Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-25 @ 7:22 PM
Study NCT ID:
NCT02242994
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2014-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akrieger@childrensnational.org', 'phone': '2024761284', 'title': 'Dr. Axel Krieger', 'organization': "Children's National"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.\n\nDynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.\n\nExperimental App: Participant receives experimental app to test speed and error rate of communication.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Speed of Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.\n\nDynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.\n\nExperimental App: Participant receives experimental app to test speed and error rate of communication.'}], 'classes': [{'title': 'Experimental App', 'categories': [{'measurements': [{'value': '8.13', 'spread': '12.61', 'groupId': 'OG000'}]}]}, {'title': 'Dynavox', 'categories': [{'measurements': [{'value': '2.96', 'spread': '4.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately', 'description': 'Measure time (in minutes) to type 3 pre-set sentences', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Error Rate of Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.\n\nDynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.\n\nExperimental App: Participant receives experimental app to test speed and error rate of communication.'}], 'classes': [{'title': 'Experimental App', 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.45', 'groupId': 'OG000'}]}]}, {'title': 'Dynavox', 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of experiment', 'description': 'Amount of typing errors per sentence', 'unitOfMeasure': 'errors', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.\n\nDynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.\n\nExperimental App: Participant receives experimental app to test speed and error rate of communication.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.\n\nDynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.\n\nExperimental App: Participant receives experimental app to test speed and error rate of communication.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '4.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Age 7-21'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2014-07-24', 'resultsFirstSubmitDate': '2016-10-24', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-24', 'studyFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed of Communication', 'timeFrame': 'Immediately', 'description': 'Measure time (in minutes) to type 3 pre-set sentences'}], 'secondaryOutcomes': [{'measure': 'Error Rate of Communication', 'timeFrame': 'At time of experiment', 'description': 'Amount of typing errors per sentence'}]}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between the ages of 7 years old - 21 years old\n* been diagnosed with spastic or dystonic diplegic or quadriplegic cerebral palsy.\n* are able to communicate through written words\n* are able to follow a 3- steps directions, and follow study directions and procedures.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02242994', 'briefTitle': 'Data Acquisition Study for a Communication Device for Pediatric Patients With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': "Children's National Research Institute"}, 'orgStudyIdInfo': {'id': 'Pro00003767'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynavox Maestro and Experimental App', 'description': 'Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.', 'interventionNames': ['Device: Dynavox Maestro', 'Device: Experimental App']}], 'interventions': [{'name': 'Dynavox Maestro', 'type': 'DEVICE', 'description': 'Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.', 'armGroupLabels': ['Dynavox Maestro and Experimental App']}, {'name': 'Experimental App', 'type': 'DEVICE', 'description': 'Participant receives experimental app to test speed and error rate of communication.', 'armGroupLabels': ['Dynavox Maestro and Experimental App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axel Krieger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Axel Krieger', 'investigatorAffiliation': "Children's National Research Institute"}}}}