<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/NCT03294187</url>
  </required_header>
  <id_info>
    <org_study_id>2017-00948</org_study_id>
    <nct_id>NCT03294187</nct_id>
  </id_info>
  <brief_title>Encouragement-induced Movement Therapy in Daily Life</brief_title>
  <acronym>ISEAR</acronym>
  <official_title>Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tyromotion AG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swiss Federal Institute of Technology in Zurich (ETH Zurich)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</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>
      Stroke places a major burden on health care and society. It often leads to a hemiparesis.&#xD;
      Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or&#xD;
      human resources to provide this intensive rehabilitation are often lacking. Applying&#xD;
      modern-day tracking and feedback technology to encourage a self-administered, context&#xD;
      specific training is expected to offer significant potential to increase intensity of&#xD;
      practice. Up until now, there has been no randomized trial examining the effect of such an&#xD;
      intervention on daily arm usage.&#xD;
&#xD;
      The primary objective of this study is to determine the effect of wearing an activity&#xD;
      tracking and multimodal feedback device for six weeks on self-reported daily life use of the&#xD;
      paretic arm after stroke, when compared to control group stroke subjects wearing a&#xD;
      hardware-wise identical sham device providing no feedback. The secondary aim is to examine&#xD;
      compliance to use the device and the quantitative, qualitative and functional improvement of&#xD;
      the paretic arm. It is hypothesized that participants in the experimental group show a higher&#xD;
      change in self-reported daily life use of the paretic arm when compared to the control group&#xD;
      both post intervention and at 6-week follow-up.&#xD;
&#xD;
      ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond&#xD;
      the first 3 months poststroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">November 25, 2021</completion_date>
  <primary_completion_date type="Actual">November 25, 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor Activity Log - 14, Amount of Use sub scale</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Self-reported amount of upper limb use in daily life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment, Upper Extremity sub scale</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Upper limb motor function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment, Upper Extremity sub scale</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Upper limb motor function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Upper limb capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Research Arm Test</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Upper limb capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Global Disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Global Disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol five dimensions five levels questionnaire</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol five dimensions five levels questionnaire</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Quality of Life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log - 14, Quality of Movement sub scale</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Self-reported quality of upper limb use in daily life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log - 14, Quality of Movement sub scale</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Self-reported quality of upper limb use in daily life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Activity Log - 14, Amount of Use sub scale</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Self-reported amount of upper limb use in daily life</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Global Rating of Perceived Change</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Global Rating of Perceived Change</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Concomitant movement therapy</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)</description>
  </other_outcome>
  <other_outcome>
    <measure>Concomitant movement therapy</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Baseline (0 week)</time_frame>
    <description>Safety</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Post-intervention (6 weeks)</time_frame>
    <description>Safety</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Follow-up (12 weeks)</time_frame>
    <description>Safety</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Monitoring and Feedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monitoring</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wrist-worn wearables</intervention_name>
    <description>See arm/group description.</description>
    <arm_group_label>Monitoring</arm_group_label>
    <arm_group_label>Monitoring and Feedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 18 years of age with unilateral stroke and residual hemiparesis leading to a&#xD;
             decrease of arm function after completion of all inpatient rehabilitation (at least 90&#xD;
             days post stroke)&#xD;
&#xD;
          -  Ability to lift arm against gravity (&gt;30 degrees flexion or abduction)&#xD;
&#xD;
          -  Ability to don/doff the devices on both wrists independently or with assistance of a&#xD;
             caregiver&#xD;
&#xD;
          -  Ability to give informed consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major untreated depression&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
&#xD;
          -  Suffering from comprehensive aphasia&#xD;
&#xD;
          -  Severely impaired sensation (unable to feel a soft touch on the dorsal side of their&#xD;
             paretic wrist with closed eyes)&#xD;
&#xD;
          -  Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic&#xD;
             dysfunction, orthopedic disorders, etc.)&#xD;
&#xD;
          -  Expected hospitalization during study period&#xD;
&#xD;
          -  Known intolerance to device material&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  The investigator, his/her family members, employees, and other dependent persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andreas R Luft, Prof. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cereneo, Center For Neurology and Rehabilitation</name>
      <address>
        <city>Vitznau</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zürcher RehaZentrum Wald</name>
      <address>
        <city>Wald</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 12, 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>November 25, 2021</last_update_submitted>
  <last_update_submitted_qc>November 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Upper Extremity</keyword>
  <keyword>Feedback</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03294187
org study id: 2017-00948
nct id: NCT03294187
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stroke places a major burden on health care and society. It often leads to a hemiparesis.
      Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or
      human resources to provide this intensive rehabilitation are often lacking. Applying
      modern-day tracking and feedback technology to encourage a self-administered, context
      specific training is expected to offer significant potential to increase intensity of
      practice. Up until now, there has been no randomized trial examining the effect of such an
      intervention on daily arm usage.

      The primary objective of this study is to determine the effect of wearing an activity
      tracking and multimodal feedback device for six weeks on self-reported daily life use of the
      paretic arm after stroke, when compared to control group stroke subjects wearing a
      hardware-wise identical sham device providing no feedback. The secondary aim is to examine
      compliance to use the device and the quantitative, qualitative and functional improvement of
      the paretic arm. It is hypothesized that participants in the experimental group show a higher
      change in self-reported daily life use of the paretic arm when compared to the control group
      both post intervention and at 6-week follow-up.

      ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond
      the first 3 months poststroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Motor Activity Log - 14, Amount of Use sub scale
time frame: Post-intervention (6 weeks)
description: Self-reported amount of upper limb use in daily life
measure: Fugl-Meyer Assessment, Upper Extremity sub scale
time frame: Post-intervention (6 weeks)
description: Upper limb motor function
measure: Fugl-Meyer Assessment, Upper Extremity sub scale
time frame: Follow-up (12 weeks)
description: Upper limb motor function
measure: Action Research Arm Test
time frame: Post-intervention (6 weeks)
description: Upper limb capacity
measure: Action Research Arm Test
time frame: Follow-up (12 weeks)
description: Upper limb capacity
measure: Modified Rankin Scale
time frame: Post-intervention (6 weeks)
description: Global Disability
measure: Modified Rankin Scale
time frame: Follow-up (12 weeks)
description: Global Disability
measure: EuroQol five dimensions five levels questionnaire
time frame: Post-intervention (6 weeks)
description: Quality of Life
measure: EuroQol five dimensions five levels questionnaire
time frame: Follow-up (12 weeks)
description: Quality of Life
measure: Motor Activity Log - 14, Quality of Movement sub scale
time frame: Post-intervention (6 weeks)
description: Self-reported quality of upper limb use in daily life
measure: Motor Activity Log - 14, Quality of Movement sub scale
time frame: Follow-up (12 weeks)
description: Self-reported quality of upper limb use in daily life
measure: Motor Activity Log - 14, Amount of Use sub scale
time frame: Follow-up (12 weeks)
description: Self-reported amount of upper limb use in daily life
measure: Global Rating of Perceived Change
time frame: Post-intervention (6 weeks)
measure: Global Rating of Perceived Change
time frame: Follow-up (12 weeks)
measure: Concomitant movement therapy
time frame: Post-intervention (6 weeks)
description: Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)
measure: Concomitant movement therapy
time frame: Follow-up (12 weeks)
measure: Adverse Events
time frame: Baseline (0 week)
description: Safety
measure: Adverse Events
time frame: Post-intervention (6 weeks)
description: Safety
measure: Adverse Events
time frame: Follow-up (12 weeks)
description: Safety
arm group label: Monitoring and Feedback
arm group type: Experimental
description: Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
arm group label: Monitoring
arm group type: Placebo Comparator
description: Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.
intervention type: Device
intervention name: Wrist-worn wearables
description: See arm/group description.
arm group label: Monitoring
arm group label: Monitoring and Feedback
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas R Luft, Prof. MD
role: Principal Investigator
affiliation: University of Zurich
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No