<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/NCT03769220</url>
  </required_header>
  <id_info>
    <org_study_id>850/2018BO1</org_study_id>
    <nct_id>NCT03769220</nct_id>
  </id_info>
  <brief_title>Evaluation of the Measurement Properties of a 5 Time Repeated Instrumented Timed Up and Go (5iTUG)</brief_title>
  <acronym>5iTUG</acronym>
  <official_title>Protocol for the Method Study: Evaluation of the Measurement Properties of an Instrumented and Repeated Timed Up and Go (5iTUG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Robert Bosch Gesellschaft für Medizinische Forschung mbH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Robert Bosch Gesellschaft für Medizinische Forschung mbH</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to tailor interventions, objective assessments of physical function is needed. A&#xD;
      limitation of several of today's clinical assessments is that they require too much time&#xD;
      and/or space. The Timed Up and Go (TUG) is a commonly used clinical test of physical function&#xD;
      in older populations. The TUG is particularly useful due to its short administration time and&#xD;
      the little space that is required. The TUG is however of limited value when used in&#xD;
      higher-functioning older adults due to ceiling effects. Instrumented versions of TUG (iTUG)&#xD;
      computes several outcome measures in addition to the traditional outcome measure which is the&#xD;
      total duration. The aim of this study is to evaluate the construct- and discriminative&#xD;
      validity of outcomes derived from sensor signals recorded with a smartphone during a five&#xD;
      times repeated iTUG (5iTUG).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At &quot;Robert-Bosch-Krankenhaus&quot; (RBK) in Stuttgart the investigators aim to recruit a sample&#xD;
      consisting of 60 geriatric participants. The sample will recruited from a mix of health care&#xD;
      settings in order to allow for cohort specific analysis.&#xD;
&#xD;
      The first 20 participants will be recruited from the inpatient rehabilitation ward at RBK.&#xD;
      The treating medical doctor and Prof Dr Clemens Becker will inform potentially eligible&#xD;
      participants about the possibility of being involved in this study. Should participants&#xD;
      confirm their interest a research assistant will complete a detailed information session and&#xD;
      obtain written informed consent prior enrolment.&#xD;
&#xD;
      Further 20 participants will be recruited through the outpatient rehabilitation clinic at&#xD;
      RBK. The treating doctor will again inform the potential participant about the study and&#xD;
      invite them to 6 participate. A research assistant will complete a detailed information&#xD;
      session and written informed consent will be obtained prior enrolment.&#xD;
&#xD;
      Lastly 20 community dwelling older adults will be invited to participate. Recruitment will&#xD;
      occur through advertisement at a locally run seniors fitness group, conducted every Thursday&#xD;
      at RBK. Older adults who are interested in being involved will be invited to receive&#xD;
      additional information about the study and the involved procedures before providing written&#xD;
      informed consent and being enrolled.&#xD;
&#xD;
      All participation is entirely voluntary. Participants are free to withdraw at any time&#xD;
      without stating a reason. Withdrawal or non-participation will not impact the care and&#xD;
      services they are receiving or will receive from RBK now or in the future.&#xD;
&#xD;
      The following inclusion criteria will be used: community-dwelling, aged between 60 and 80&#xD;
      years and are able to walk 30m independently. Participants will be excluded if they report&#xD;
      any severe cardiovascular, pulmonary, neurological, or mental diseases.&#xD;
&#xD;
      In Trondheim researchers will recruit and include 20 healthy seniors, men and women, from&#xD;
      senior exercise groups in local fitness centres and the municipality of Trondheim. They will&#xD;
      approach leaders or instructors of the exercise groups and ask them to contact the&#xD;
      participants in their exercise groups to ask whether they want to take part in this study.&#xD;
      Those who are willing will be contacted by a research coordinator. Written informed consent&#xD;
      will be obtained prior enrolment.&#xD;
&#xD;
      Participants will be randomized to start with either the five times repeated instrumented&#xD;
      Time up an Go Test (5iTUG) or clinical tests. The clinical tests include seven tests: the&#xD;
      Community Balance and Mobility Scale (CBMS) (only the group of healthy participants), 8-level&#xD;
      Balance Scale, 30s Chair stand (CS), Five times sit-to-stand (STS), Short Physical&#xD;
      Performance Battery (SPPB), fast and habitual gait speed over 7 meters. Participants will&#xD;
      complete the clinical tests according to the current standard clinical procedures. For the&#xD;
      5iTUG, participants will be instructed to do the Time up and Go Test (TUG) five times with 30&#xD;
      seconds rest between each repetition. The assessor will tell the participant when they should&#xD;
      start walking. Participants will wear a smartphone attached with a belt to their lower back&#xD;
      during the entire test sequence, both during the clinical tests and the 5iTUG. The assessor&#xD;
      will demonstrate each test before the participants start. Participants can take breaks&#xD;
      between tests or trials if needed. The assessor is experienced with testing of physical&#xD;
      function in older adults, and will stand close to participants during all tasks especially&#xD;
      where balance is challenged. At the end of the test-session, the assessor will administer one&#xD;
      questionnaire about activities of daily living (ADL) function (the Late Life Function and&#xD;
      Disability (LLFDI) questionnaire) and cognitive impairment based on screening via the&#xD;
      Montreal Cognitive Assessment (MoCA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">September 16, 2019</completion_date>
  <primary_completion_date type="Actual">September 16, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>five time repeated instrumented time up and Go Test (5iTUG)</measure>
    <time_frame>Baseline</time_frame>
    <description>Discriminative ability of the 5iTUG compared to other clinical measurements (include acceleration, velocity, duration of movements, number of steps, and step variability, from the different sub-phases of the TUG test, such as sit-to-walk, walk, first/last turn, and walk-to-sit). By performing five repetitions of an instrumented TUG (5iTUG), it is possible to get features that are more sensitive from the instrument, in addition to in total five repetitions of sit-to-stand, turning, and turn-to-sit movements, along with a total of 30 meters of walking. The 5iTUG quantifies the movement characteristics from tasks that resembles those carried out in other independent clinical measurements and test batteries, such as the Five times sit-to-stand, gait assessments, and 30s chair stand. Variability repetitions within the trials will be analysed using a repeated measures analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>five time Sit to Stand (5xSTS)</measure>
