<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293095</url>
  </required_header>
  <id_info>
    <org_study_id>iBAFI01</org_study_id>
    <nct_id>NCT03293095</nct_id>
  </id_info>
  <brief_title>Functional Task Kinematic in Musculoskeletal Pathology.</brief_title>
  <official_title>Functional Task Kinematic in Patient With Musculoskeletal Pathology.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vrije Universiteit Brussel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Malaga</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this project is to create references values to patients with musculoskeletal&#xD;
      pathology using functional tasks and measuring with a smartphone and video imaging (3D motion&#xD;
      capture cameras).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Musculoskeletal pathologies can affect bones, muscles, joints and other structures related to&#xD;
      this system. These disorders are extremely common and can have an origin from autoimmune,&#xD;
      inflammatory, traumatic, etc. The risk of developing this pathologies increases with age.&#xD;
&#xD;
      The diagnosis could delayed by lack of information, expensive assessment or difficult&#xD;
      execution.&#xD;
&#xD;
      Currently, you can use a Smartphone to get the same information as sensors. In addition to&#xD;
      Smartphone, 3D motion capture systems with a camera have been frequently used to analyse&#xD;
      kinematics and are being integrated as a rehabilitation tool in patients. The use of&#xD;
      Smartphones and 3D motion capture cameras would help to find fast and cheap assessment&#xD;
      methods for professionals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematic analysis by motion sensor</measure>
    <time_frame>1 hour</time_frame>
    <description>A smartphone will pick up positioning, motion and acceleration information from the subject</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinematic analysis by 3D motion capture</measure>
    <time_frame>1 hour</time_frame>
    <description>The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Responsiveness</measure>
    <time_frame>1 hour</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire: EuroQoL 5D</measure>
    <time_frame>1 hour</time_frame>
    <description>standardized instrument for use as a measure of health outcome</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Musculoskeletal Disease</condition>
  <arm_group>
    <arm_group_label>Acute musculoskeletal pathology patients</arm_group_label>
    <description>Musculoskeletal pathology patients that they will perform functional tasks measuring with motion sensors and motion capture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Match control</arm_group_label>
    <description>Healthy people of the same age as the acute musculoskeletal pathology subjects. They will perform functional tasks measuring with motion sensors and motion capture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.</description>
    <arm_group_label>Acute musculoskeletal pathology patients</arm_group_label>
    <arm_group_label>Match control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treat in general care or diagnosed by a specialist.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with diagnosis of musculoskeletal pathology.&#xD;
&#xD;
          -  Age between 20-65 años.&#xD;
&#xD;
          -  Subjects able to get up from the chair at least 5 times.&#xD;
&#xD;
          -  Be able to complete questionnaires and perform functional tasks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are participating in a study with an experimental treatment.&#xD;
&#xD;
          -  Severe cardiovascular disease.&#xD;
&#xD;
          -  Being pregnant, in case of women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio I Cuesta-Vargas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Malaga</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malaga</name>
      <address>
        <city>Málaga</city>
        <zip>29009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>25546683</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25440533</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28241455</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19638455</PMID>
  </reference>
  <reference>
    <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. doi: 10.1097/01.BRS.0000067270.50897.DB.</citation>
    <PMID>12782991</PMID>
  </reference>
  <reference>
    <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(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.</citation>
    <PMID>16550447</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20169472</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21094624</PMID>
  </reference>
  <reference>
    <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. doi: 10.1093/geronj/48.5.m196.</citation>
    <PMID>8366262</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26506612</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Dr. Antonio I Cuesta-Vargas</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>musculoskeletal pathology</keyword>
  <keyword>motion sensor</keyword>
  <keyword>motion capture</keyword>
  <keyword>functional task</keyword>
  <keyword>biomarker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293095
org study id: iBAFI01
nct id: NCT03293095
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Kinematic analysis by motion sensor
time frame: 1 hour
description: A smartphone will pick up positioning, motion and acceleration information from the subject
measure: Kinematic analysis by 3D motion capture
time frame: 1 hour
description: The camera will perform a motion capture of the functional task. This system will calculate the displacement and the time of the functional task
measure: Responsiveness
time frame: 1 hour
description: 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.
measure: Quality of life questionnaire: EuroQoL 5D
time frame: 1 hour
description: standardized instrument for use as a measure of health outcome
arm group label: Acute musculoskeletal pathology patients
description: Musculoskeletal pathology patients that they will perform functional tasks measuring with motion sensors and motion capture.
arm group label: Match control
description: Healthy people of the same age as the acute musculoskeletal pathology subjects. They will perform functional tasks measuring with motion sensors and motion capture.
intervention type: Procedure
intervention name: Standard Care
description: The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.
arm group label: Acute musculoskeletal pathology patients
arm group label: Match control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antonio I Cuesta-Vargas, PhD
role: Principal Investigator
affiliation: University of Malaga
facility: 
country: Spain
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.
PMID: 25546683
citation: 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: 25440533
citation: 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: 28241455
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.
PMID: 19638455
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. doi: 10.1097/01.BRS.0000067270.50897.DB.
PMID: 12782991
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(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
PMID: 16550447
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.
PMID: 20169472
citation: 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: 21094624
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. doi: 10.1093/geronj/48.5.m196.
PMID: 8366262
citation: 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: 26506612
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Dr. Antonio I Cuesta-Vargas
investigator title: PhD
mesh term: Musculoskeletal Diseases
sharing ipd: No