- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293095
Functional Task Kinematic in Musculoskeletal Pathology.
Functional Task Kinematic in Patient With Musculoskeletal Pathology.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Málaga, Spain, 29009
- Malaga
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kinematic analysis by motion sensor
Time Frame: 1 hour
|
A smartphone will pick up positioning, motion and acceleration information from the subject
|
1 hour
|
Kinematic analysis by 3D motion capture
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life questionnaire: EuroQoL 5D
Time Frame: 1 hour
|
standardized instrument for use as a measure of health outcome
|
1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Antonio I Cuesta-Vargas, PhD, University of Malaga
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iBAFI01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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