Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:58 AM
Study NCT ID:
NCT04288960
Status:
SUSPENDED
Last Update Posted:
2022-05-26
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Covid and access to participants', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-19', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speed', 'timeFrame': '60 minutes', 'description': 'How quickly a participant walks overground'}, {'measure': 'Cadence', 'timeFrame': '60 minutes', 'description': 'Steps taken per minute'}, {'measure': 'Stride Length', 'timeFrame': '60 minutes', 'description': 'The distance between strides'}, {'measure': 'Swing phase duration', 'timeFrame': '60 minutes', 'description': 'Percentage of the gait cycle spent in swing phase'}, {'measure': 'Stance phase duration', 'timeFrame': '60 minutes', 'description': 'Percentage of the gait cycle spent in stance phase'}, {'measure': 'Gait cycle duration', 'timeFrame': '60 minutes', 'description': 'The time it takes to complete one gait cycle'}, {'measure': 'Double support duration', 'timeFrame': '60 minutes', 'description': 'Percentage of the gait cycle spend with both feet on the ground (double support)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'validity', 'gait'], 'conditions': ['Stroke', 'Gait, Hemiplegic']}, 'referencesModule': {'references': [{'pmid': '30747572', 'type': 'BACKGROUND', 'citation': 'De Ridder R, Lebleu J, Willems T, De Blaiser C, Detrembleur C, Roosen P. Concurrent Validity of a Commercial Wireless Trunk Triaxial Accelerometer System for Gait Analysis. J Sport Rehabil. 2019 Aug 1;28(6):jsr.2018-0295. doi: 10.1123/jsr.2018-0295.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to validate the G-walk for several gait parameters, tested against a gold standard three dimensional camera system. This research will inform researchers and practitioners as to whether the G-Walk is a suitable and valid tool to easily assess walking ability in people with chronic stroke.', 'detailedDescription': 'Twenty chronic stroke survivors will be recruited for this study from an independent neuro-physiotherapy practice and community exercise programme.Gait analysis will be used to look at several gait parameters through the use of a three-dimensional visual analysis system based in our Biomechanics Lab at the University of Winchester. Participants will attend testing one testing session of approximately 1 hour. During this testing session functional measures and walking trials will be assessed. Participants will first be asked to complete a set of simple movements that will contribute towards Fugl Meyer questionnaire. Twenty eight reflective markers will then be attached to specified joints and segments of the body, such as the thigh, with double sided sticky tape to allow for data collection through the camera system to collect kinematic data. The belt mounted accelerometer (G-Walk) will be positioned around the waist over the L5 vertebrae. Participants will be asked to perform 6 walking trials of 10m to collect 3D kinematic and accelerometer gait data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic stroke (\\<3month post stroke) will be recruited from a neuro-physiotherapy practice, community-based stroke support groups and community exercise programme. All participants would have been diagnosed with stroke by a specialist neurologist/stroke consultant from a UK National Health Service (NHS) Foundation Trust, and have undertaken normal inpatient and outpatient rehabilitation in accordance with NICE guidelines (National Institute of Health and CARE', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\<3 months post stroke\n* Lower limb impairment\n* Able to stand and step independently\n* Functional ambulation classifications (FAC) of 2-5\n* Modified Rankin Scale (MRS) of 1-3\n* Cognitively aware to undertake the testing session\n\nExclusion Criteria:\n\n* Unresolved deep vein thrombosis\n* unstable cardiovascular conditions\n* open wounds\n* active drug resistant infection\n* recent fractures of involved limb\n* peripheral arterial disease\n* incontinence\n* severe osteoporosis\n* non-weight bearing.'}, 'identificationModule': {'nctId': 'NCT04288960', 'briefTitle': 'Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Winchester'}, 'officialTitle': 'Validity of a Belt Mounted Accelerometer to Assess Walking Measures in Patients With Chronic Stroke', 'orgStudyIdInfo': {'id': 'Wright_Validity_GWalk'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Stroke', 'description': 'Twenty chronic stroke patients (\\>3months post-stroke) will complete a one off session in a biomechanics lab. This session will include the Fugl Meyer Questionnaire and several walking trials along a flat, level 10m walkway. During this participants will wear a belt mounted accelerometer and small reflective markers on joints.', 'interventionNames': ['Device: Gwalk accelerometer walking trials']}], 'interventions': [{'name': 'Gwalk accelerometer walking trials', 'type': 'DEVICE', 'description': 'No intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device', 'armGroupLabels': ['Chronic Stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO224NR', 'city': 'Winchester', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'University of Winchester', 'geoPoint': {'lat': 51.06513, 'lon': -1.3187}}], 'overallOfficials': [{'name': 'Amy Wright, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Winchester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share this information with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Winchester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}