Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01028833
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2009-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Power Mobility on Young Children With Severe Motor Impairments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D001176', 'term': 'Arthrogryposis'}, {'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], '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': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Merrill-Palmer-Revised', 'timeFrame': 'Entry, 6-months, and 12-months'}, {'measure': 'Pediatric Evaluation of Disability Inventory', 'timeFrame': 'Entry, 6-months, 12-months'}], 'secondaryOutcomes': [{'measure': 'Child Health Status', 'timeFrame': 'Entry'}, {'measure': 'Two-position object permanence test', 'timeFrame': 'Entry, 6 months, 12 months'}, {'measure': 'Nonspeech Test', 'timeFrame': 'Entry, 6 month, 12 months'}, {'measure': 'Home Observation Measure of the Environment', 'timeFrame': 'Entry, 6 months, 12 months'}, {'measure': 'Parenting Stress Inventory', 'timeFrame': 'Entry, 6 months, 12 months'}, {'measure': 'Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': 'Entry, 6 months, 12 months'}, {'measure': 'Hollingshead Scale', 'timeFrame': 'Entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['power wheelchairs', 'power mobility', 'young children'], 'conditions': ['Cerebral Palsy', 'Arthrogryposis', 'Spinal Muscular Atrophy', 'Other Central Nervous System or Musculoskeletal Disorders']}, 'referencesModule': {'references': [{'pmid': '28688787', 'type': 'DERIVED', 'citation': 'Mockler SR, McEwen IR, Jones MA. Retrospective Analysis of Predictors of Proficient Power Mobility in Young Children With Severe Motor Impairments. Arch Phys Med Rehabil. 2017 Oct;98(10):2034-2041. doi: 10.1016/j.apmr.2017.05.028. Epub 2017 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily restrict their cognitive, communication, and social-emotional development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Months', 'minimumAge': '14 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between 14- and 30-months of age\n* Must have clinical diagnosis of a motor impairment that prevents functional independent mobility\n* Must have adequate vision and hearing to use power mobility device safely\n* Must have cognitive abilities equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted'}, 'identificationModule': {'nctId': 'NCT01028833', 'briefTitle': 'Effects of Power Mobility on Young Children With Severe Motor Impairments', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Effects of Power Mobility on the Development and Function of Young Children With Severe Motor Impairments', 'orgStudyIdInfo': {'id': '2480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Power mobility', 'description': 'Intervention included provision of power wheelchair and power mobility training program. Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.', 'interventionNames': ['Other: Power mobility']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Children in the control group will not receive any additional intervention, but will continue to receive the early intervention or other services they were receiving prior to enrollment in this study.'}], 'interventions': [{'name': 'Power mobility', 'type': 'OTHER', 'description': 'Project staff will use structured power mobility training program to teach the children to use the power mobility devices. Project staff will schedule 1-hour sessions with each family 3 times per week for the first month of the project and will decrease in the following manner as the child becomes proficient and develops basic wheelchair maneuvering skills: two one-hour session per week for 4 weeks; one one-hour session per week for 4 weeks; two one-hour sessions per month for 4 weeks; one one-hour session per month for the remainder of the study.', 'armGroupLabels': ['Power mobility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73117', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Department of Rehabilitation Sciences, Lee Mitchener Tolbert Center for Develompental Disabilities', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Maria A. Jones, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}