Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-03 @ 2:14 PM
Study NCT ID:
NCT03293095
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2017-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Task Kinematic in Musculoskeletal Pathology.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-28', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinematic analysis by motion sensor', 'timeFrame': '1 hour', 'description': 'A smartphone will pick up positioning, motion and acceleration information from the subject'}, {'measure': 'Kinematic analysis by 3D motion capture', 'timeFrame': '1 hour', 'description': 'The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task'}, {'measure': 'Responsiveness', 'timeFrame': '1 hour', 'description': 'The Responsiveness Box of COSMIN checklist will be used to determinate the response to change of the Smartphone and the 3D cameras. All possible items will be followed.'}], 'secondaryOutcomes': [{'measure': 'Quality of life questionnaire: EuroQoL 5D', 'timeFrame': '1 hour', 'description': 'standardized instrument for use as a measure of health outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['musculoskeletal pathology', 'motion sensor', 'motion capture', 'functional task', 'biomarker'], 'conditions': ['Musculoskeletal Disease']}, 'referencesModule': {'references': [{'pmid': '25546683', 'type': 'BACKGROUND', 'citation': 'Kilic G, Kilic E, Ozgocmen S. Relationship between psychiatric status, self-reported outcome measures, and clinical parameters in axial spondyloarthritis. Medicine (Baltimore). 2014 Dec;93(29):e337. doi: 10.1097/MD.0000000000000337.'}, {'pmid': '25440533', 'type': 'BACKGROUND', 'citation': 'Galan-Mercant A, Baron-Lopez FJ, Labajos-Manzanares MT, Cuesta-Vargas AI. Reliability and criterion-related validity with a smartphone used in timed-up-and-go test. Biomed Eng Online. 2014 Dec 2;13:156. doi: 10.1186/1475-925X-13-156.'}, {'pmid': '28241455', 'type': 'BACKGROUND', 'citation': 'Moreno FA, Merchan-Baeza JA, Gonzalez-Sanchez M, Gonzalez-Jimenez J, Cuesta-Vargas AI. Experimental Validation of Depth Cameras for the Parameterization of Functional Balance of Patients in Clinical Tests. Sensors (Basel). 2017 Feb 22;17(2):424. doi: 10.3390/s17020424.'}, {'pmid': '19638455', 'type': 'BACKGROUND', 'citation': 'van Weely SF, van Denderen CJ, van der Horst-Bruinsma IE, Nurmohamed MT, Dijkmans BA, Dekker J, Steultjens MP. Reproducibility of performance measures of physical function based on the BASFI, in ankylosing spondylitis. Rheumatology (Oxford). 2009 Oct;48(10):1254-60. doi: 10.1093/rheumatology/kep190. Epub 2009 Jul 28.'}, {'pmid': '12782991', 'type': 'BACKGROUND', 'citation': 'Fritz JM, Piva SR. Physical impairment index: reliability, validity, and responsiveness in patients with acute low back pain. Spine (Phila Pa 1976). 2003 Jun 1;28(11):1189-94. doi: 10.1097/01.BRS.0000067270.50897.DB.'}, {'pmid': '16550447', 'type': 'BACKGROUND', 'citation': 'van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.'}, {'pmid': '20169472', 'type': 'BACKGROUND', 'citation': 'Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.'}, {'pmid': '21094624', 'type': 'BACKGROUND', 'citation': "Dankaerts W, O'Sullivan P. The validity of O'Sullivan's classification system (CS) for a sub-group of NS-CLBP with motor control impairment (MCI): overview of a series of studies and review of the literature. Man Ther. 2011 Feb;16(1):9-14. doi: 10.1016/j.math.2010.10.006. Epub 2010 Nov 20."}, {'pmid': '8366262', 'type': 'BACKGROUND', 'citation': 'Myers AM, Holliday PJ, Harvey KA, Hutchinson KS. Functional performance measures: are they superior to self-assessments? J Gerontol. 1993 Sep;48(5):M196-206. doi: 10.1093/geronj/48.5.m196.'}, {'pmid': '26506612', 'type': 'BACKGROUND', 'citation': 'Roldan-Jimenez C, Bennett P, Cuesta-Vargas AI. Muscular Activity and Fatigue in Lower-Limb and Trunk Muscles during Different Sit-To-Stand Tests. PLoS One. 2015 Oct 27;10(10):e0141675. doi: 10.1371/journal.pone.0141675. eCollection 2015.'