- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773161
Cerebral Palsy Hip Health Related Quality of Life
January 8, 2018 updated by: Kishore Mulpuri, University of British Columbia
Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips
Children with cerebral palsy are at an increased risk of having their hips move partially or completely out of joint.
This can cause pain and restrict movement at the hip, making sitting in a wheelchair uncomfortable and make personal care difficult.
This condition may be treated with surgery.
Surgeons use x-rays taken before and after the surgery to determine whether or not the surgery has been successful.
However, it is also important to know whether the surgery has improved life from the child or the caregiver's point of view.
The investigators will also evaluate if waiting for surgery affects the child.
This information will be added to results from a physical exam and an evaluation of the child's x-rays for a more complete picture of how this surgery impacts the lives of our patients.
It is predicted that that the health-related quality of life of children with cerebral palsy will improve following surgery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
HRQoL will be measured using the Child Health Index of Life with Disabilities (CPCHILD).
Our specific hypothesis is that health related quality of life, as measured by the CPCHILD will change by at least a mean of 10 points from pre- to post-surgery.
Study Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
-
-
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
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital
Description
Inclusion Criteria:
- Ages 4-18
- Undergoing surgical treatment for hip subluxation or dislocation
- Diagnosis of cerebral palsy or similar condition causing motor impairment
- Consent to participate
Exclusion Criteria:
- Diagnosis of neuromuscular disorders other than cerebral palsy
- younger than 4, older than 18
- Reimer's migration percentage <40%
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cerebral palsy, post hip surgery
Children between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy.
|
All subjects will undergo surgical treatment for hip subluxation or dislocation.
HRQoL, radiographic, and clinical data will be measured at multiple time points.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life from pre-op to one year post-op
Time Frame: Baseline to 1 year post-op
|
Change in quality of life will be measured by the Caregiver Priorities and Child Health Index of Life with Disabilities questionnaires.
|
Baseline to 1 year post-op
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in variables obtained from physical and radiological examination
Time Frame: Baseline to 1 year post-op
|
A physical exam includes: child's range of motion at the hip, true hamstring length, tone, Gross Motor Function Classification System level, functional mobility, and pain. Radiological measures include: acetabular index, centre edge angle of Wiberg and shape of head, avascular necrosis of the femoral head, arthritis, pelvic obliquity, Cobb's angle for scoliosis. |
Baseline to 1 year post-op
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kishore Mulpuri, MBBS, MS, MHSc, University of British Columbia
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
February 1, 2011
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
January 11, 2013
First Submitted That Met QC Criteria
January 17, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Actual)
January 10, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-03210
- CW11-0006 (Other Identifier: Children's and Women's Health Centre of BC (incl. Sunny Hill))
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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