Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 5:33 AM
Study NCT ID:
NCT01188161
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2010-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Effects of Being Rotated in a Whole Body Gyroscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-23', 'studyFirstSubmitDate': '2010-08-20', 'studyFirstSubmitQcDate': '2010-08-23', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computerized Dynamic Posturography', 'timeFrame': '10 minutes after Rotation', 'description': 'Standard platform posturography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Posturography', 'Balance', 'Falls', 'Gyroscope', 'Rotational Chair', 'Vestibular', 'Movement Disorders'], 'conditions': ['Falls', 'Balance', 'Movement Disorders']}, 'descriptionModule': {'briefSummary': 'Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec. The effects of this rotation on the ability to stand upright will be measured.', 'detailedDescription': 'Computerized dynamic posturography (CDP) testing will be obtained after practice sessions on all subjects using a CAPS Pro system (Vestibular Technologies, Cheyenne WY, USA). All tests will be conducted with the subject standing on a perturbing foam cushion. Six different conditions will be tested in sequence without the subjects stepping away from the foam/platform in order to assess if the center of sway position changed with the changing test conditions: (1) Eyes Open Head Neutral, (2) Eyes Closed Head Neutral, (3) Eyes Closed Head Right, (4) Eyes Closed Head Left, (5) Eyes Closed Head Flexed, (6) Eyes Closed Head Extended. Subjects will be continuously rotated in a computer-controlled multi-axis chair (Gyrostim by UltraThera Technologies, Inc.) in combinations of whole body Pitch and Yaw simultaneously over a 40 second profile at 90 deg/sec (15 RPM). The acceleration rates to 90 degrees per second as well as deceleration rates will be linear and occur in 1 second. We will utilize rotations that will represent all combinations of pitch and yaw with Pitch direction changing two times and Yaw direction four times (Backward Pitch -20 seconds with right Yaw-10 seconds to left Yaw-10 seconds, to Forward Pitch- 20 seconds with right Yaw-10 seconds to left Yaw 10 seconds). Post rotational CDP testing will be compared to the Pre Rotational CDP,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal healthy volunteers without a history of vertigo or dizziness', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal Healthy Adults without a history of vertigo or dizziness\n\nExclusion Criteria:\n\n* History of dizziness or vertigo'}, 'identificationModule': {'nctId': 'NCT01188161', 'acronym': 'Gyro', 'briefTitle': 'Postural Effects of Being Rotated in a Whole Body Gyroscope', 'organization': {'class': 'OTHER', 'fullName': 'Carrick Institute for Graduate Studies'}, 'officialTitle': 'The Effects of Whole Body Rotations in the Pitch and Yaw Planes on Postural Stability', 'orgStudyIdInfo': {'id': '1-2010-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal subjects', 'description': 'Volunteers without a history of dizzyness or vertigo', 'interventionNames': ['Device: Rotating Chair']}], 'interventions': [{'name': 'Rotating Chair', 'type': 'DEVICE', 'otherNames': ['gyrostim'], 'description': 'Subjects will be spun in rotating chair', 'armGroupLabels': ['Normal subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Life University', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}], 'overallOfficials': [{'name': 'Stephanie Sullivan, DC', 'role': 'STUDY_CHAIR', 'affiliation': 'Life University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carrick Institute for Graduate Studies', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Frederick Carrick', 'oldOrganization': 'Carrick Institute for Graduate Studies'}}}}