    <time_frame>Baseline</time_frame>
    <description>needed time for 5 time repeated sit to stand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 seconds Chair Stand (30s CS)</measure>
    <time_frame>Baseline</time_frame>
    <description>30 seconds chair stand number of repetitions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gait speed</measure>
    <time_frame>Baseline</time_frame>
    <description>Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Balance and Mobility Scale (CBMS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Community Balance and Mobility Scale, Score range from 0-96 points (with 96 is the best performance), duration: 35 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>8-level balance score</measure>
    <time_frame>Baseline</time_frame>
    <description>8-level balance score, each balance position held for 15 seconds, test stopped when position can not be completed, scored out of 8, higher points indicate better performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery (SPPB)</measure>
    <time_frame>Baseline</time_frame>
    <description>Short Physical Performance Battery total and sub-scores, 3 balance tests each balance position held for 10 seconds, test stopped when position can not be completed, habitual gait speed over 4m, 5 time sit to stand, higher points indicate better performance, score range 0-12, duration: 8 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late Life Function and Disability questionnaire for Function (LLFDI)</measure>
    <time_frame>Baseline</time_frame>
    <description>Late Life Function and Disability (LLFDI) questionnaire, subjective measurement of functional ability and disability, scale range 0-100 points, higher points indicate better performance</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Measurement Properties of 5iTUG</condition>
  <condition>Physical Disability</condition>
  <condition>Balance</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Leg Strength</condition>
  <condition>Gait Disorder, Sensorimotor</condition>
  <condition>Activity of Daily Living</condition>
  <arm_group>
    <arm_group_label>inpatient rehabilitation ward</arm_group_label>
    <description>The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital (RBK). The treating medical doctor will inform potentially eligible participants about the possibility of being involved in this study. Should participants confirm their interest a research assistant will complete a detailed information session and obtain written informed consent prior enrolment.&#xD;
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>outpatient rehabilitation clinic</arm_group_label>
    <description>Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital (RBK). The treating doctor will again inform the potential participant about the study and invite them to participate. A research assistant will complete a detailed information session and written informed consent will be obtained prior enrolment.&#xD;
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>community dwelling older adults</arm_group_label>
    <description>Lastly 20 community dwelling older adults will be invited to participate. Recruitment will occur through advertisement at a locally run seniors fitness group, conducted every Thursday at RBK. Older adults who are interested in being involved will be invited to receive additional information about the study and the involved procedures before providing written informed consent and being enrolled.&#xD;
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The first 20 participants will be recruited from the inpatient rehabilitation ward at&#xD;
        Robert-Bosch-Hospital.&#xD;
&#xD;
        Further 20 participants will be recruited through the outpatient rehabilitation clinic at&#xD;
        Robert-Bosch-Hospital.&#xD;
&#xD;
        Lastly 20 community dwelling older adults will be invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  community-dwelling&#xD;
&#xD;
          -  aged between 60 and 80 years&#xD;
&#xD;
          -  are able to walk 30m independently&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any severe cardiovascular, pulmonary, neurological, or mental diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Robert-Bosch-Hospital</name>
      <address>
        <city>Stuttgart</city>
        <state>Baden-Württemberg</state>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. doi: 10.1046/j.1532-5415.2003.51104.x.</citation>
    <PMID>12588574</PMID>
  </reference>
  <reference>
    <citation>Podsiadlo D, Richardson S. The timed &quot;Up &amp; Go&quot;: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.</citation>
    <PMID>1991946</PMID>
  </reference>
  <reference>
    <citation>Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.</citation>
    <PMID>23350947</PMID>
  </reference>
  <reference>
    <citation>Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012 May;36(1):163-5. doi: 10.1016/j.gaitpost.2012.02.006. Epub 2012 Mar 14.</citation>
    <PMID>22421189</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Robert Bosch Gesellschaft für Medizinische Forschung mbH</investigator_affiliation>
    <investigator_full_name>Corinna Nerz</investigator_full_name>
    <investigator_title>Research associate/PhD Candidate</investigator_title>
  </responsible_party>
  <keyword>Time up and Go Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gait Disorders, Neurologic</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/NCT03769220
org study id: 850/2018BO1
nct id: NCT03769220
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In order to tailor interventions, objective assessments of physical function is needed. A
      limitation of several of today's clinical assessments is that they require too much time
      and/or space. The Timed Up and Go (TUG) is a commonly used clinical test of physical function
      in older populations. The TUG is particularly useful due to its short administration time and
      the little space that is required. The TUG is however of limited value when used in
      higher-functioning older adults due to ceiling effects. Instrumented versions of TUG (iTUG)
      computes several outcome measures in addition to the traditional outcome measure which is the
      total duration. The aim of this study is to evaluate the construct- and discriminative
      validity of outcomes derived from sensor signals recorded with a smartphone during a five
      times repeated iTUG (5iTUG).
At "Robert-Bosch-Krankenhaus" (RBK) in Stuttgart the investigators aim to recruit a sample
      consisting of 60 geriatric participants. The sample will recruited from a mix of health care
      settings in order to allow for cohort specific analysis.

