Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 12:35 PM
Study NCT ID:
NCT06533293
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Neck Control in Children With Cerebral Palsy Using Robotics
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', 'maskingDescription': 'This is an exploratory study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2024-06-08', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seated Postural and Reaching Control (SP&R-co)', 'timeFrame': 'Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.', 'description': 'Measurement of head-trunk and reaching control of children and young adults with CP while sitting static, active, proactive, and reactive postural dimensions while providing support at different regions of the torso.'}], 'secondaryOutcomes': [{'measure': 'Gross Motor Functional Measure-items set (GMFM-IS)', 'timeFrame': 'Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.', 'description': 'This is an abbreviated version of the original GMFM-66 to measure the gross motor status of the children with CP across 5 dimensions: A) lying and rolling, B) Sitting, C) Crawling and Kneeling, D) Standing and E) Walking, Running and Jumping.'}, {'measure': 'Canadian Occupational Performance Outcome (COPM)', 'timeFrame': 'Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.', 'description': 'Measurement of perceived parent- and child-based goals and preferences that are specific to motor impediments that restrict participation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Motor training, Robotics'], 'conditions': ['Cerebral Palsy', 'Neck Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://scholar.google.com/citations?view_op=view_citation&hl=en&user=zavGyr4AAAAJ&cstart=20&pagesize=80&sortby=pubdate&citation_for_view=zavGyr4AAAAJ:j7XjBeKFbTsC', 'label': 'Amyotrophic lateral sclerosis patients regain head-neck control using a powered neck exoskeleton'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children.\n\nAim 1 is a cross-sectional study. In this single-session, kinematic and muscle activity data will be collected during the postural static, active-proactive, and reactive postural head tasks. Gross Motor Functional Classification System (GMFCS) levels will also be collected to categorize the sample into subgroups.\n\nAim 2 is a prospective cohort quasi-experimental study. The data will be collected at baseline, across 12 intervention sessions, 1 week post-intervention, and 3 months follow-up.\n\nFunctional assessments will be used to compare across the pre, mid, and post training. Participants will be assessed in Gross Motor Functional Measures (GMFM), Seated Posture and Reaching Control (SP\\&R-co), and Canadian Occupational and Performance Measure (COPM). The primary outcomes will be SP\\&R-co test and COPM pre- and post-intervention.', 'detailedDescription': 'The study investigators plan to recruit a sample of 30 children and adults (10 able-bodied children/young adults for the characterization phase and 20 children/young adults with bilateral cerebral palsy: 10 classified as GMFCS IV and 10 classified as GMFCS V). These participants will be aged 11-21 years.\n\nA motion capture/body mounted sensors and Electromyography (EMG) system will be used for measurement. This study will utilize specialized robotics that can apply gentle forces on the head-neck during movement training using the principles of motor learning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CP, as medical diagnosis\n* GMFCS IV-V classification\n\nExclusion Criteria:\n\n* severe cognitive deficits\n* uncontrolled epilepsy\n* severe dyskinesia\n* spinal cord malformations\n* severe vertebral column deformities (scoliosis \\>40° and/or kyphosis \\>45º)\n* blindness\n* chemo-denervation 3 months before study'}, 'identificationModule': {'nctId': 'NCT06533293', 'briefTitle': 'Improving Neck Control in Children With Cerebral Palsy Using Robotics', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace', 'orgStudyIdInfo': {'id': 'AAAV1209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device', 'description': 'Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.', 'interventionNames': ['Device: Neck Brace Device']}], 'interventions': [{'name': 'Neck Brace Device', 'type': 'DEVICE', 'description': 'The neck brace device will be manufactured in the Mechanical Department at Columbia University. The device measures head motion and EMG by electronic sensors, passively supports the head in certain configurations by springs, and actively assists head movement by motors.\n\nMotor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.', 'armGroupLabels': ['Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sunil Agrawal, PhD', 'role': 'CONTACT', 'email': 'sunil.agrawal@columbia.edu', 'phone': '212-854-2841'}], 'facility': 'ROAR Lab, Mudd Hall', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sunil Agrawal', 'role': 'CONTACT', 'email': 'sunil.agrawal@columbia.edu', 'phone': '212-854-2841'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Sunil K Agrawal, PhD', 'role': 'CONTACT', 'email': 'sunil.agrawal@columbia.edu', 'phone': '2128542841'}, {'name': 'Victor Santamaria', 'role': 'CONTACT', 'email': 'vsantama@nymc.edu'}], 'overallOfficials': [{'name': 'Sunil Agrawal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a exploratory study at this point.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sunil Agrawal', 'investigatorAffiliation': 'Columbia University'}}}}