<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/NCT04441190</url>
  </required_header>
  <id_info>
    <org_study_id>201901885A3</org_study_id>
    <nct_id>NCT04441190</nct_id>
  </id_info>
  <brief_title>Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy</brief_title>
  <official_title>A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      The specific study aims will be:&#xD;
&#xD;
        1. To develop the novel, digital, and interactive MSR system of arm and hand with&#xD;
           integrated digital action observation therapy (AOT) and mirror therapy (MT).&#xD;
&#xD;
        2. To pilot usability testing for examining the feasibility of this new MSR system from the&#xD;
           users' experiences and feedback.&#xD;
&#xD;
        3. To examine the treatment effects of digital AOT, digital MT and a control intervention&#xD;
           in patients with stroke by conducting a randomized controlled trial.&#xD;
&#xD;
        4. To identify who will be the possible good responders to digital AOT and MT based on&#xD;
           their baseline motor function and mental imagery abilities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I: Multi-mode stroke rehabilitation (MSR) System Development &amp; Usability Testing&#xD;
&#xD;
      Ten patients with stroke and 4 certified occupational therapists were recruited in this phase&#xD;
      I study. During the pilot testing, each stroke patient will try to use each training mode of&#xD;
      digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the&#xD;
      patients and the therapists will be asked to complete the System Usability Scale and a&#xD;
      self-designed questionnaire to assess the user experience and perspective about this new MSR&#xD;
      system and their view of its suitability for stroke patients.&#xD;
&#xD;
      Phase II: Validation of Clinical Treatment Efficacy&#xD;
&#xD;
      This three-arm, single-blind, randomized controlled trial will investigate the treatment&#xD;
      effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention.&#xD;
      An estimated 60 patients with stroke will be recruited to participate in this phase II study.&#xD;
      Each participant will receive a total of 15 training sessions (60 minutes per session) for 3&#xD;
      to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after&#xD;
      treatment (the fourth week), and at 1 month follow-up after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 11, 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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change scores of Fugl-Meyer Assessment</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change scores of Movement Imagery Questionnaire-Revised, Second Edition</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change scores of Chedoke Arm and Hand Activity Inventory</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Box and Block Test</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Revised Nottingham Sensory Assessment</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Barthel Index</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of Motor Activity Log</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of the health state of EQ-5D-5L</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change scores of the visual analogue scale (VAS) of EQ-5D-5L</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of joint angles of OPAL wearable sensors</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of joint velocity of OPAL wearable sensors</measure>
    <time_frame>baseline, 4 weeks, 2 months</time_frame>
    <description>The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Stroke</condition>
  <condition>Cerebrovascular Disorders</condition>
  <condition>Central Nervous System Diseases</condition>
  <arm_group>
    <arm_group_label>Digital Action Observation Therapy (Digital AOT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Digital Mirror Therapy (Digital MT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Occupational Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Action Observation Therapy (Digital AOT)</intervention_name>
    <description>The participants will be asked to observe videos and then practice what the participants observed.</description>
    <arm_group_label>Digital Action Observation Therapy (Digital AOT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Mirror Therapy (Digital MT)</intervention_name>
    <description>The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.</description>
    <arm_group_label>Digital Mirror Therapy (Digital MT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Occupational Therapy</intervention_name>
    <description>The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.</description>
    <arm_group_label>Conventional Occupational Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing&#xD;
&#xD;
        For stroke patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as having a unilateral stroke;&#xD;
&#xD;
          -  aged from 20 to 80 years;&#xD;
&#xD;
          -  a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;&#xD;
&#xD;
          -  able to follow the instructions and able to provide user feedback verbally;&#xD;
&#xD;
          -  without aphasia and neglect&#xD;
&#xD;
        For therapists&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  holding an occupational therapist license&#xD;
&#xD;
        Phase II: Validation of Clinical Treatment Efficacy&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed as having a unilateral stroke;&#xD;
&#xD;
          -  at least 6 months after stroke onset;&#xD;
&#xD;
          -  aged from 20 to 80 years;&#xD;
&#xD;
          -  a baseline score of FMA in a range of 20 to 60;&#xD;
&#xD;
          -  able to follow the study instructions;&#xD;
&#xD;
          -  capable of participating in therapy and assessment sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  global or receptive aphasia,&#xD;
&#xD;
          -  severe neglect,&#xD;
&#xD;
          -  major medical problems or comorbidities that have influenced upper-limb usage or&#xD;
             caused severe pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Wei Hsieh, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Occupational Therapy, College of Medicine, Chang Gung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taipei Hospital, Ministry of Health and Welfare</name>
      <address>
        <city>New Taipei City</city>
        <zip>24213</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taoyuan Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 23, 2021</last_update_submitted>
  <last_update_submitted_qc>November 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>multi-mode rehabilitation</keyword>
  <keyword>action observation</keyword>
  <keyword>mirror therapy</keyword>
  <keyword>digital image technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Cerebrovascular Disorders</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/NCT04441190
org study id: 201901885A3
nct id: NCT04441190
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The specific study aims will be:

