Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-03-30 @ 11:55 PM
Study NCT ID:
NCT00473161
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2007-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001247', 'term': 'Asthenia'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D009069', 'term': 'Movement Disorders'}], '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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2007-05-11', 'studyFirstSubmitQcDate': '2007-05-11', 'lastUpdatePostDateStruct': {'date': '2014-05-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['movement disorders', 'childhood'], 'conditions': ['Cerebral Palsy', 'Weakness', 'Hypertonia']}, 'descriptionModule': {'briefSummary': 'A newly-developed device for biofeedback of surface EMG will be used to either increase or decrease activity in the muscles of children with poor reaching due to cerebral palsy.', 'detailedDescription': 'Children ages newborn to 21 with a diagnosis of arm weakness, hypertonia, or hyperkinesia due to cerebral palsy will be recruited. A muscle that is either over-active or under-active will be selected for each child. The child will be provided with the device to wear for 1 month in order to call attention to the identified muscle. At the beginning and end of the month, reaching will be assessed using three-dimensional kinematic motion capture. The outcome measure will be the speed and curvature of reaching to a target in front of the child.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with movement disorders, cerebral palsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* weakness, hypertonia, or hyperkinetic disorder affecting one or both arms\n* reduced speed or quality of reaching\n\nExclusion Criteria:\n\n* any condition that would increase the risk of participation'}, 'identificationModule': {'nctId': 'NCT00473161', 'briefTitle': 'Use of Surface Electromyography Biofeedback to Improve Reaching in Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'orgStudyIdInfo': {'id': 'EMG biofeedback'}}, 'armsInterventionsModule': {'interventions': [{'name': 'surface EMG biofeedback', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Terence D Sanger, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Terence Sanger', 'investigatorAffiliation': 'University of Southern California'}}}}