      The first 20 participants will be recruited from the inpatient rehabilitation ward at RBK.
      The treating medical doctor and Prof Dr Clemens Becker will inform potentially eligible
      participants about the possibility of being involved in this study. Should participants
      confirm their interest a research assistant will complete a detailed information session and
      obtain written informed consent prior enrolment.

      Further 20 participants will be recruited through the outpatient rehabilitation clinic at
      RBK. The treating doctor will again inform the potential participant about the study and
      invite them to 6 participate. A research assistant will complete a detailed information
      session and written informed consent will be obtained prior enrolment.

      Lastly 20 community dwelling older adults will be invited to participate. Recruitment will
      occur through advertisement at a locally run seniors fitness group, conducted every Thursday
      at RBK. Older adults who are interested in being involved will be invited to receive
      additional information about the study and the involved procedures before providing written
      informed consent and being enrolled.

      All participation is entirely voluntary. Participants are free to withdraw at any time
      without stating a reason. Withdrawal or non-participation will not impact the care and
      services they are receiving or will receive from RBK now or in the future.

      The following inclusion criteria will be used: community-dwelling, aged between 60 and 80
      years and are able to walk 30m independently. Participants will be excluded if they report
      any severe cardiovascular, pulmonary, neurological, or mental diseases.

      In Trondheim researchers will recruit and include 20 healthy seniors, men and women, from
      senior exercise groups in local fitness centres and the municipality of Trondheim. They will
      approach leaders or instructors of the exercise groups and ask them to contact the
      participants in their exercise groups to ask whether they want to take part in this study.
      Those who are willing will be contacted by a research coordinator. Written informed consent
      will be obtained prior enrolment.

