Functional Task Kinematic in Musculoskeletal Pathology.

Musculoskeletal Disease Clinical Trial

Official title:

Functional Task Kinematic in Patient With Musculoskeletal Pathology.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293095
• Other study ID #: iBAFI01
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: July 2019
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Disease
• Musculoskeletal Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Malaga	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Vrije Universiteit Brussel

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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. Review. — View 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. — View Citation

Galán-Mercant A, Barón-López 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. — View 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. — View 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. — View Citation

Moreno FÁ, Merchán-Baeza JA, González-Sánchez M, González-Jiménez 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). pii: E424. doi: 10.3390/s17020424. — View 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. — View Citation

Roldán-Jiménez 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. — View 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:S169-91. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic analysis by motion sensor	A smartphone will pick up positioning, motion and acceleration information from the subject	1 hour
Primary	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
Primary	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	Quality of life questionnaire: EuroQoL 5D	standardized instrument for use as a measure of health outcome	1 hour