<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/NCT01723046</url>
  </required_header>
  <id_info>
    <org_study_id>IWT120278</org_study_id>
    <nct_id>NCT01723046</nct_id>
  </id_info>
  <brief_title>Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke</brief_title>
  <acronym>ARTHE</acronym>
  <official_title>Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas More Kempen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas More Kempen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to investigate the clinical effects of a new upper limb&#xD;
      robot assisted therapy device that is linked to a virtual therapy environment in patients&#xD;
      with stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of physically weak individuals is increasing, resulting in a higher burden on&#xD;
      health care and health care workers. The use of robot assisted therapy (RAT) might partly&#xD;
      solve this problem. Rehabilitation progress highly depends on training intensity and training&#xD;
      duration, favouring the use of RAT.&#xD;
&#xD;
      In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm&#xD;
      rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as&#xD;
      input for the device, assisting the user in flexion and extension of the elbow. The device is&#xD;
      coupled to a virtual environments, creating a stimulating therapy environment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer test upper limb section</measure>
    <time_frame>Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks</time_frame>
    <description>Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical research council score</measure>
    <time_frame>Change from baseline Medical research council score at 8 weeks and 12 weeks</time_frame>
    <description>Muscle strength assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Active range of motion of the elbow joint</measure>
    <time_frame>Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks</time_frame>
    <description>The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Passive range of motion of the elbow joint</measure>
    <time_frame>Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks</time_frame>
    <description>The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Ashworth Scale</measure>
    <time_frame>Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks</time_frame>
    <description>Spasticity measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ABILHAND questionnaire</measure>
    <time_frame>Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks</time_frame>
    <description>Questionnaire-based assessment of manual ability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional independence measure</measure>
    <time_frame>Change from baseline Functional independence measure score at 8 weeks and 12 weeks</time_frame>
    <description>Assessment of physical and cognitive disability, focusing on the burden of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke impact scale</measure>
    <time_frame>Change from baseline Stroke impact scale score at 8 weeks and 12 weeks</time_frame>
    <description>Questionnaire evaluating how stroke has impacted the person's health and life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intrinsic motivation inventory</measure>
    <time_frame>Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks</time_frame>
    <description>Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Training with the device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training with new upper limb robot assisted therapy device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group is treated with conventional therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Training with new upper limb robot assisted therapy device</intervention_name>
    <description>During 8 weeks, 3 times a week, 1 hour therapy sessions with the device</description>
    <arm_group_label>Training with the device</arm_group_label>
    <other_name>active orthosis</other_name>
    <other_name>exoskeleton</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with stroke, more than three months post onset&#xD;
&#xD;
          -  No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth&#xD;
             Scale)&#xD;
&#xD;
          -  Observable voluntary muscle activity in biceps and triceps muscle of the affected&#xD;
             upper limb (minimal score of 1 on the Medical research council score)&#xD;
&#xD;
          -  Able to sit on a chair with adequate trunk stability&#xD;
&#xD;
          -  Able to follow verbal instructions&#xD;
&#xD;
          -  Able to communicate verbal information to the researchers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are medically unstable&#xD;
&#xD;
          -  Cognitive disorders impeding the intervention&#xD;
&#xD;
          -  Visual disorders impeding the intervention&#xD;
&#xD;
          -  Subluxation of the shoulder joint&#xD;
&#xD;
          -  Pusher syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lore Van de Perre, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas More Kempen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lore Van de Perre, MSc</last_name>
    <phone>+32 14 56 23 10</phone>
    <email>lore.van.de.perre@khk.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thomas More Kempen</name>
      <address>
        <city>Geel</city>
        <state>Antwepen</state>
        <zip>2440</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Lore Van de Perre, MSc</last_name>
      <phone>+32 14 56 23 10</phone>
      <email>lore.van.de.perre@khk.be</email>
    </contact>
    <contact_backup>
      <last_name>Peter Karsmakers, PhD</last_name>
      <phone>+32 14 56 23 10</phone>
      <email>peter.karsmakers@khk.be</email>
    </contact_backup>
    <investigator>
      <last_name>Lore Van de Perre, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roy Sevit, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Koen Janssens, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Peter Karsmakers, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Louis Peeraer, Prof.PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>December 10, 2012</last_update_submitted>
  <last_update_submitted_qc>December 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thomas More Kempen</investigator_affiliation>
    <investigator_full_name>Lore Van de Perre</investigator_full_name>
    <investigator_title>Study principal investigator</investigator_title>
  </responsible_party>
  <keyword>Upper extremity</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Robot assisted therapy</keyword>
  <keyword>Robotics</keyword>
  <keyword>Devices</keyword>
  <keyword>Orthosis</keyword>
  <keyword>clinical outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01723046
org study id: IWT120278
nct id: NCT01723046
lead sponsor: 
has dmc: No
The purpose of this pilot study is to investigate the clinical effects of a new upper limb
      robot assisted therapy device that is linked to a virtual therapy environment in patients
      with stroke.
The number of physically weak individuals is increasing, resulting in a higher burden on
      health care and health care workers. The use of robot assisted therapy (RAT) might partly
      solve this problem. Rehabilitation progress highly depends on training intensity and training
      duration, favouring the use of RAT.

      In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm
      rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as
      input for the device, assisting the user in flexion and extension of the elbow. The device is
      coupled to a virtual environments, creating a stimulating therapy environment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer test upper limb section
time frame: Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks
description: Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery.
measure: Medical research council score
time frame: Change from baseline Medical research council score at 8 weeks and 12 weeks
description: Muscle strength assessment
measure: Active range of motion of the elbow joint
time frame: Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks
description: The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently
measure: Passive range of motion of the elbow joint
time frame: Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks
description: The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor.
measure: Modified Ashworth Scale
time frame: Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks
description: Spasticity measurement
measure: ABILHAND questionnaire
time frame: Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks
description: Questionnaire-based assessment of manual ability
measure: Functional independence measure
time frame: Change from baseline Functional independence measure score at 8 weeks and 12 weeks
description: Assessment of physical and cognitive disability, focusing on the burden of care.
measure: Stroke impact scale
time frame: Change from baseline Stroke impact scale score at 8 weeks and 12 weeks
description: Questionnaire evaluating how stroke has impacted the person's health and life.
measure: Intrinsic motivation inventory
time frame: Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks
description: Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments.
arm group label: Training with the device
arm group type: Experimental
description: Training with new upper limb robot assisted therapy device
arm group label: Control group
arm group type: No Intervention
description: The control group is treated with conventional therapy.
intervention type: Device
intervention name: Training with new upper limb robot assisted therapy device
description: During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
arm group label: Training with the device
other name: active orthosis
other name: exoskeleton
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Lore Van de Perre, MSc
role: Principal Investigator
affiliation: Thomas More Kempen
last name: Lore Van de Perre, MSc
phone: +32 14 56 23 10
email: lore.van.de.perre@khk.be
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Thomas More Kempen
investigator full name: Lore Van de Perre
investigator title: Study principal investigator
mesh term: Stroke