Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT01773161
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2013-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Palsy Hip Health Related Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2013-01-11', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life from pre-op to one year post-op', 'timeFrame': 'Baseline to 1 year post-op', 'description': 'Change in quality of life will be measured by the Caregiver Priorities and Child Health Index of Life with Disabilities questionnaires.'}], 'secondaryOutcomes': [{'measure': 'Changes in variables obtained from physical and radiological examination', 'timeFrame': 'Baseline to 1 year post-op', 'description': "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.\n\nRadiological 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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Hip surgery', 'Quality of Life'], 'conditions': ['Cerebral Palsy', 'Patient Undergoing Hip Surgery', 'Quality of Life']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Children with cerebral palsy who are undergoing surgery for hip subluxation/dislocation at BC Children's Hospital", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 4-18\n* Undergoing surgical treatment for hip subluxation or dislocation\n* Diagnosis of cerebral palsy or similar condition causing motor impairment\n* Consent to participate\n\nExclusion Criteria:\n\n* Diagnosis of neuromuscular disorders other than cerebral palsy\n* younger than 4, older than 18\n* Reimer's migration percentage \\<40%"}, 'identificationModule': {'nctId': 'NCT01773161', 'briefTitle': 'Cerebral Palsy Hip Health Related Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Health Related Quality of Life in Patients With Cerebral Palsy Undergoing Surgery for Dislocating Hips', 'orgStudyIdInfo': {'id': 'H10-03210'}, 'secondaryIdInfos': [{'id': 'CW11-0006', 'type': 'OTHER', 'domain': "Children's and Women's Health Centre of BC (incl. Sunny Hill)"}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cerebral palsy, post hip surgery', 'description': 'Children between the ages of 4-18 undergoing surgical treatment for hip subluxation or dislocation secondary to cerebral palsy.', 'interventionNames': ['Procedure: Cerebral palsy, post hip surgery']}], 'interventions': [{'name': 'Cerebral palsy, post hip surgery', 'type': 'PROCEDURE', 'description': 'All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.', 'armGroupLabels': ['Cerebral palsy, post hip surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Kishore Mulpuri, MBBS, MS, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Kishore Mulpuri', 'investigatorAffiliation': 'University of British Columbia'}}}}