Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT03714256
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2018-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Human Factor Validation of Pediatric Mobility Device
Sponsor:
Organization:
Raw JSON
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The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome', 'unitOfMeasure': 'Errors', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children 6-17 Months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.\n\nDevice, patient mobility, powered: Pediatric mobility device'}, {'id': 'FG001', 'title': 'Children 18 - 36 Months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.\n\nDevice, patient mobility, powered: Pediatric mobility device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Children 6-17 Months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.\n\nDevice, patient mobility, powered: Pediatric mobility device'}, {'id': 'BG001', 'title': 'Children 18 - 36 Months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.\n\nDevice, patient mobility, powered: Pediatric mobility device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-08-06', 'size': 295429, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-22T08:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-08', 'studyFirstSubmitDate': '2018-10-11', 'resultsFirstSubmitDate': '2020-10-22', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-08', 'studyFirstPostDateStruct': {'date': '2018-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Number of Use Errors Associated With the Usage of the Device According to Labelling', 'timeFrame': 'One day', 'description': 'The tasks in this Human factors validation test, that will be performed by the users are: charge battery and disconnect it, adjust seat and table height, adjust the speed, place the child in device, adjust cushion and other support. The summary of identified errors, captured through observation and interview, will be counted and define the primary outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pediatric'], 'conditions': ['Disability Physical']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users.', 'detailedDescription': 'The purpose of this study is to validate the user interface of a pediatric power mobility device by establishing that the product is safe and effective use for the intended users. The human factors validation study will be conducted in children with mobility impairments as categorised by Hays (1987) in the age range of 6 months to 36 months under realistic use conditions.The study is an open label, un-blinded, non-randomized study which consists of one visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary users:\n\n* Informed consent signed by parents or guardian\n* Aged 6-36 months\n* Unable to mobilize independently for exploratory play and peer interaction, as categorized by Hays (1987)\n* Adequate trunk and head control to remain upright in the device, including regain head control\n* Adequate hand/ arm (distal) control to reach for objects in front of them\n\nSecondary users:\n\n* Signed informed consent\n* Physiotherapist/Occupational Therapist or parent/guardian of the child included in the test\n\nExclusion Criteria:\n\n* Primary users:\n\n * Weight \\>16 kg/35 Ibs\n * Length \\>100 cm/39 In\n * Children that lack head control in such a severe manner that they cannot regain control if it is lost\n * Children who do not show awareness of or respond to toys, objects, sounds and/or people in their environment\n * Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test.\n\nSecondary users:\n\n* Hearing/vision loss or limited cognitive skills impacting the ability to take instructions and perform the tasks of the test\n* Ability to understand oral and written English as product labelling will in this Human Factor validation test only be available in English\n* Any other reason, if in the opinion of the investigator, the individual user is not appropriate, or suitable for participation in the test'}, 'identificationModule': {'nctId': 'NCT03714256', 'briefTitle': 'Human Factor Validation of Pediatric Mobility Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Permobil, Inc.'}, 'officialTitle': 'Human Factor Validation of Pediatric Mobility Device', 'orgStudyIdInfo': {'id': 'Per2018P04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children 6-17 months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.', 'interventionNames': ['Device: Device, patient mobility, powered']}, {'type': 'EXPERIMENTAL', 'label': 'Children 18 - 36 months', 'description': 'Device, patient mobility, powered:\n\nUsability of the pediatric mobility device by both parent/guardian and occupational/physiological therapist, performed according to instructions for use at a one time occasion.', 'interventionNames': ['Device: Device, patient mobility, powered']}], 'interventions': [{'name': 'Device, patient mobility, powered', 'type': 'DEVICE', 'description': 'Pediatric mobility device', 'armGroupLabels': ['Children 18 - 36 months', 'Children 6-17 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97331', 'city': 'Corvallis', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon State University', 'geoPoint': {'lat': 44.56457, 'lon': -123.26204}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Belmont University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Karin Leire', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Permobil Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Permobil, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}