Cerebral Palsy Hip Health Related Quality of Life

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01773161
• Other study ID #: H10-03210
• Secondary ID: CW11-0006
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: January 8, 2018
• Start date: February 2011
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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%

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Patient Undergoing Hip Surgery
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life from pre-op to one 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	Changes in variables obtained from physical and radiological examination	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