Skip to main content
OpenTrials
Completed

NCT Number: NCT01773161

Cerebral Palsy Hip Health Related Quality of Life

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Patient Undergoing Hip Surgery Quality of Life

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Cerebral palsy, post hip surgery

Procedure

All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2013
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.