<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/NCT03281330</url>
  </required_header>
  <id_info>
    <org_study_id>B67021629797</org_study_id>
    <nct_id>NCT03281330</nct_id>
  </id_info>
  <brief_title>Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)</brief_title>
  <official_title>Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Revalidatie &amp; MS Centrum Overpelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National MS Center Melsbroek</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</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 study investigates the effect of different conditions of auditory cueing and music on&#xD;
      walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy&#xD;
      controls. The study extends over a four session period, each session lasting maximally 1h30&#xD;
      minutes The experimental conditions include participants walking to music and metronome (at&#xD;
      different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes&#xD;
      in between each condition. Non-invasive equipment will be used. participants are equipped&#xD;
      with sensors (watch-like straps at the wrists, ankles and across the chest) and are given&#xD;
      wireless headphones.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>Spatio-temporal parameters of gait</measure>
    <time_frame>day 1</time_frame>
    <description>Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatio-temporal parameters of gait</measure>
    <time_frame>week 1</time_frame>
    <description>Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatio-temporal parameters of gait</measure>
    <time_frame>week 2</time_frame>
    <description>Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatio-temporal parameters of gait</measure>
    <time_frame>week 3</time_frame>
    <description>Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parameter's of sychronisation</measure>
    <time_frame>day 1</time_frame>
    <description>Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parameter's of sychronisation</measure>
    <time_frame>week 1</time_frame>
    <description>Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parameter's of sychronisation</measure>
    <time_frame>week 2</time_frame>
    <description>Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parameter's of sychronisation</measure>
    <time_frame>week 3</time_frame>
    <description>Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>subjective physical /mental fatigue</measure>
    <time_frame>day 1</time_frame>
    <description>After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective physical /mental fatigue</measure>
    <time_frame>week 1</time_frame>
    <description>After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subjective physical /mental fatigue</measure>
    <time_frame>week 2</time_frame>
    <description>After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical /mental fatigue</measure>
    <time_frame>week 3</time_frame>
    <description>After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation</measure>
    <time_frame>day 1</time_frame>
    <description>he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation</measure>
    <time_frame>week 1</time_frame>
    <description>he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation</measure>
    <time_frame>week 2</time_frame>
    <description>he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>motivation</measure>
    <time_frame>week 3</time_frame>
    <description>he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>persons with Multiple Sclerosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>auditory cues and music during walking</intervention_name>
    <description>the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls</description>
    <arm_group_label>Healthy controls</arm_group_label>
    <arm_group_label>persons with Multiple Sclerosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        persons with Multiple Sclerosis and healthy volonteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of MS of &gt;1 year,&#xD;
&#xD;
          -  no relapse in the last 1 month,&#xD;
&#xD;
          -  ability to walk for 12 minutes without interruption,&#xD;
&#xD;
          -  an average usual walking speed between the range of 0.4 and 1.2 m/s.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment hindering the understanding and execution of the experimental&#xD;
             procedures&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  hearing impairment&#xD;
&#xD;
          -  amusia&#xD;
&#xD;
          -  beat deafness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Ghent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationaal Multiple Sclerose Center</name>
      <address>
        <city>Melsbroek</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revalidatie &amp; MS Centrum Overpelt</name>
      <address>
        <city>Overpelt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>August 2, 2018</last_update_submitted>
  <last_update_submitted_qc>August 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Peter Feys</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03281330
org study id: B67021629797
nct id: NCT03281330
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the effect of different conditions of auditory cueing and music on
      walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy
      controls. The study extends over a four session period, each session lasting maximally 1h30
      minutes The experimental conditions include participants walking to music and metronome (at
      different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes
      in between each condition. Non-invasive equipment will be used. participants are equipped
      with sensors (watch-like straps at the wrists, ankles and across the chest) and are given
      wireless headphones.
observational model: Cohort
time perspective: Prospective
measure: Spatio-temporal parameters of gait
time frame: day 1
description: Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
measure: Spatio-temporal parameters of gait
time frame: week 1
description: Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
measure: Spatio-temporal parameters of gait
time frame: week 2
description: Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
measure: Spatio-temporal parameters of gait
time frame: week 3
description: Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.
measure: Parameter's of sychronisation
time frame: day 1
description: Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters
measure: Parameter's of sychronisation
time frame: week 1
description: Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters
measure: Parameter's of sychronisation
time frame: week 2
description: Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters
measure: Parameter's of sychronisation
time frame: week 3
description: Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters
measure: subjective physical /mental fatigue
time frame: day 1
description: After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'
measure: subjective physical /mental fatigue
time frame: week 1
description: After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'
measure: subjective physical /mental fatigue
time frame: week 2
description: After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'
measure: physical /mental fatigue
time frame: week 3
description: After each experimental condition, the participant is asked 'how tired do you feel in your body on a scale of 0 to 10, 0 being not tired at all and 10 being exhausted'
measure: motivation
time frame: day 1
description: he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.
measure: motivation
time frame: week 1
description: he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.
measure: motivation
time frame: week 2
description: he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.
measure: motivation
time frame: week 3
description: he participants is asked: 'how motivating was it to walk to the last particular stimuli (in the metronome condition)/Song (in the music condition) on a scale of 0-5. ) being not motivating at all and 5 being very motivating'.
arm group label: persons with Multiple Sclerosis
arm group label: Healthy controls
intervention type: Behavioral
intervention name: auditory cues and music during walking
description: the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls
arm group label: Healthy controls
arm group label: persons with Multiple Sclerosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Peter Feys
investigator title: prof. dr.
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided