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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01987882
Registration number
NCT01987882
Ethics application status
Date submitted
13/11/2013
Date registered
19/11/2013
Date last updated
11/02/2021
Titles & IDs
Public title
Cerebral Palsy Hip Outcomes Project - International Multi-centre Study
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Scientific title
Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-centre Prospective Comparative Cohort Study
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Secondary ID [1]
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313575
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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 -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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CPCHILD questionnaire: Total Score (0-100)
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Assessment method [1]
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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.
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Timepoint [1]
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Change from baseline to 12 months after treatment
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Secondary outcome [1]
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CPCHILD Questionnaire: Total Score (0-100)
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Assessment method [1]
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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.
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Timepoint [1]
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Change from baseline to 24 months after treatment
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Secondary outcome [2]
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Reimer's Migration Percentage (MP)
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Assessment method [2]
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The Reimer's Migration Percentage (MP) quantifies the magnitude of the displacement of the femoral head that is uncovered by the acetabulum.
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Timepoint [2]
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Change from baseline to 24 months after treatment
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Secondary outcome [3]
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Acetabular Index (AI) in degrees
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Assessment method [3]
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The Acetabular Index (AI) in degrees quantifies the magnitude of acetabular dysplasia.
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Timepoint [3]
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Change from baseline to 24 months after treatment
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Secondary outcome [4]
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Morphological Hip Classification in Cerebral Palsy (MHC)
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Assessment method [4]
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The Morphological Hip Classification in Cerebral Palsy (MHC) describes the sphericity of the femoral head.
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Timepoint [4]
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Change from baseline to 24 months after treatment
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Secondary outcome [5]
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CPCHILD Questionnaire: Subscale Scores (0 - 100)
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Assessment method [5]
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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.
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Timepoint [5]
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Change from baseline to 24 months after treatment
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Eligibility
Key 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.
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Minimum age
2
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2022
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Delaware
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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New York
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United States of America
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Ohio
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus
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Israel
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Ramat Gan
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Korea, Republic of
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Gyeonggi-do
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New Zealand
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Auckland
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Poland
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Poznan
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Sweden
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Lund
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Sweden
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Stockholm
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United Kingdom
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England
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United Kingdom
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Scotland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Holland Bloorview Kids Rehabilitation Hospital
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Address
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Other collaborator category [1]
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Other
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Name [1]
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The Hospital for Sick Children
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01987882
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Trial related presentations / publications
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. doi: 10.1017/S0012162206001745.
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Public notes
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Contacts
Principal investigator
Name
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Dr. Unni Narayanan, MBBS, MSc, FRCSC
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Address
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Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada
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Fax
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Email
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Contact person for public queries
Name
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Dr. Unni Narayanan, MBBS, MSc, FRCSC
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01987882
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