Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-18 @ 4:24 PM
Study NCT ID:
NCT00879450
Status:
TERMINATED
Last Update Posted:
2019-04-04
First Post:
2009-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}, {'id': 'C535425', 'term': 'Congenital torticollis'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'whyStopped': 'Clinical department where study was held was unable to continue collaboration', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2009-04-07', 'studyFirstSubmitQcDate': '2009-04-09', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck range of motion measurements', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Congenital muscular torticollis'], 'conditions': ['Torticollis']}, 'descriptionModule': {'briefSummary': 'Children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. This study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.', 'detailedDescription': '160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. Children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged newborn to 6 months at initial visit in physiotherapy,\n* A diagnosis of PT made by a physician,\n* At least 37 weeks of gestational age at delivery\n\nExclusion Criteria:\n\n* Congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery,\n* Presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon),\n* APGAR score of less than 7 at 5 minutes,\n* Prescription of a Tubular Orthosis for Torticollis (TOT) collar or Botox intervention for the torticollis,\n* Confirmed diagnosis of syndrome or neurological condition.'}, 'identificationModule': {'nctId': 'NCT00879450', 'briefTitle': 'Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants', 'orgStudyIdInfo': {'id': 'PED-08-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 Booklet', 'interventionNames': ['Other: Booklet']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 standard', 'interventionNames': ['Other: Booklet']}], 'interventions': [{'name': 'Booklet', 'type': 'OTHER', 'description': 'booklet given to parents for home exercises', 'armGroupLabels': ['1 Booklet', '2 standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3H 1P3', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Montreal Children's Hospital, MUHC", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Isabelle Gagnon', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}