Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04515693
Status:
TERMINATED
Last Update Posted:
2022-07-19
First Post:
2020-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Due to COVID there were limitations is performing study activities and it was decided to terminate the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2020-08-14', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minute walk test', 'timeFrame': '8 minutes (2 minutes for set-up, 6 minutes to execute)', 'description': 'walking endurance assessment measured in meters of total distance completed over 6 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years old\n* Primary diagnosis of an acute or hemorrhagic stroke\n* Admitted into the acute or acute rehab setting and is appropriate for physical therapy services.\n* Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation.\n* Can stand and/or ambulate for at least 6 minutes\n\nExclusion Criteria:\n\n* Hemodynamically unstable\n* Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok)\n* Patients with bilateral acute stroke\n* Patients who are unable to follow 1 step commands as determined by the screening physiatrist\n* Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury\n* Any other condition that would limit a patient's ability to remain in a standing position with assistance for 6 minutes at a time."}, 'identificationModule': {'nctId': 'NCT04515693', 'briefTitle': 'Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population', 'orgStudyIdInfo': {'id': '19-010067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maximal Assist group', 'description': 'Subjects with acute stroke who ambulate with Maximal assistance of 1.', 'interventionNames': ['Other: 6 Minutes Walking Test']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Assist group', 'description': 'Subjects with acute stroke who ambulate with Moderate assistance of 1.', 'interventionNames': ['Other: 6 Minutes Walking Test']}, {'type': 'EXPERIMENTAL', 'label': 'Minimal Assist group', 'description': 'Subjects with acute stroke who ambulate with Minimal assistance of 1.', 'interventionNames': ['Other: 6 Minutes Walking Test']}, {'type': 'EXPERIMENTAL', 'label': 'Supervision/Modified Independence/Independence', 'description': 'Subjects who walk without physical assistance of a helper.', 'interventionNames': ['Other: 6 Minutes Walking Test']}], 'interventions': [{'name': '6 Minutes Walking Test', 'type': 'OTHER', 'description': 'A walkway of 12 meters will be marked with one cone at each end. The patient will be instructed to walk back and forth as many times as possible in six minutes.', 'armGroupLabels': ['Maximal Assist group', 'Minimal Assist group', 'Moderate Assist group', 'Supervision/Modified Independence/Independence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Hannah Karstetter, PT, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Physical Therapy', 'investigatorFullName': 'Megan C. Eikenberry, P.T., D.P.T.', 'investigatorAffiliation': 'Mayo Clinic'}}}}