Overview

This trial is active, not recruiting.

Conditions cerebral palsy, patient undergoing hip surgery, quality of life
Treatment cerebral palsy, post hip surgery
Sponsor University of British Columbia
Start date February 2011
End date December 2016
Trial size 24 participants
Trial identifier NCT01773161, CW11-0006, H10-03210

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Children between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy.
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.

Primary Outcomes

Measure
Change in quality of life from pre-op to one year post-op
time frame: Baseline to 1 year post-op

Secondary Outcomes

Measure
Changes in variables obtained from physical and radiological examination
time frame: Baseline to 1 year post-op

Eligibility Criteria

Male or female participants from 4 years up to 18 years old.

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%

Additional Information

Official title Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips
Principal investigator Kishore Mulpuri, MBBS, MS, MHSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.