<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/NCT04463888</url>
  </required_header>
  <id_info>
    <org_study_id>B-BR-107-084</org_study_id>
    <nct_id>NCT04463888</nct_id>
  </id_info>
  <brief_title>A Smart Home-based Exoskeleton Robot System for Stroke Patients</brief_title>
  <official_title>Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      In the proposed study, the investigators assumed that high dose of repetitive motor task&#xD;
      training using an exoskeleton robot-assisted system may provide benefits in motor shaping and&#xD;
      greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of&#xD;
      therapeutic activity with clinicians' guidance is often short of number in therapy&#xD;
      sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the&#xD;
      data they generate that are a new trend of rehabilitation strategy for providing remote&#xD;
      home-programs support. The specific aim of this study is to to explore the feasibility of&#xD;
      introducing the rental services of a Smart Home-based Exoskeleton Robot System through the&#xD;
      IoT business model. And the second purpose is to investigate the effects of applying the&#xD;
      exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic&#xD;
      stroke patients.The expected outcomes of this research are to clarify the feasibility of&#xD;
      using IoT business model for launching smart rehabilitation device rental service and the&#xD;
      effects of application a high dosage of hand movement training as home program on motor and&#xD;
      hand function for patients with chronic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2020</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the result of Box and blocks test</measure>
    <time_frame>baseline, 4 weeks, 16 weeks and 20 weeks</time_frame>
    <description>The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the result of Fugl-Meyer assessment for UE motor function</measure>
    <time_frame>baseline, 4 weeks, 16 weeks and 20 weeks</time_frame>
    <description>Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the result of Modified Ashworth scale (MAS)</measure>
    <time_frame>baseline, 4 weeks,16 weeks and 20 weeks</time_frame>
    <description>Muscle tone is defined by the resistance of a muscle being stretched without resistance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the result of Semmes-Weinstein monofilament (SWM) test</measure>
    <time_frame>baseline, 4 weeks,16 weeks and 20 weeks</time_frame>
    <description>The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the result of Motor Activity Log</measure>
    <time_frame>baseline, 4 weeks,16 weeks and 20 weeks</time_frame>
    <description>MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical global impression scale</measure>
    <time_frame>post-intervention (week 4)</time_frame>
    <description>Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Rehabilitation, Tenodesis, Stroke, Internet of Things</condition>
  <arm_group>
    <arm_group_label>Robot training with Smart Home-based Exoskeleton Robot System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>occupational therapy</intervention_name>
    <description>occupational therapy targeted to goals that are relevant to the functional needs of the patient</description>
    <arm_group_label>Robot training with Smart Home-based Exoskeleton Robot System</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2)&#xD;
             computed tomography scan that excluded pathologies other than unilateral cerebral&#xD;
             hemisphere injury, (3) capacity to perform a pinch task with the thumb and index&#xD;
             finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory,&#xD;
             perceptual, praxis, and memory, as determined using Lowenstein occupational therapy&#xD;
             cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading&#xD;
             to difficulty of following instruction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng-Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04463888
org study id: B-BR-107-084
nct id: NCT04463888
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the proposed study, the investigators assumed that high dose of repetitive motor task
      training using an exoskeleton robot-assisted system may provide benefits in motor shaping and
      greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of
      therapeutic activity with clinicians' guidance is often short of number in therapy
      sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the
      data they generate that are a new trend of rehabilitation strategy for providing remote
      home-programs support. The specific aim of this study is to to explore the feasibility of
      introducing the rental services of a Smart Home-based Exoskeleton Robot System through the
      IoT business model. And the second purpose is to investigate the effects of applying the
      exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic
      stroke patients.The expected outcomes of this research are to clarify the feasibility of
      using IoT business model for launching smart rehabilitation device rental service and the
      effects of application a high dosage of hand movement training as home program on motor and
      hand function for patients with chronic stroke.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the result of Box and blocks test
time frame: baseline, 4 weeks, 16 weeks and 20 weeks
description: The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
measure: Change in the result of Fugl-Meyer assessment for UE motor function
time frame: baseline, 4 weeks, 16 weeks and 20 weeks
description: Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
measure: Change in the result of Modified Ashworth scale (MAS)
time frame: baseline, 4 weeks,16 weeks and 20 weeks
description: Muscle tone is defined by the resistance of a muscle being stretched without resistance.
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
time frame: baseline, 4 weeks,16 weeks and 20 weeks
description: The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
measure: Change in the result of Motor Activity Log
time frame: baseline, 4 weeks,16 weeks and 20 weeks
description: MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale.
measure: Clinical global impression scale
time frame: post-intervention (week 4)
description: Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system.
arm group label: Robot training with Smart Home-based Exoskeleton Robot System
arm group type: Experimental
description: In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks .
arm group label: control group
arm group type: Active Comparator
description: In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks .
intervention type: Other
intervention name: occupational therapy
description: occupational therapy targeted to goals that are relevant to the functional needs of the patient
arm group label: Robot training with Smart Home-based Exoskeleton Robot System
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke