Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-21 @ 4:32 AM
Study NCT ID:
NCT03159767
Status:
COMPLETED
Last Update Posted:
2019-01-02
First Post:
2017-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Each physiotherapist rater will have to independently attach the sensors to the participant's spine before testing, and no positioning marks will be left on the patient in between tests or between visits. They will work in different rooms and will not have access to earlier results."}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Clinimetric study comparing repeated standardised spinal mobility test protocols by two independent raters on two occasions'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-28', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-rater reliability for measurement of lumbar spine range of movement', 'timeFrame': '2 weeks', 'description': 'ICC for lumbar side flexion and forward flexion expected to be \\>0.8'}], 'secondaryOutcomes': [{'measure': 'Inter-rater reliability for measurement of lumbar spine rotational range of movement', 'timeFrame': '2 weeks', 'description': 'ICC for spinal rotation expected to be \\>0.8'}, {'measure': 'Reliability of IMU metrology index non-inferior to reliability of BASMI', 'timeFrame': '2 weeks', 'description': 'Measurements obtained using IMUs are at least as reliable as the BASMI tape measure test'}, {'measure': 'Correlation with BASDAI: IMU metrology index non-inferior compared to BASMI', 'timeFrame': '2 weeks', 'description': 'We will compare the metrology indices in the strength of correlation with the BASDAI components of pain and stiffness.'}, {'measure': 'Inter-rater reliability for measurement of cervical rotation range of movement', 'timeFrame': '2 weeks', 'description': 'ICC for cervical rotation expected to be \\>0.8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis', 'Axial Spondyloarthritis']}, 'descriptionModule': {'briefSummary': 'This is a clinimetric study to validate the use of IMU spinal sensors to measure the range of spinal movement in a group of patients with axial spondyloarthritis.', 'detailedDescription': 'One of the most important goals of therapy in axial spondyloarthritis is to improve and/or preserve spinal mobility. In the early stages of the disease, spinal stiffness is reversible but eventually the spine can fuse causing permanent loss of flexion. Traditional tests for spinal mobility using tape measures are inaccurate and do not capture many aspects of kinematics such as spinal rotation or speed of movement. There is also a need for wearable sensors to give patients feedback and encourage more regular exercise.\n\nThe investigators will be using IMU spinal sensors to measure spinal ROM in a group of 40 patients with axial spondyloarthritis. The investigators will be testing aspects of inter-rater and intra-rater reliability, comparing sensor reliability to the accuracy of the traditional tape measure test (BASMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Confirmed diagnosis of axSpA according to the ASAS criteria\n\nExclusion Criteria:\n\n* Severe joint or spinal pain at the time of the study\n* Severely restricted hip movement\n* History of previous vertebral fracture\n* History of previous spinal surgery\n* Major scoliosis deformity\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03159767', 'briefTitle': 'A Clinimetric Test of Spinal Sensors in Measuring Spinal Mobility in Axial Spondyloarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Western Health and Social Care Trust'}, 'officialTitle': 'Validation of a New Method of Measuring Spinal Flexibility in Axial Spondyloarthritis Using Inertial Motion (IMU) Sensors', 'orgStudyIdInfo': {'id': 'WT 15/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Mobility Measurement: Rater A', 'description': 'All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.', 'interventionNames': ['Device: ViMove Spinal Sensor']}, {'type': 'EXPERIMENTAL', 'label': 'Spinal Mobility Measurement: Rater B', 'description': 'All patients will undergo the same ViMove Spinal Sensor measurement protocol with independent raters.', 'interventionNames': ['Device: ViMove Spinal Sensor']}], 'interventions': [{'name': 'ViMove Spinal Sensor', 'type': 'DEVICE', 'description': 'Sensors will be used to measure spinal movement', 'armGroupLabels': ['Spinal Mobility Measurement: Rater A', 'Spinal Mobility Measurement: Rater B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT47 6SB', 'city': 'Londonderry', 'state': 'N.Ireland', 'country': 'United Kingdom', 'facility': 'Department of Rheumatology, Altnagelvin Hospital', 'geoPoint': {'lat': 54.9981, 'lon': -7.30934}}], 'overallOfficials': [{'name': 'Philip Gardiner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western HSCT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Philip Gardiner', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Ulster', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Rheumatologist', 'investigatorFullName': 'Dr Philip Gardiner', 'investigatorAffiliation': 'Western Health and Social Care Trust'}}}}