Cerebral Palsy Hip Outcomes Project - International Multi-centre Study

February 9, 2021 updated by: Holland Bloorview Kids Rehabilitation Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • Royal Children's Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • BC Children's Hospital
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada
        • Recruiting
        • Holland Bloorview Kids Rehabilitation Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Shriners Hospital for Children - Canada
  • Denmark
      • Aarhus, Denmark
        • Recruiting
        • Aarhus University Hospital
  • Israel
    • Ramat Gan
      • Tel Hashomer, Ramat Gan, Israel
        • Recruiting
        • Safra Hospital for Children
  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Starship Children's Hospital of New Zealand
  • Poland
      • Poznan, Poland
        • Recruiting
        • K. Marcinkowski Medical University
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Lund University Hospital
      • Stockholm, Sweden
        • Not yet recruiting
        • Astrid Lindgren's Children's Hospital
  • United Kingdom
    • England
      • Coventry, England, United Kingdom
        • Recruiting
        • University Hospitals Coventry & Warwickshire NHS Trust
      • Liverpool, England, United Kingdom
        • Recruiting
        • Alder Hey Children's NHS Foundation Trust
      • London, England, United Kingdom
        • Recruiting
        • Royal National Orthopaedic Hospital
      • London, England, United Kingdom
        • Recruiting
        • The Royal London and St. Bartholomew's Hospitals
      • Oxford, England, United Kingdom
        • Recruiting
        • Nuffield Orthopaedic Centre NHS Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom
        • Recruiting
        • Royal Hospital for Sick Children
  • United States
    • California
      • Sacramento, California, United States
        • Recruiting
        • Shriners Hospitals for Children - Northern California
    • Colorado
      • Aurora, Colorado, United States
        • Recruiting
        • Children's Hospital Colorado
    • Delaware
      • Wilmington, Delaware, United States
        • Recruiting
        • Alfred I. Dupont Institute
    • Massachusetts
      • Boston, Massachusetts, United States
        • Recruiting
        • Children's Hospital Boston
    • Minnesota
      • Saint Paul, Minnesota, United States
        • Recruiting
        • Gillette Children's Specialty Healthcare
    • Mississippi
      • Jackson, Mississippi, United States
        • Recruiting
        • Children's of Mississippi
    • New York
      • New York, New York, United States
        • Recruiting
        • Hospital For Special Surgery
      • New York, New York, United States
        • Recruiting
        • New York-Presbyterian Morgan Stanley Children's Hospital
    • Ohio
      • Cincinnati, Ohio, United States
        • Recruiting
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with severe, non-ambulant cerebral palsy (GMFCS level IV and V) and their parent / primary caregiver will be enrolled in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
A. "Natural" History or Watchful Waiting
B. Serial Botulinum Toxin Injections +/- Abduction Bracing
C. Adductor (+/- psoas) Muscle Releases Alone
D. Hip Reconstructive Surgery
E. Salvage Hip Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPCHILD questionnaire: Total Score (0-100)
Time Frame: Change from baseline to 12 months after treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPCHILD Questionnaire: Total Score (0-100)
Time Frame: Change from baseline to 24 months after treatment
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
Reimer's Migration Percentage (MP)
Time Frame: Change from baseline to 24 months after treatment
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
Acetabular Index (AI) in degrees
Time Frame: Change from baseline to 24 months after treatment
The Acetabular Index (AI) in degrees quantifies the magnitude of acetabular dysplasia.
Change from baseline to 24 months after treatment
Morphological Hip Classification in Cerebral Palsy (MHC)
Time Frame: Change from baseline to 24 months after treatment
The Morphological Hip Classification in Cerebral Palsy (MHC) describes the sphericity of the femoral head.
Change from baseline to 24 months after treatment
CPCHILD Questionnaire: Subscale Scores (0 - 100)
Time Frame: Change from baseline to 24 months after treatment

The Subscale scores of the CPCHILD© questionnaire represent the following domains:

  1. Activities of Daily Living/Personal Care (9 items);
  2. Positioning, Transferring & Mobility (8);
  3. Comfort & Emotions (9);
  4. Communication & Social Interaction (7);
  5. Health (3);
  6. 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

Other Outcome Measures

Outcome Measure
Time Frame
Adverse Events and Complications
Time Frame: Adverse events will be recorded up to 24 months after treatment
Adverse events will be recorded up to 24 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holland Bloorview Kids Rehabilitation Hospital

Collaborators

The Hospital for Sick Children

Investigators

  • Principal Investigator: Dr. Unni Narayanan, MBBS, MSc, FRCSC, Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

November 13, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 19, 2013

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 313575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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