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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
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
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
Trial website
Trial related presentations / publications
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

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