      Participants will be randomized to start with either the five times repeated instrumented
      Time up an Go Test (5iTUG) or clinical tests. The clinical tests include seven tests: the
      Community Balance and Mobility Scale (CBMS) (only the group of healthy participants), 8-level
      Balance Scale, 30s Chair stand (CS), Five times sit-to-stand (STS), Short Physical
      Performance Battery (SPPB), fast and habitual gait speed over 7 meters. Participants will
      complete the clinical tests according to the current standard clinical procedures. For the
      5iTUG, participants will be instructed to do the Time up and Go Test (TUG) five times with 30
      seconds rest between each repetition. The assessor will tell the participant when they should
      start walking. Participants will wear a smartphone attached with a belt to their lower back
      during the entire test sequence, both during the clinical tests and the 5iTUG. The assessor
      will demonstrate each test before the participants start. Participants can take breaks
      between tests or trials if needed. The assessor is experienced with testing of physical
      function in older adults, and will stand close to participants during all tasks especially
      where balance is challenged. At the end of the test-session, the assessor will administer one
      questionnaire about activities of daily living (ADL) function (the Late Life Function and
      Disability (LLFDI) questionnaire) and cognitive impairment based on screening via the
      Montreal Cognitive Assessment (MoCA).
observational model: Cohort
time perspective: Prospective
measure: five time repeated instrumented time up and Go Test (5iTUG)
time frame: Baseline
description: Discriminative ability of the 5iTUG compared to other clinical measurements (include acceleration, velocity, duration of movements, number of steps, and step variability, from the different sub-phases of the TUG test, such as sit-to-walk, walk, first/last turn, and walk-to-sit). By performing five repetitions of an instrumented TUG (5iTUG), it is possible to get features that are more sensitive from the instrument, in addition to in total five repetitions of sit-to-stand, turning, and turn-to-sit movements, along with a total of 30 meters of walking. The 5iTUG quantifies the movement characteristics from tasks that resembles those carried out in other independent clinical measurements and test batteries, such as the Five times sit-to-stand, gait assessments, and 30s chair stand. Variability repetitions within the trials will be analysed using a repeated measures analysis.
measure: five time Sit to Stand (5xSTS)
time frame: Baseline
description: needed time for 5 time repeated sit to stand
measure: 30 seconds Chair Stand (30s CS)
time frame: Baseline
description: 30 seconds chair stand number of repetitions
measure: Gait speed
time frame: Baseline
description: Gait speed measurement over 7 meters (habitual and fast gait speed), stopped with stopwatch
measure: Community Balance and Mobility Scale (CBMS)
time frame: Baseline
description: Community Balance and Mobility Scale, Score range from 0-96 points (with 96 is the best performance), duration: 35 minutes
measure: 8-level balance score
time frame: Baseline
description: 8-level balance score, each balance position held for 15 seconds, test stopped when position can not be completed, scored out of 8, higher points indicate better performance
measure: Short Physical Performance Battery (SPPB)
time frame: Baseline
description: Short Physical Performance Battery total and sub-scores, 3 balance tests each balance position held for 10 seconds, test stopped when position can not be completed, habitual gait speed over 4m, 5 time sit to stand, higher points indicate better performance, score range 0-12, duration: 8 minutes
measure: Late Life Function and Disability questionnaire for Function (LLFDI)
time frame: Baseline
description: Late Life Function and Disability (LLFDI) questionnaire, subjective measurement of functional ability and disability, scale range 0-100 points, higher points indicate better performance
arm group label: inpatient rehabilitation ward
description: The first 20 participants will be recruited from the inpatient rehabilitation ward at Robert-Bosch-Hospital (RBK). The treating medical doctor will inform potentially eligible participants about the possibility of being involved in this study. Should participants confirm their interest a research assistant will complete a detailed information session and obtain written informed consent prior enrolment.
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).
arm group label: outpatient rehabilitation clinic
description: Further 20 participants will be recruited through the outpatient rehabilitation clinic at Robert-Bosch-Hospital (RBK). The treating doctor will again inform the potential participant about the study and invite them to participate. A research assistant will complete a detailed information session and written informed consent will be obtained prior enrolment.
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).
arm group label: community dwelling older adults
description: Lastly 20 community dwelling older adults will be invited to participate. Recruitment will occur through advertisement at a locally run seniors fitness group, conducted every Thursday at RBK. Older adults who are interested in being involved will be invited to receive additional information about the study and the involved procedures before providing written informed consent and being enrolled.
Participants in the study don't receive any interventions, just a baseline measurement (only health outcomes are assessed).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Germany
citation: Studenski S, Perera S, Wallace D, Chandler JM, Duncan PW, Rooney E, Fox M, Guralnik JM. Physical performance measures in the clinical setting. J Am Geriatr Soc. 2003 Mar;51(3):314-22. doi: 10.1046/j.1532-5415.2003.51104.x.
PMID: 12588574
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PMID: 1991946
citation: Schoene D, Wu SM, Mikolaizak AS, Menant JC, Smith ST, Delbaere K, Lord SR. Discriminative ability and predictive validity of the timed up and go test in identifying older people who fall: systematic review and meta-analysis. J Am Geriatr Soc. 2013 Feb;61(2):202-8. doi: 10.1111/jgs.12106. Epub 2013 Jan 25.
PMID: 23350947
citation: Mellone S, Tacconi C, Chiari L. Validity of a Smartphone-based instrumented Timed Up and Go. Gait Posture. 2012 May;36(1):163-5. doi: 10.1016/j.gaitpost.2012.02.006. Epub 2012 Mar 14.
PMID: 22421189
responsible party type: Principal Investigator
investigator affiliation: Robert Bosch Gesellschaft für Medizinische Forschung mbH
investigator full name: Corinna Nerz
investigator title: Research associate/PhD Candidate
mesh term: Gait Disorders, Neurologic
sharing ipd: No