NCT04792606

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Oct 2019Mar 2028

Study Start

First participant enrolled

October 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

6.5 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)

    The CPCHILD questionnaire is intended for persons with CP who rely on a wheelchair for most of their mobility. The CPCHILD questionnaire assesses how parents or caregivers rate their child (or how a child rates him/herself when able) about various issues related to daily activities, self care, getting around, comfort, communication, social interaction and health. The CPCHILD also identifies which of these issues the parents (or the child) feel are important to improve.

    The CPCHILD takes approximately 15 minutes to complete

Study Arms (5)

"Natural" History or watchful waiting

Serial botulinum toxin injections

Adductor (+/- psoas) muscle releases alone

Hip reconstructive surgery

Salvage hip surgery

Eligibility Criteria

Age2 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children between the ages of 2 and 19 with severe cerebral palsy (defined as a GMFCS level or IV or V) experiencing hip displacement (with radiographic evidence of a migration percentage (MP) or 30%) will be recruited to be apart of the CHOP II study.

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Unni G Narayanan

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Unni G Narayanan, MD

CONTACT

416-813-6432unni.narayanan@sickkids.ca

Ashley Ferkul

CONTACT

416-813-6608ashley.ferkul@sickkids.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS, MSc, FRSC(C)

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

October 1, 2019

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2028

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)