Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-30 @ 10:12 AM
Study NCT ID:
NCT01657994
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2012-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Functional Electrical Stimulation & Robotic Gait Training for Children 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2012-05-17', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Gross Motor Function Measure-66 using multiple baseline assessments', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}], 'secondaryOutcomes': [{'measure': 'Change in strength via myometry', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in Observational Gait Scale', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in Modified Ashworth Scale', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in Goniometry at the knee', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in 6 minute walk', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in 10 meter walk', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': "Change in Children's Assessment of Participation and Enjoyment", 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in Cerebral Palsy Quality of Life Questionnaire', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}, {'measure': 'Change in Canadian Occupational Performance Measure', 'timeFrame': '4 times (9-0 weeks) before treatment, 3 times (6-12 weeks) after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'gait training', 'robotic', 'functional electrical stimulation'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn more about the usefulness of a physical therapy treatment that combines robot-assisted walking with electrical impulses that help to make muscles contract. This treatment is intended for children with cerebral palsy. Up to eleven children with cerebral palsy will receive up to 18 treatments and will have several evaluations before and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GMFCS II, III, or IV cerebral palsy\n* 5-12 years of age\n* meet safety criteria for robotic gait training (\\<300 lbs, intact skin, femoral length 21-47 cm, ability to follow simple instructions)\n* meet safety criteria for functional electrical stimulation (voluntary hip and knee muscle contraction, intact skin)\n\nExclusion Criteria:\n\n* planned major intervention during study period\n* contractures that interfere with upright stance\n* history of non-traumatic long bone fracture or clinically significant osteoporosis\n* significant concurrent illness\n* significant condition not typically associated with cerebral palsy'}, 'identificationModule': {'nctId': 'NCT01657994', 'briefTitle': 'Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'R-796-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'therapy plus fes', 'description': 'robotic gait training plus functional electrical stimulation', 'interventionNames': ['Other: Combined functional electrical stimulation and robotic gait training']}], 'interventions': [{'name': 'Combined functional electrical stimulation and robotic gait training', 'type': 'OTHER', 'otherNames': ['Lokomat', 'RT-50'], 'description': 'up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks', 'armGroupLabels': ['therapy plus fes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Jilda Vargus-Adams, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Cerebral Palsy International Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}