Long-term outcomes of hip interventions for children with cerebral palsy
Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-Centre Prospective Comparative Cohort Study (CHOP-II)
The Hospital for Sick Children · NCT04792606
This study looks at different treatments for hip problems in children with severe cerebral palsy to see how they can improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 2 Years to 19 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04792606 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with severe, non-ambulant cerebral palsy who are at risk for hip displacement, which can lead to pain and reduced quality of life. It aims to evaluate the effectiveness of various treatment strategies to manage hip instability by following a cohort of 650 patients across 28 sites in 11 countries. The primary outcome measure is the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire, which assesses health-related quality of life. The study will provide insights into the optimal timing and effectiveness of interventions for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 19 years with severe, non-ambulant cerebral palsy and untreated hip displacement.
Not a fit: Patients under 2 years or over 19 years of age, or those with a Reimer's migration percentage under 30% in both hips, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of hip instability in children with cerebral palsy, enhancing their quality of life.
How similar studies have performed: Other studies have shown success in evaluating treatment strategies for hip instability in similar populations, but this study's scale and design are unique.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Unni G Narayanan — The Hospital for Sick Children
- Study coordinator: Unni G Narayanan, MD
- Email: unni.narayanan@sickkids.ca
- Phone: 416-813-6432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy, non-ambulatory, non-ambulatory cerebral palsy, patient reported outcomes measures, PROMS, outcomes, CPCHILD