}, {'pmid': '33401131', 'type': 'DERIVED', 'citation': 'Trinidad-Fernandez M, Beckwee D, Cuesta-Vargas A, Gonzalez-Sanchez M, Moreno FA, Gonzalez-Jimenez J, Joos E, Vaes P. Differences in movement limitations in different low back pain severity in functional tests using an RGB-D camera. J Biomech. 2021 Feb 12;116:110212. doi: 10.1016/j.jbiomech.2020.110212. Epub 2020 Dec 27.'}, {'pmid': '32012763', 'type': 'DERIVED', 'citation': 'Trinidad-Fernandez M, Beckwee D, Cuesta-Vargas A, Gonzalez-Sanchez M, Moreno FA, Gonzalez-Jimenez J, Joos E, Vaes P. Validation, Reliability, and Responsiveness Outcomes Of Kinematic Assessment With An RGB-D Camera To Analyze Movement In Subacute And Chronic Low Back Pain. Sensors (Basel). 2020 Jan 27;20(3):689. doi: 10.3390/s20030689.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to create references values to patients with musculoskeletal pathology using functional tasks and measuring with a smartphone and video imaging (3D motion capture cameras).', 'detailedDescription': 'Musculoskeletal pathologies can affect bones, muscles, joints and other structures related to this system. These disorders are extremely common and can have an origin from autoimmune, inflammatory, traumatic, etc. The risk of developing this pathologies increases with age.\n\nThe diagnosis could delayed by lack of information, expensive assessment or difficult execution.\n\nCurrently, you can use a Smartphone to get the same information as sensors. In addition to Smartphone, 3D motion capture systems with a camera have been frequently used to analyse kinematics and are being integrated as a rehabilitation tool in patients. The use of Smartphones and 3D motion capture cameras would help to find fast and cheap assessment methods for professionals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treat in general care or diagnosed by a specialist.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons with diagnosis of musculoskeletal pathology.\n* Age between 20-65 años.\n* Subjects able to get up from the chair at least 5 times.\n* Be able to complete questionnaires and perform functional tasks.\n\nExclusion Criteria:\n\n* Subjects who are participating in a study with an experimental treatment.\n* Severe cardiovascular disease.\n* Being pregnant, in case of women.'}, 'identificationModule': {'nctId': 'NCT03293095', 'briefTitle': 'Functional Task Kinematic in Musculoskeletal Pathology.', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaga'}, 'officialTitle': 'Functional Task Kinematic in Patient With Musculoskeletal Pathology.', 'orgStudyIdInfo': {'id': 'iBAFI01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute musculoskeletal pathology patients', 'description': 'Musculoskeletal pathology patients that they will perform functional tasks measuring with motion sensors and motion capture.', 'interventionNames': ['Procedure: Standard Care']}, {'label': 'Match control', 'description': 'Healthy people of the same age as the acute musculoskeletal pathology subjects. They will perform functional tasks measuring with motion sensors and motion capture.', 'interventionNames': ['Procedure: Standard Care']}], 'interventions': [{'name': 'Standard Care', 'type': 'PROCEDURE', 'description': 'The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.', 'armGroupLabels': ['Acute musculoskeletal pathology patients', 'Match control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29009', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Malaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Antonio I Cuesta-Vargas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaga'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaga', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Dr. Antonio I Cuesta-Vargas', 'investigatorAffiliation': 'University of Malaga'}}}}