NCT04792606 Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy
| NCT ID | NCT04792606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2019-10-01 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Children with severe, non-ambulant (GMFCS IV \& V) Cerebral Palsy * between 2 and 19 years of age * with radiographic evidence of hip displacement (previously untreated) as measured by Reimer's MP ≥ 30% * and their parents or primary caregivers, defined as the individual most involved in the daily care of the child are willing to complete the CPCHILD in one of the available languages the CPCHILD is offered in Exclusion Criteria: * under the age of 2, or over the age of 19 * Reimer's migration percentage under 30% in both hips * parents or primary caregivers unable to complete the CPCHILD in one of it's available languages
Contact & Investigator
Unni G Narayanan
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT04792606 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 19 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04792606 currently recruiting?
Yes, NCT04792606 is actively recruiting participants. Contact the research team at unni.narayanan@sickkids.ca for enrollment information.
Where is the NCT04792606 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04792606 clinical trial?
NCT04792606 is sponsored by The Hospital for Sick Children. The principal investigator is Unni G Narayanan at The Hospital for Sick Children. The trial plans to enroll 1,000 participants.
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