Cerebral Palsy Hip Outcomes Project - International Multi-centre Study



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:2 - 18
Updated:12/8/2018
Start Date:June 2014
End Date:April 2020
Contact:Dr. Unni Narayanan, MBBS, MSc, FRCSC
Email:unni.narayanan@sickkids.ca

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
10
sites
535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
?
mi
from
New York, NY
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Jackson, Mississippi 39564
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Melbourne, Victoria 3051
?
mi
from
Melbourne,
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saint Paul, Minnesota 55101
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Wilmington, Delaware
?
mi
from
Wilmington, DE
Click here to add this to my saved trials