Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-02 @ 12:05 PM
Study NCT ID:
NCT03988751
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2019-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Real-time Location System Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cjclark@wakehealth.edu', 'phone': '335-480-8064', 'title': 'Dr. Clancy Clark', 'organization': 'Wake Forest University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Continuous Ambulation', 'description': 'The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Interval Ambulation', 'description': 'The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuous Ambulation', 'description': 'The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.'}, {'id': 'OG001', 'title': 'Interval Ambulation', 'description': 'The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who completed 40 meter ambulation without adverse event or significant change in vital signs'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuous Ambulation', 'description': 'The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.'}, {'id': 'FG001', 'title': 'Interval Ambulation', 'description': 'The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuous Ambulation', 'description': 'The subject will walk a total distance of 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants.'}, {'id': 'BG001', 'title': 'Interval Ambulation', 'description': 'The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.'}, {'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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '63', 'upperLimit': '68'}, {'value': '64', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '65'}, {'value': '64', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', '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': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-30', 'size': 206695, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-21T18:44', 'hasProtocol': True}, {'date': '2017-06-15', 'size': 135396, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-21T18:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2019-06-12', 'resultsFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-18', 'studyFirstPostDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.', 'timeFrame': '1 day', 'description': 'Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Mobility']}, 'descriptionModule': {'briefSummary': 'The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.\n\nIn this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Male or female patients between the ages of 18 and 90.\n* Admitted to the Surgical Ward.\n* Recovering from surgery.\n* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.\n* Ability to understand and complete the study survey instruments in English.\n\nExclusion criteria\n\n* Non-surgical patient.\n* Emergency surgical procedure.\n* Anticipated discharge less than 24 hour.\n* Unable to ambulate or ambulation not permitted by treating provider.\n* Unable to understand and complete the study survey instruments in English.\n* Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.'}, 'identificationModule': {'nctId': 'NCT03988751', 'briefTitle': 'Real-time Location System Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Real-time Location System Feasibility Study Part 2', 'orgStudyIdInfo': {'id': 'IRB00039439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Ambulation', 'description': 'The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants', 'interventionNames': ['Behavioral: Ambulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interval Ambulation', 'description': 'The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.', 'interventionNames': ['Behavioral: Ambulation']}], 'interventions': [{'name': 'Ambulation', 'type': 'BEHAVIORAL', 'description': 'Variation in ambulatory intensity.', 'armGroupLabels': ['Continuous Ambulation', 'Interval Ambulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center of Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}