Cerebral PalsyNCT01773161
Cerebral Palsy Hip Health Related Quality of Life
An observational study of Cerebral Palsy and Patient Undergoing Hip Surgery, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Patient Undergoing Hip Surgery, Quality of Life
- What is being tested?
- Cerebral palsy, post hip surgery
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital
Who may be able to join
- Ages 4-18
- Undergoing surgical treatment for hip subluxation or dislocation
- Diagnosis of cerebral palsy or similar condition causing motor impairment
- Consent to participate
Who cannot join
- Diagnosis of neuromuscular disorders other than cerebral palsy
- younger than 4, older than 18
- Reimer's migration percentage <40%
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: 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.
Read the 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.
- Being tested
- Cerebral palsy, post hip surgery
- Keywords
- Cerebral Palsy, Hip surgery, Quality of Life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral palsy, post hip surgeryProcedure or surgery
All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral palsy, post hip surgery | Children between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy. Receives: Procedure: Cerebral palsy, post hip surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 year post-op
Secondary outcomes (1)
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.
Measured: Baseline to 1 year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startFeb 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, MBBS, MS, MHSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773161
- Sponsor's protocol ID
- H10-03210
- Other IDs
- CW11-0006
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2013
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips
- ClinicalTrials.gov ID
- NCT01773161
- Acronym / sponsor ID
- H10-03210
- Keywords
- Cerebral Palsy, Hip surgery, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral palsy, post hip surgery | – | Procedure: Cerebral palsy, post hip surgeryChildren between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital
Key inclusion criteria (4 listed)
- Ages 4-18
- Undergoing surgical treatment for hip subluxation or dislocation
- Diagnosis of cerebral palsy or similar condition causing motor impairment
- Consent to participate
Key exclusion criteria (3 listed)
- Diagnosis of neuromuscular disorders other than cerebral palsy
- younger than 4, older than 18
- Reimer's migration percentage <40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral palsy, post hip surgeryAll subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points. | Procedure or surgery | Cerebral palsy, post hip surgery |
Primary outcome
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.
1 secondary outcome
Changes in variables obtained from physical and radiological examination
Time frame: Baseline to 1 year post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishore Mulpuri, MBBS, MS, MHSc principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Patient Undergoing Hip Surgery, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life from pre-op to one year post-op (time frame: Baseline to 1 year post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.