHER
  • Shriners Hospitals for Children,Canada

    collaborator UNKNOWN
  • Provincial Health Services Authority

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Sheba Medical Center

    collaborator OTHER_GOV
  • Seoul National University Bundang Hospital

    collaborator OTHER
  • Starship Children's Hospital of New Zealand

    collaborator UNKNOWN
  • Poznan University of Medical Sciences

    collaborator OTHER
  • Skane University Hospital

    collaborator OTHER
  • Karolinska University Hospital

    collaborator OTHER
  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER
  • The Royal London Hospital

    collaborator UNKNOWN
  • Nuffield Orthopaedic Centre NHS Trust

    collaborator OTHER
  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER
  • Boston Children's Hospital

    collaborator OTHER
  • Columbia University

    collaborator OTHER
  • Shriners Hospitals for Children, Sacramento

    collaborator UNKNOWN
  • Gillette Children's Specialty Healthcare

    collaborator OTHER
  • Alfred I. duPont Hospital for Children

    collaborator OTHER
  • IWK Health Centre

    collaborator OTHER
  • Alder Hey Children's NHS Foundation Trust

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • Hospital for Special Surgery, New York

    collaborator OTHER
  • Shriners Hospitals for Children, Honolulu

    collaborator UNKNOWN
  • Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

    collaborator OTHER_GOV
  • Morgan Stanley Children's Hospital

    collaborator OTHER
  • Children's Health Queensland Hospital and Health Service

    collaborator UNKNOWN
  • University of Nebraska

    collaborator OTHER
  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Unni G Narayanan · The Hospital for Sick Children

Eligibility

Min Age
2 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2026-03-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04792606 on ClinicalTrials.gov