Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-02 @ 12:35 AM
Study NCT ID:
NCT03032393
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2017-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Power Posing on Timed Up and Go Test Score
Sponsor:
Organization:
Raw JSON
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For each participant, adverse event will be assessed for 1 day when the data collection is taken.', 'eventGroups': [{'id': 'EG000', 'title': 'Dominant', 'description': 'high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Submissive', 'description': 'low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Timed up and go Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dominant', 'description': 'high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.'}, {'id': 'OG001', 'title': 'Submissive', 'description': 'low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).', 'description': 'Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.\n\nA change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.', 'unitOfMeasure': 'second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dominant', 'description': 'high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.'}, {'id': 'FG001', 'title': 'Submissive', 'description': 'low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dominant', 'description': 'high-power: Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.'}, {'id': 'BG001', 'title': 'Submissive', 'description': 'low-power: Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-13', 'size': 60836, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-01-09T15:21', 'hasProtocol': False}, {'date': '2020-06-02', 'size': 33880, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-02T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2017-01-20', 'resultsFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed up and go Test', 'timeFrame': 'Up to 3 minutes during each Timed up and go Test. Twice (pre and post the postural intention) at the same session (day).', 'description': 'Patients wear their regular footwear and can use a walking aid if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters or 10 feet away on the floor. The timed up and go test measures the amount of time, in seconds, that it takes to stand from a chair, walk 3 meters, turn around and walk back to the chair, and sit down again.\n\nA change between pre and post postural intervention is reported. The time point for pre intervention is at baseline. The time point for post intervention is immediately after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This study determines the effects of posture on time up and go test. Half of the subjects will assume a high-power posture, while the other half will assume a low-power posture.', 'detailedDescription': 'Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately one foot apart for 20 seconds. Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 seconds. Timed Up and Go test was administered using an OmniVR™ Virtual Rehabilitation System before and after the postural intervention'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, age 18 to 65, with all 4 extremities intact, and ability to stand still for 20 seconds.\n\nExclusion Criteria:\n\n* unable to stand with their feet together or one foot apart for at least 20 seconds, unable to wrap their arms around their torso or keep their hands on their hips for 20 seconds, unable to perform sit to stand transfer and ambulation independently, and cognitive impairments that interfere with the experimental procedures.'}, 'identificationModule': {'nctId': 'NCT03032393', 'briefTitle': 'The Effect of Power Posing on Timed Up and Go Test Score', 'organization': {'class': 'OTHER', 'fullName': 'Youngstown State University'}, 'officialTitle': 'The Effects of Posture on Timed up and go', 'orgStudyIdInfo': {'id': '071-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dominant', 'description': 'Subjects in the experimental group were instructed to stand with hands on their hips, elbows pointing out and feet approximately one foot apart for 20 seconds.', 'interventionNames': ['Other: high-power']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Submissive', 'description': 'Subjects in the control group were instructed to stand with hands and arms wrapping around the torso and feet together for 20 seconds.', 'interventionNames': ['Other: low-power']}], 'interventions': [{'name': 'high-power', 'type': 'OTHER', 'description': 'Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.', 'armGroupLabels': ['Dominant']}, {'name': 'low-power', 'type': 'OTHER', 'description': 'Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.', 'armGroupLabels': ['Submissive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44555', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Youngstown State University', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}], 'overallOfficials': [{'name': 'Michael Hripko', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Youngstown State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Youngstown State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Weiqing Ge', 'investigatorAffiliation': 'Youngstown State University'}}}}