Cerebral Palsy Hip Health Related Quality of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01773161
First received: January 11, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cerebral Palsy
Patient Undergoing Hip Surgery
Quality of Life
Procedure: Cerebral palsy, post hip surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in quality of life from pre-op to one year post-op [ Time Frame: Baseline to 1 year post-op ] [ Designated as safety issue: No ]
    Change in quality of life will be measured by the Caregiver Priorities and Child Health Index of Life with Disabilities questionnaires.


Secondary Outcome Measures:
  • Changes in variables obtained from physical and radiological examination [ Time Frame: Baseline to 1 year post-op ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 24
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cerebral palsy, post hip surgery
Children between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy.
Procedure: Cerebral palsy, post hip surgery
All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital

Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773161

Contacts
Contact: Janice Andrade 604-875-2359 janice.andrade@cw.bc.ca

Locations
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Sub-Investigator: Stacey Miller, BSc(PT)         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kishore Mulpuri, MBBS, MS, MHSc University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01773161     History of Changes
Other Study ID Numbers: H10-03210, CW11-0006
Study First Received: January 11, 2013
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Cerebral Palsy
Hip surgery
Quality of Life

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014