Cerebral Palsy Hip Outcomes Project - International Multi-centre Study

Cerebral Palsy Clinical Trial

Official title:

Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-centre Prospective Comparative Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01987882
• Other study ID #: 313575
• Status: Recruiting
• Start date: June 2014
• Est. completion date: April 2022

Study information

• Verified date: February 2021
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: Dr. Unni Narayanan, MBBS, MSc, FRCSC
• Email: unni.narayanan[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary purpose of the project is to evaluate the effectiveness of different intervention strategies to prevent or relieve symptoms associated with hip instability in children with severe cerebral palsy, 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 for this population.

Description:

Background: Children with severe cerebral palsy (CP) are at high risk for dislocating their hips. These hips are associated with contractures and pain, which can interfere with care-giving, seating, positioning, mobility and quality of life. The primary purpose of this project (Aim 2) is to evaluate the effectiveness of different intervention strategies to prevent or relieve the symptoms associated with hip instability in children with severe non-ambulatory CP, 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. Secondarily, this project will also measure the impact of hip displacement on HRQL of these children. This project will be the first of its kind and this scale, which will systematically 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. The international network of investigators/sites and the infrastructure established for this project will facilitate the long term follow-up of the participants in this study, as well as the conduct of other multi-centre clinical trials and cohort studies to evaluate the effectiveness of current and future interventions aimed at improving the quality of life of children with severe disabilities.

Study Design & Participants: International multi-centre prospective longitudinal cohort study of children with severe (non-ambulant) cerebral palsy (GMFCS levels IV & V) from ages 3 to 18 who have radiographic evidence of hip displacement [Reimer's Migration Percentage (MP) ≥ 30%].

Measures: Detailed demographic information, and prognostic factors, including co-morbid conditions will be recorded at baseline, in addition to self-administered parental reports of HRQL as measured by the CPCHILD. Hip status will be classified using standardized radiographic measures of Reimer's MP and acetabular index (AI). The primary outcome measure CPCHILD, as well as the MP & AI will be measured at 6, 12 and 24 months following initial intervention.

Aim 1: Measure the impact of increasing hip displacement in children with severe (non-ambulant) CP on their HRQL as measured by the CPCHILD questionnaire.

Aim 2: (Primary Purpose): Measure the effectiveness of different strategies of interventions for hip displacement in children with severe (non-ambulant) CP in a prospective longitudinal comparative cohort study using the CPCHILD as the primary outcome measure of HRQL.

Aim 3: Compare the types and rates of adverse events and complications associated with each of the treatment cohorts.

Methods: Observational study of usual (site/surgeon specific) clinical practice. Investigators at each site will enroll eligible participants and assign each to one of the following 5 cohorts based on individual treating doctor's &/or parental preferences:

A. "Natural" history or watchful waiting (N=100)

B. Serial botulinum toxin injections +/- abduction bracing (N=100)

C. Adductor (+/- psoas) muscle releases alone (N=100)

D. Hip reconstructive surgery (N=100)

E. Salvage hip surgery (N=100)

The baseline MP and CPCHILD scores for all participants will be analyzed cross-sectionally to evaluate the correlation between hip displacement and the CPCHILD scores to serve Aim 1. For Aim 2, children undergoing interventions for hip instability (Groups B, C, D, & E) will be compared with each other as well as with their respective matched counterparts of untreated children (Group A), using repeated measures of analysis of covariance (ANOCOVA) to measure the mean change in scores from baseline at 6, 12 and 24 months after intervention.

Timelines: 500 participants will be recruited in 24 months, and followed for 24 months. The analysis, reporting of results, manuscript development and knowledge transfer will take 12 months. In total, the study will take 5 years to complete.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children with a working diagnosis of cerebral palsy or cerebral palsy-like condition

• Between 2 to 18 years of age

• Has a migration percentage = 30%

• Non-ambulatory; the primary mode of mobility is a wheelchair

• Parent/primary caregiver must understand one of the languages in which the CPCHILD has been translated, culturally adapted and validated.

Exclusion Criteria:

• History of prior hip surgery

• Received botulinum toxin injection within the previous 3 months. Recruitment will be delayed until at least 3 months after prior botulinum toxin injection.

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Australia	Royal Children's Hospital	Melbourne	Victoria
Canada	Shriners Hospital for Children - Canada	Montreal	Quebec
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	British Columbia
Denmark	Aarhus University Hospital	Aarhus
Israel	Safra Hospital for Children	Tel Hashomer	Ramat Gan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
New Zealand	Starship Children's Hospital of New Zealand	Auckland
Poland	K. Marcinkowski Medical University	Poznan
Sweden	Lund University Hospital	Lund
Sweden	Astrid Lindgren's Children's Hospital	Stockholm
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry	England
United Kingdom	Royal Hospital for Sick Children	Edinburgh	Scotland
United Kingdom	Alder Hey Children's NHS Foundation Trust	Liverpool	England
United Kingdom	Royal National Orthopaedic Hospital	London	England
United Kingdom	The Royal London and St. Bartholomew's Hospitals	London	England
United Kingdom	Nuffield Orthopaedic Centre NHS Trust	Oxford	England
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's of Mississippi	Jackson	Mississippi
United States	Hospital for Special Surgery	New York	New York
United States	New York-Presbyterian Morgan Stanley Children's Hospital	New York	New York
United States	Shriners Hospitals for Children - Northern California	Sacramento	California
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Alfred I. Dupont Institute	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital	The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Denmark,  Israel,  Korea, Republic of,  New Zealand,  Poland,  Sweden,  United Kingdom, 

References & Publications (1)

Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell K. Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD). Dev Med Child Neurol. 2006 Oct;48(10):804-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events and Complications		Adverse events will be recorded up to 24 months after treatment
Primary	CPCHILD questionnaire: Total Score (0-100)	The primary outcome measure will be based at the 12 month assessment. The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.	Change from baseline to 12 months after treatment
Secondary	CPCHILD Questionnaire: Total Score (0-100)	The CPCHILD questionnaire is a validated outcome measure of health-related quality of life specifically developed for children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) to evaluate the effectiveness of different treatment options.	Change from baseline to 24 months after treatment
Secondary	Reimer's Migration Percentage (MP)	The Reimer's Migration Percentage (MP) quantifies the magnitude of the displacement of the femoral head that is uncovered by the acetabulum.	Change from baseline to 24 months after treatment
Secondary	Acetabular Index (AI) in degrees	The Acetabular Index (AI) in degrees quantifies the magnitude of acetabular dysplasia.	Change from baseline to 24 months after treatment
Secondary	Morphological Hip Classification in Cerebral Palsy (MHC)	The Morphological Hip Classification in Cerebral Palsy (MHC) describes the sphericity of the femoral head.	Change from baseline to 24 months after treatment
Secondary	CPCHILD Questionnaire: Subscale Scores (0 - 100)	The Subscale scores of the CPCHILD© questionnaire represent the following domains: Activities of Daily Living/Personal Care (9 items); Positioning, Transferring & Mobility (8); Comfort & Emotions (9); Communication & Social Interaction (7); Health (3); Overall Quality of Life (1).; Standardized scores are generated on a scale of 0 (worst) to 100 (best) for each of the 6 domains.	Change from baseline to 24 months after treatment

External Links

•   Website of the CPCHILD© Project