- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03293095
Functional Task Kinematic in Musculoskeletal Pathology.
Functional Task Kinematic in Patient With Musculoskeletal Pathology.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
The diagnosis could delayed by lack of information, expensive assessment or difficult execution.
Currently, 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Málaga, Spanien, 29009
- Malaga
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Persons with diagnosis of musculoskeletal pathology.
- Age between 20-65 años.
- Subjects able to get up from the chair at least 5 times.
- Be able to complete questionnaires and perform functional tasks.
Exclusion Criteria:
- Subjects who are participating in a study with an experimental treatment.
- Severe cardiovascular disease.
- Being pregnant, in case of women.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Acute musculoskeletal pathology patients
Musculoskeletal pathology patients that they will perform functional tasks measuring with motion sensors and motion capture.
|
The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.
|
|
Match control
Healthy people of the same age as the acute musculoskeletal pathology subjects.
They will perform functional tasks measuring with motion sensors and motion capture.
|
The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Kinematic analysis by motion sensor
Tidsramme: 1 hour
|
A smartphone will pick up positioning, motion and acceleration information from the subject
|
1 hour
|
|
Kinematic analysis by 3D motion capture
Tidsramme: 1 hour
|
The camera will perform a motion capture of the functional task.
This system will calculate the displacement and the time of the functional task
|
1 hour
|
|
Responsiveness
Tidsramme: 1 hour
|
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.
|
1 hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life questionnaire: EuroQoL 5D
Tidsramme: 1 hour
|
standardized instrument for use as a measure of health outcome
|
1 hour
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Antonio I Cuesta-Vargas, PhD, University of Malaga
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- iBAFI01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Muskuloskeletal sygdom
-
Children's HealthTheranicaIkke rekrutterer endnuAmplified Musculoskeletal Pain Syndrome (AMPS)Forenede Stater
-
Children's Hospital Medical Center, CincinnatiAktiv, ikke rekrutterendeLændesmerter | Kronisk udbredt smerte | Fibromyalgi | Kompleks regionalt smertesyndrom (CRPS) | Ehlers-Danlos syndrom (EDS) | Amplified Musculoskeletal Pain Syndrome (AMPS)Forenede Stater
Kliniske forsøg med Standard Care
-
Beijing BiotechRekrutteringEpitelial ovariecancer | Æggelederkarcinom | Primært peritonealt karcinom | Recidiverende eller refraktær sygdom efter standardbehandlingerKina
-
The First Affiliated Hospital of Air Force Medicial...RekrutteringRefraktær membranøs nefropatiKina
-
Xuanwu Hospital, BeijingBioray LaboratoriesIkke rekrutterer endnuMultipel sclerose | Neuromyelitis Optica Spectrum Disorders | Kronisk inflammatorisk demyeliniserende polyradiculoneuropati | Myasthenia Gravis, generaliseretKina
-
The Second Hospital of Shandong UniversityAktiv, ikke rekrutterende
-
The Second Hospital of Shandong UniversityAktiv, ikke rekrutterendeSikkerhed og effektivitet af cellulære lægemidler, objektiv responsrate for forsøgspersoner osvKina
-
Cellular Biomedicine Group Ltd.The First Affiliated Hospital with Nanjing Medical UniversityAfsluttetRefraktært diffust stort B-cellet lymfomKina
-
Baylor College of MedicineThe Methodist Hospital Research Institute; Center for Cell and Gene Therapy...RekrutteringKronisk lymfatisk leukæmi | Non-Hodgkin lymfom | Akut lymfatisk leukæmiForenede Stater
-
Zhejiang UniversityCarbiogene Therapeutics Co. Ltd.RekrutteringKlinisk forsøg med autologe GPC3 CAR-T-celler (CBG166) terapi for avanceret hepatocellulært karcinomAvanceret hepatocellulært karcinomKina
-
Nexcella Inc.Immix Biopharma, Inc.RekrutteringLet kæde (AL) amyloidoseForenede Stater
-
Second Affiliated Hospital, School of Medicine,...RekrutteringRecidiverende og refraktær B-celle lymfomKina