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CompletedNCT03293095Updated Sep 29, 2020

Functional Task Kinematic in Musculoskeletal Pathology.

An observational study in Musculoskeletal Disease, sponsored by University of Malaga. Completed at 1 site in Spain. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by University of Malaga · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
20 Years to 65 Years
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Musculoskeletal Disease

Keywords

  • musculoskeletal pathology
  • motion sensor
  • motion capture
  • functional task
  • biomarker
03

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients treat in general care or diagnosed by a specialist.

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

Exclusion Criteria:

  • Subjects who are participating in a study with an experimental treatment.
  • Severe cardiovascular disease.
  • Being pregnant, in case of women.
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute musculoskeletal pathology patients

    Musculoskeletal pathology patients that they will perform functional tasks measuring with motion sensors and motion capture.

    Procedure: 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.

    Procedure: Standard Care

Interventions

  • ProcedureStandard Care

    The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.

05

What researchers measure

Primary outcomes

  1. Kinematic analysis by motion sensor

    A smartphone will pick up positioning, motion and acceleration information from the subject

    Time frame: 1 hour

  2. Kinematic analysis by 3D motion capture

    The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task

    Time frame: 1 hour

  3. Responsiveness

    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.

    Time frame: 1 hour

Secondary outcomes

  1. Quality of life questionnaire: EuroQoL 5D

    standardized instrument for use as a measure of health outcome

    Time frame: 1 hour

06

Study locations

1 site
  • Malaga
    Málaga, 29009, Spain
07

References and documents

Publications

  • 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. PubMed 25546683 ↗
  • 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. PubMed 25440533 ↗
  • 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. PubMed 28241455 ↗
  • 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. PubMed 19638455 ↗
  • 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. PubMed 12782991 ↗
  • 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. PubMed 16550447 ↗
  • 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. PubMed 20169472 ↗
  • 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. PubMed 21094624 ↗
  • 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. PubMed 8366262 ↗
  • 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. PubMed 26506612 ↗
  • 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. PubMed 33401131 ↗
  • 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. PubMed 32012763 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03293095
Lead sponsor
University of Malaga
Collaborators
Vrije Universiteit Brussel
Responsible party
Dr. Antonio I Cuesta-Vargas (PhD, University of Malaga) — Principal investigator
First posted
Sep 26, 2017
Start date
Mar 1, 2018
Primary completion
Feb 1, 2020
Completion
Sep 1, 2020
Last update
Sep 29, 2020

Study contacts

Antonio I Cuesta-Vargas, PhD
principal investigator · University of Malaga

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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