        1. To develop the novel, digital, and interactive MSR system of arm and hand with
           integrated digital action observation therapy (AOT) and mirror therapy (MT).

        2. To pilot usability testing for examining the feasibility of this new MSR system from the
           users' experiences and feedback.

        3. To examine the treatment effects of digital AOT, digital MT and a control intervention
           in patients with stroke by conducting a randomized controlled trial.

        4. To identify who will be the possible good responders to digital AOT and MT based on
           their baseline motor function and mental imagery abilities.
Phase I: Multi-mode stroke rehabilitation (MSR) System Development & Usability Testing

      Ten patients with stroke and 4 certified occupational therapists were recruited in this phase
      I study. During the pilot testing, each stroke patient will try to use each training mode of
      digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the
      patients and the therapists will be asked to complete the System Usability Scale and a
      self-designed questionnaire to assess the user experience and perspective about this new MSR
      system and their view of its suitability for stroke patients.

      Phase II: Validation of Clinical Treatment Efficacy

      This three-arm, single-blind, randomized controlled trial will investigate the treatment
      effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention.
      An estimated 60 patients with stroke will be recruited to participate in this phase II study.
      Each participant will receive a total of 15 training sessions (60 minutes per session) for 3
      to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after
      treatment (the fourth week), and at 1 month follow-up after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change scores of Fugl-Meyer Assessment
time frame: baseline, 4 weeks, 2 months
description: The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
measure: Change scores of Movement Imagery Questionnaire-Revised, Second Edition
time frame: baseline, 4 weeks, 2 months
description: The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
measure: Change scores of Chedoke Arm and Hand Activity Inventory
time frame: baseline, 4 weeks, 2 months
description: The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
measure: Change scores of Box and Block Test
time frame: baseline, 4 weeks, 2 months
description: The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
measure: Change scores of Revised Nottingham Sensory Assessment
time frame: baseline, 4 weeks, 2 months
description: The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
measure: Change scores of Barthel Index
time frame: baseline, 4 weeks, 2 months
description: The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
measure: Change scores of Motor Activity Log
time frame: baseline, 4 weeks, 2 months
description: The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.
measure: Change scores of the health state of EQ-5D-5L
time frame: baseline, 4 weeks, 2 months
description: The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.
measure: Change scores of the visual analogue scale (VAS) of EQ-5D-5L
time frame: baseline, 4 weeks, 2 months
description: The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
measure: Change of joint angles of OPAL wearable sensors
time frame: baseline, 4 weeks, 2 months
description: The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.
measure: Change of joint velocity of OPAL wearable sensors
time frame: baseline, 4 weeks, 2 months
description: The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.
arm group label: Digital Action Observation Therapy (Digital AOT)
arm group type: Experimental
description: The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
arm group label: Digital Mirror Therapy (Digital MT)
arm group type: Experimental
description: The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
arm group label: Conventional Occupational Therapy
arm group type: Active Comparator
description: The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
intervention type: Behavioral
intervention name: Digital Action Observation Therapy (Digital AOT)
description: The participants will be asked to observe videos and then practice what the participants observed.
arm group label: Digital Action Observation Therapy (Digital AOT)
intervention type: Behavioral
intervention name: Digital Mirror Therapy (Digital MT)
description: The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
arm group label: Digital Mirror Therapy (Digital MT)
intervention type: Behavioral
intervention name: Conventional Occupational Therapy
description: The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
arm group label: Conventional Occupational Therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu-Wei Hsieh, PhD
role: Principal Investigator
affiliation: Department of Occupational Therapy, College of Medicine, Chang Gung University
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
mesh term: Cerebrovascular Disorders
sharing ipd: No