Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00175669
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The primary outcome will be based on gait analysis data - specifically whether post injection gait analyses show a reduction in the features that were used to determine the severity of the subjects' toe walking problem.", 'timeFrame': 'Data not known'}], 'secondaryOutcomes': [{'measure': 'Ankle range of motion (dorsiflexion and plantarflexion)', 'timeFrame': 'collected at every visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized control trial; placebo-control study'], 'conditions': ['Idiopathic Toe Walking']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of Botox and casting to placebo and casting for reducing toe walking problems in children who are idiopathic toe walkers.', 'detailedDescription': "Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking will be eligible for the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British Columbia's Children's Hospital and have been referred to the Shriner's gait lab for assessment of idiopathic toe walking\n* Clinical toe walkers - toe walkers as per gait lab's definition (loss of 1st ankle rocker, early heel rise \\[prior to 30% of the cycle\\] and A1 kinematic data)\n* Aged 5 - 15 years old\n* Parents and patients educated about protocol and willing to partake\n* Cooperative patient with gait analysis and injection"}, 'identificationModule': {'nctId': 'NCT00175669', 'briefTitle': 'Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Randomized Controlled Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking', 'orgStudyIdInfo': {'id': 'C00-0160'}, 'secondaryIdInfos': [{'id': 'CW: 00-0500'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Botox injections', 'type': 'DRUG', 'description': 'Data not known.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital, Department of Orthopaedics", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Christine Alvarez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Christine Alvarez', 'oldOrganization': 'University of British Columbia'}}}}