Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-20 @ 1:35 PM
Study NCT ID:
NCT02834195
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2016-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Types of Upper Limb and Hand in Patients With Cerebral Palsy
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': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in upper limb pattern classification of each examiner between day 1 and month 2', 'timeFrame': 'examiner classification at day 1 and at month 2.', 'description': 'Intra-rater reliability of a classification of upper limb pattern in patients with cerebral palsy.'}, {'measure': 'Change in hand pattern classification of each examiner between day 1 and month 2', 'timeFrame': 'examiner classification at day 1 and at month 2.', 'description': 'Intra-rater reliability of a classification of hand pattern in patients with cerebral palsy.'}, {'measure': 'Change between examiner classification and the expert examiner classification', 'timeFrame': 'Expert examiner classification (day 1) and examiner classification (week 4)', 'description': "Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval Inter-rater reliability of a classification of upper limb pattern in patients with cerebral palsy."}, {'measure': 'Change between examiner classification and the expert examiner classification', 'timeFrame': 'Expert examiner classification (day 1) and examiner classification (week 4)', 'description': "Level of agreement will be determined with Fleiss's kappa (k) and its 95% confidence interval.\n\nInter-rater reliability of a classification of hand pattern in patients with cerebral palsy."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'reliability', 'upper limb and hand patterns', 'classification'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Cerebral palsy (CP) has been defined as "a group of permanent disorders of the development of movement and posture causing activity limitation(s) that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain".\n\nInvestigators previously developed two classification systems, one for the upper limb and one for the hand, based on 100 films of patients with cerebral palsy. Separate classifications were developed following an initial study in which investigators found no correlations between upper limb and hand patterns, meaning that specific upper limb patterns are not always associated with specific hand patterns. Thumb patterns were not included in these classifications since robust classifications already exist, moreover thumb patterns are independent from hand patterns.\n\nThe aim is to evaluate the inter- and intra-rater reliability of two previously developed classifications of upper limb and hand patterns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cerebral palsy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cerebral palsy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02834195', 'acronym': 'CLASS-MS', 'briefTitle': 'Types of Upper Limb and Hand in Patients With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Validation of a Classification of Types of Upper Limb and Hand in Patients With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'D21882'}}, 'contactsLocationsModule': {'locations': [{'zip': '69424', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche - 162 avenue Lacassagne - Bâtiment A', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Sandrine TOUZET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon, Pôle Information Médicale, Evaluation, Recherche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}