Recruiting

Hip Interventions

Sponsor:

The Hospital for Sick Children

Code:

NCT04792606

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 2 - 19

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cerebral Palsy

Study ID

NCT04792606

Start date

Oct 1, 2019

Status verified date

Mar, 2021

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 19

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

"Natural" History or watchful waiting

Serial botulinum toxin injections

Adductor (+/- psoas) muscle releases alone

Hip reconstructive surgery

Salvage hip surgery

Primary outcome measure

  • Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) [ Time Frame: The CPCHILD takes approximately 15 minutes to complete ]

Central Contacts and Locations

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Principal Investigator:

Unni G Narayanan, MBBS, MSc, FRCSC

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Mar 11, 2021

Last verified

Mar, 2021

Keywords

  • non-ambulatory, non-ambulatory cerebral palsy, patient reported outcomes measures, PROMS, outcomes, CPCHILD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2021-03-11.