<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/NCT02257606</url>
  </required_header>
  <id_info>
    <org_study_id>CME2011/315</org_study_id>
    <nct_id>NCT02257606</nct_id>
  </id_info>
  <brief_title>Robot-assisted Training of the Upper Limb in Persons With Multiple Sclerosis: an Randomized Controlled Trial</brief_title>
  <official_title>Robot-assisted Training on the Upper Limb in Persons With MS: an RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Revalidatie &amp; MS Centrum Overpelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Expertise Centre for digital Media</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>tUL</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>iMinds</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Interreg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With this randomised intervention study, the investigators want to investigate the training&#xD;
      effect of an 8 week training regime, using a robot-assisted training system in persons with&#xD;
      MS. Besides conventional therapy, study participants in the experimental group will train 3&#xD;
      times per week during 30 minutes, using the haptic master. Research questions focus on the&#xD;
      effects of additional robot assisted training on range of motion, movement quality and&#xD;
      clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires&#xD;
      and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16&#xD;
      weeks of follow-&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">September 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motricity index</measure>
    <time_frame>2.5 min (pre-post)</time_frame>
    <description>Random motor activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer</measure>
    <time_frame>30 min (pre-post)</time_frame>
    <description>Assessment of recovery of motor function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Action Research arm test</measure>
    <time_frame>15-20 min (pre-post)</time_frame>
    <description>Grasp, grip, pinch, gross movement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor Activity log</measure>
    <time_frame>45 min (pre-post)</time_frame>
    <description>perceived activities of daily life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Jamar handgrip strength</measure>
    <time_frame>2.5 min (pre-post)</time_frame>
    <description>Handgrip strength</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Control group (persons with MS)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group (persons with MS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-assisted training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>I-TRAVLE training</intervention_name>
    <arm_group_label>Experimental group (persons with MS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with Multiple Sclerosis (McDonald criteria), upper limb dysfunction due to&#xD;
             muscle weakness (Motricity Index &lt;80), age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MS relapse or glucocorticosteroid treatment in the last month before the start of the&#xD;
             study, upper limb paralysis (Motricity Index &lt; 18), other sever limitations,&#xD;
             influencing participation (cognitive, visual)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>July 2, 2015</last_update_submitted>
  <last_update_submitted_qc>July 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2015</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>
  <!-- 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/NCT02257606
org study id: CME2011/315
nct id: NCT02257606
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
With this randomised intervention study, the investigators want to investigate the training
      effect of an 8 week training regime, using a robot-assisted training system in persons with
      MS. Besides conventional therapy, study participants in the experimental group will train 3
      times per week during 30 minutes, using the haptic master. Research questions focus on the
      effects of additional robot assisted training on range of motion, movement quality and
      clinical tests for the upper limb in persons with MS. Evaluation by means of questionnaires
      and clinical outcome measures occured at baseline, after 4 weeks, after 8 weeks and at 16
      weeks of follow-
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Motricity index
time frame: 2.5 min (pre-post)
description: Random motor activity
measure: Fugl-Meyer
time frame: 30 min (pre-post)
description: Assessment of recovery of motor function
measure: Action Research arm test
time frame: 15-20 min (pre-post)
description: Grasp, grip, pinch, gross movement
measure: Motor Activity log
time frame: 45 min (pre-post)
description: perceived activities of daily life
measure: Jamar handgrip strength
time frame: 2.5 min (pre-post)
description: Handgrip strength
arm group label: Control group (persons with MS)
arm group type: No Intervention
description: no training
arm group label: Experimental group (persons with MS)
arm group type: Experimental
description: Robot-assisted training
intervention type: Other
intervention name: I-TRAVLE training
arm group label: Experimental group (persons with MS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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