Cerebral PalsyCHOP IINCT04792606
Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 19 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Unni G Narayanan, MD, 416 813 6432, unni.narayanan@sickkids.ca
Ashley Ferkul, BA, 416-813-6608, ashley.ferkul@sickkids.ca
About this study
Official title: Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-Centre Prospective Comparative Cohort Study (CHOP-II)
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.
Read the detailed description
Background: 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, unique in scale and design, will study the impact of hip instability and its management in children with severe CP using a meaningful outcome measure 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. The international network of investigators/sites and the infrastructure established for CHOP will facilitate the long-term follow-up of the participants in this study. In addition, the results of CHOP will inform the design of nested trials to evaluate the effectiveness of future interventions aimed at improving the quality of life of children with severe disabilities.
Study Aims Aim 1: Measure the post 24-month effectiveness of different treatment strategies for hip displacement in children with severe CP using the CPCHILD as the primary outcome measure.
Aim 2: Compare the rates of recurrence, relapse of symptoms, additional interventions and other longer term complications associated with each of the treatment cohorts.
Methods
Study Design: Multi-centre longitudinal cohort study of children with severe (non-ambulant) CP, ages 3 to 18 years with hip MP ≥ 30% enrolled in one of 5 cohorts:
- "Natural" History or watchful waiting B. Serial botulinum toxin injections C. Adductor (+/- psoas) muscle releases alone D. Hip reconstructive surgery E. Salvage hip surgery Data collected include demographics, prognostic factors, including co-morbid conditions, parental reports of HRQL as measured by the CPCHILD, and radiographic measures of MP and acetabular index (AI). The primary outcome measure CPCHILD, as well as the MP \& AI will be assessed every 12 months after the 24 month follow-up since inception in CHOP. The cohort of 650 children enrolled in Groups B, C, D, \& E will be compared with each other as well as with their respective propensity matched counterparts of untreated children (Group A), using repeated measures ANOCOVA at 3yrs, and annually thereafter until at least 5 years of follow-up or skeletal maturity.
Significance: CHOP I \& II will establish the superiority of either prophylactic or reactive intervention strategies for hip displacement in severe CP and provide justification for hip surveillance.
- Conditions
- Cerebral Palsy
- Keywords
- non-ambulatory, non-ambulatory cerebral palsy, patient reported outcomes measures, PROMS, outcomes, CPCHILD
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "Natural" History or watchful waiting | Not described | |
| Serial botulinum toxin injections | Not described | |
| Adductor (+/- psoas) muscle releases alone | Not described | |
| Hip reconstructive surgery | Not described | |
| Salvage hip surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The CPCHILD takes approximately 15 minutes to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Oct 2019
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital, Shriners Hospitals for Children,Canada, Provincial Health Services Authority British Columbia, Aarhus University Hospital, Sheba Medical Center, Seoul National University Bundang Hospital, Starship Children's Hospital of New Zealand, Poznan University of Medical Sciences, Skane University Hospital, Karolinska University Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, The Royal London Hospital, Nuffield Orthopaedic Centre NHS Trust, Children's Hospital Medical Center, Cincinnati, Boston Children's Hospital, Columbia University, Shriners Hospitals for Children, Sacramento, Gillette Children's Specialty Healthcare, Alfred I. duPont Hospital for Children, IWK Health Centre, Alder Hey Children's NHS Foundation Trust, Children's Hospital Colorado, Hospital for Special Surgery, New York, Shriners Hospitals for Children, Honolulu, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Morgan Stanley Children's Hospital, Children's Health Queensland Hospital and Health Service, University of Nebraska
- Responsible party
- Principal investigator, Unni Narayanan, The Hospital for Sick Children
- Investigators
- Unni G Narayanan, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792606
- Sponsor's protocol ID
- 420492
- Acronym
- CHOP II
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-Centre Prospective Comparative Cohort Study (CHOP-II)
- ClinicalTrials.gov ID
- NCT04792606
- Acronym / sponsor ID
- CHOP II / 420492
- Conditions
- Cerebral Palsy
- Keywords
- non-ambulatory, non-ambulatory cerebral palsy, patient reported outcomes measures, PROMS, outcomes, CPCHILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Royal Children's Hospital, Shriners Hospitals for Children,Canada, Provincial Health Services Authority British Columbia, Aarhus University Hospital, Sheba Medical Center, Seoul National University Bundang Hospital, Starship Children's Hospital of New Zealand, Poznan University of Medical Sciences, Skane University Hospital, Karolinska University Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust, The Royal London Hospital, Nuffield Orthopaedic Centre NHS Trust, Children's Hospital Medical Center, Cincinnati, Boston Children's Hospital, Columbia University, Shriners Hospitals for Children, Sacramento, Gillette Children's Specialty Healthcare, Alfred I. duPont Hospital for Children, IWK Health Centre, Alder Hey Children's NHS Foundation Trust, Children's Hospital Colorado, Hospital for Special Surgery, New York, Shriners Hospitals for Children, Honolulu, Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Morgan Stanley Children's Hospital, Children's Health Queensland Hospital and Health Service, University of Nebraska
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: 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, unique in scale and design, will study the impact of hip instability and its management in children with severe CP using a meaningful outcome measure 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. The international network of investigators/sites and the infrastructure established for CHOP will facilitate the long-term follow-up of the participants in this study. In addition, the results of CHOP will inform the design of nested trials to evaluate the effectiveness of future interventions aimed at improving the quality of life of children with severe disabilities.
Study Aims Aim 1: Measure the post 24-month effectiveness of different treatment strategies for hip displacement in children with severe CP using the CPCHILD as the primary outcome measure.
Aim 2: Compare the rates of recurrence, relapse of symptoms, additional interventions and other longer term complications associated with each of the treatment cohorts.
Methods
Study Design: Multi-centre longitudinal cohort study of children with severe (non-ambulant) CP, ages 3 to 18 years with hip MP ≥ 30% enrolled in one of 5 cohorts:
- "Natural" History or watchful waiting B. Serial botulinum toxin injections C. Adductor (+/- psoas) muscle releases alone D. Hip reconstructive surgery E. Salvage hip surgery Data collected include demographics, prognostic factors, including co-morbid conditions, parental reports of HRQL as measured by the CPCHILD, and radiographic measures of MP and acetabular index (AI). The primary outcome measure CPCHILD, as well as the MP \& AI will be assessed every 12 months after the 24 month follow-up since inception in CHOP. The cohort of 650 children enrolled in Groups B, C, D, \& E will be compared with each other as well as with their respective propensity matched counterparts of untreated children (Group A), using repeated measures ANOCOVA at 3yrs, and annually thereafter until at least 5 years of follow-up or skeletal maturity.
Significance: CHOP I \& II will establish the superiority of either prophylactic or reactive intervention strategies for hip displacement in severe CP and provide justification for hip surveillance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| "Natural" History or watchful waiting | – | – |
| Serial botulinum toxin injections | – | – |
| Adductor (+/- psoas) muscle releases alone | – | – |
| Hip reconstructive surgery | – | – |
| Salvage hip surgery | – | – |
Who may qualify
- Ages
- 2 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
Time frame: The CPCHILD takes approximately 15 minutes to complete
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Unni G Narayanan principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Unni G Narayanan, MD (416-813-6432, unni.narayanan@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) (time frame: The CPCHILD takes approximately 15 minutes to complete). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.