Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT03604367
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI protocols will measure neural function activity during active bipedal movement in healthy volunteers', 'timeFrame': 'Duration of the study, approximately 1 year', 'description': 'Determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in healthy volunteers.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fMRI', 'BOLD Signal', 'Rehabilitation'], 'conditions': ['Stroke', 'Motor Activity']}, 'descriptionModule': {'briefSummary': 'Less than 50% of stroke survivors progress to independent community ambulation. Even among the stroke survivors who achieve independent ambulation, significant residual deficits persist in balance and gait speed, with 60% of persons post-stroke reporting limitations in mobility related to walking.Consequently maximizing recovery of locomotor function is the focus of neurorehabilitation efforts worldwide. A recently completed clinical trial from members of this investigative team demonstrated that 6 weeks of treadmill training elicits substantial improvements in over ground walking speed and symmetry in persons following stroke. Consistent with the goals of the South Carolina Stroke Rehabilitation Research Center (SCSRRC) and NIH Brain Initiative, the investigators now plan to investigate the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients. Although previous investigators have assessed neural activity during simulated walking using motor imagery, motor imagery does not simulate the typical sensory feedback associated with active movement. To move the field forward, it is necessary to measure active bipedal movement in the MR-environment in healthy volunteers, before moving forward in stroke patients.', 'detailedDescription': 'The overarching goal of this Discovery Proposal is to evaluate neural activity during unipedal and bipedal movement in a cohort of healthy individuals (Aim 1).\n\nThe rigor and reproducibility will be evaluated by comparing the results of 1) active movement -Bipedal with 2) active movement -unipedal 4 and 3) imagined movement.\n\nDependent measures include: 1) head motion during the fMRI task, 2) BOLD signal in the ipsilateral and contralateral motor cortex during the fMRI task, 3) force applied during the fMRI task, and 4) participant feedback using a modified version of the Presence Questionnaire (a standard tool to assess ecological validity of virtual environments.\n\nEach Aim has a development and evaluation aspect. Through this 1 year proposal the investigators will determine if the bipedal fMRI protocol (active movement) is able to engage neural networks more robustly (e.g. greater effect size) than bipedal imagery alone in Healthy Volunteers.\n\nSpecific Aim #1: Healthy volunteers: The investigators will test the hypothesis that with active bipedal movement there will be 1) no difference in head movement, but 2) greater motor cortex BOLD signal, 3) smoother force exchange between the feet, 4) higher participant satisfaction than unipedal movement or motor imagery alone. This sample size was selected based on a prior publication of imagined movement. The outcome of this aim may result in the first publication in the field to evaluate bipedal movement in an MR-environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers will be screened for eligibility who are right hand dominant.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 21-65\n* Right hand dominant\n* Able to read and understand questionnaires and informed consent\n\nExclusion criteria:\n\n* Self reported history of cardiac disease, COPD or oxygen dependence, neurological and psychiatric disorders, dementia or previous stroke, major head trauma, severe visual impairment, osteoarthritis, orthopedic problems that limit passive range of motion, illegal drug or alcohol dependence, claustrophobia\n* Non-mri compatible metal implants in the body\n* Pregnant females'}, 'identificationModule': {'nctId': 'NCT03604367', 'briefTitle': 'Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Gait Mate: Examining Neural Networks Engaged During Lower Extremity Movement in the MRI', 'orgStudyIdInfo': {'id': '72777'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GAITRite assessment', 'description': 'Subjects will undergo the GAITRite assessment of functional walking and then complete the Functional MRI Bipedal paradigm followed by questionnaires and assessments regarding the virtual environment.', 'interventionNames': ['Device: GAITRite assessment']}], 'interventions': [{'name': 'GAITRite assessment', 'type': 'DEVICE', 'otherNames': ['fMRI Bipedal Paradigm'], 'description': 'The fMRI Bipedal Paradigm will allow investigators to study the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients.', 'armGroupLabels': ['GAITRite assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Colleen A Hanlon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available immediately after first publication of the results. This is estimated to be at the end of 2019.', 'ipdSharing': 'YES', 'description': 'The data from the primary outcome measurement will be shared via manuscripts and after study completion by request to the Principal Investigator.', 'accessCriteria': 'Interested parties should contact the Principal Investigator directly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'MUSC Center for Biomedical Research Excellence (COBRE) in Stroke Recovery', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}