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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Outcomes of Hip Interventions for Children With Cerebral Palsy - An International Multi-centre Prospective Comparative Cohort Study
Secondary ID [1] 0 0
313575
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
CPCHILD questionnaire: Total Score (0-100)
Timepoint [1] 0 0
Change from baseline to 12 months after treatment
Secondary outcome [1] 0 0
CPCHILD Questionnaire: Total Score (0-100)
Timepoint [1] 0 0
Change from baseline to 24 months after treatment
Secondary outcome [2] 0 0
Reimer's Migration Percentage (MP)
Timepoint [2] 0 0
Change from baseline to 24 months after treatment
Secondary outcome [3] 0 0
Acetabular Index (AI) in degrees
Timepoint [3] 0 0
Change from baseline to 24 months after treatment
Secondary outcome [4] 0 0
Morphological Hip Classification in Cerebral Palsy (MHC)
Timepoint [4] 0 0
Change from baseline to 24 months after treatment
Secondary outcome [5] 0 0
CPCHILD Questionnaire: Subscale Scores (0 - 100)
Timepoint [5] 0 0
Change from baseline to 24 months after treatment

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.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus
Country [13] 0 0
Israel
State/province [13] 0 0
Ramat Gan
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi-do
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Poland
State/province [16] 0 0
Poznan
Country [17] 0 0
Sweden
State/province [17] 0 0
Lund
Country [18] 0 0
Sweden
State/province [18] 0 0
Stockholm
Country [19] 0 0
United Kingdom
State/province [19] 0 0
England
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Other
Name
Holland Bloorview Kids Rehabilitation Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Hospital for Sick Children
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01987882
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Unni Narayanan, MBBS, MSc, FRCSC
Address 0 0
Holland Bloorview Kids Rehab and The Hospital for Sick Children, Toronto, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Unni Narayanan, MBBS, MSc, FRCSC
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01987882