NCT03293095

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 29, 2020

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

September 21, 2017

Last Update Submit

September 28, 2020

Conditions

Keywords

musculoskeletal pathologymotion sensormotion capturefunctional taskbiomarker

Outcome Measures

Primary Outcomes (3)

  • Kinematic analysis by motion sensor

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

    1 hour

  • 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

    1 hour

  • 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.

    1 hour

Secondary Outcomes (1)

  • Quality of life questionnaire: EuroQoL 5D

    1 hour

Study Arms (2)

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

Standard CarePROCEDURE

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

Acute musculoskeletal pathology patientsMatch control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treat in general care or diagnosed by a specialist.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaga

Málaga, 29009, Spain

Location

Related Publications (12)

  • 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: 25546683BACKGROUND
  • 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: 25440533BACKGROUND
  • 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: 28241455BACKGROUND
  • 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: 19638455BACKGROUND
  • 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: 12782991BACKGROUND
  • 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: 16550447BACKGROUND
  • 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: 20169472BACKGROUND
  • 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: 21094624BACKGROUND
  • 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: 8366262BACKGROUND
  • 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: 26506612BACKGROUND
  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Antonio I Cuesta-Vargas, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

March 1, 2018

Primary Completion

February 1, 2020

Study Completion

September 1, 2020

Last Updated

September 29, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations