<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/NCT04502264</url>
  </required_header>
  <id_info>
    <org_study_id>(745)108A-61</org_study_id>
    <nct_id>NCT04502264</nct_id>
  </id_info>
  <brief_title>Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections</brief_title>
  <official_title>Effects of EMG-driven Robot-assisted Therapy for the Distal Upper Limb Motor Function in the Chronic Stroke Patients With Botox Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cheng-Hsin General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cheng-Hsin General 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>
      Over fifty percent of stroke patients experience chronic arm hand performance problems,&#xD;
      compromising independence in daily life activities and quality of life. Traditionally, the&#xD;
      effectiveness of rehabilitation in improving functioning for stroke patients more than 6&#xD;
      months has not been proven. However, spontaneous neurological recovery reaches the plateau at&#xD;
      3~6 months later.&#xD;
&#xD;
      Hand of Hope is a virtual reality (VR)-based, electromyography (EMG)-driven, and&#xD;
      task-oriented hand robot. Otherwise, it needs patients to have active participation during&#xD;
      the intervention which is critical for motor recovery after stroke. Robotic rehabilitation&#xD;
      devices have the potential to deliver high-intensity, reproducible therapy. Robot-assisted&#xD;
      task-oriented training had been proposed by several researchers, but the evidence of clinical&#xD;
      effectiveness in highly functional chronic stroke patients is still lack.&#xD;
&#xD;
      Spasticity is a common disorder which occurs following stroke. The prevalence of post-stroke&#xD;
      spasticity can be as high as 46% in the chronic phase (over 3 months). Spasticity impacted&#xD;
      activities of daily living, quality of life, pain, and functional impairments. Long-term&#xD;
      spasticity may lead to tendon contracture and limb deformities. Botulinum toxin injection,&#xD;
      which mostly used in chronic phase (over 6 months), had been proved to be a safe agent&#xD;
      representing the gold standard treatment for focal spasticity, while avoiding systemic&#xD;
      effects. But the effects of botulism toxin on functional ability are still unclear. Moreover,&#xD;
      there is insufficient evidence on adjunctive therapies following botulism toxin.&#xD;
&#xD;
      The purpose of the present study is to examine the effects of botulinum toxin injection&#xD;
      combined with Hand of Hope and standard occupational therapy on upper extremity function, and&#xD;
      compares the findings to those of amount-matched chronic stroke survivors who received only&#xD;
      Botulinum toxin injection and standard occupational therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 9, 2020</start_date>
  <completion_date type="Anticipated">December 9, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 9, 2023</primary_completion_date>
  <phase>Phase 2</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>modified Ashworth scale</measure>
    <time_frame>14 weeks</time_frame>
    <description>Modified Ashworth scale is a scale for spasticity evaluation, while 0 means no spasticity, 1 means slight increase in muscle tone, 1+ means more muscle tone than score equels 1, 2 means more marked muscle tone, 3 means passive movement is difficult, and 4 means rigidity. We would record modified Ashworth scale at upper limb of the hemiplegic patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>H-reflex</measure>
    <time_frame>14 weeks</time_frame>
    <description>H-reflex is a method of electricophysilogic evaluation for spasticity in nerve conduction study, while decreased latency means stronger muscle tone and prolonged latency means weaker muscle tone. H-reflex of all limbs at these patients would be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Box &amp; Block Test</measure>
    <time_frame>14 weeks</time_frame>
    <description>The Box and Block Test (BBT) measures unilateral gross manual dexterity. 150 blocks is set up at the test box, and clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores are indicative of better manual dexterity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nine Hole Peg Test</measure>
    <time_frame>14 weeks</time_frame>
    <description>The Nine-Hole Peg Test is used to measure finger dexterity by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version</measure>
    <time_frame>14 weeks</time_frame>
    <description>The World Health Organization Quality of Life (WHOQOL-BREF) is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items); with another 2 items about general condition and overall quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The higher scores equals better quality of life.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Stroke</condition>
  <condition>Spasticity as Sequela of Stroke</condition>
  <condition>Robotic Rehabilitation</condition>
  <arm_group>
    <arm_group_label>Botulinum toxin, hand robot training, occupational therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient would receive Botulinum toxin (Injections of 100~400U of Botox in the upper limb muscle with a 2ml/100U dilution), robot-assisted therapy (Hand of Hope training), and standard occupational therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum toxin, occupational therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient would receive Botulinum toxin (Injections of 100~400U of Botox in the upper limb muscle with a 2ml/100U dilution) and standard occupational therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hand of Hope</intervention_name>
    <description>A virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot.</description>
    <arm_group_label>Botulinum toxin, hand robot training, occupational therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum toxin type A injection</intervention_name>
    <description>A safe agent representing the gold standard treatment for focal spasticity.</description>
    <arm_group_label>Botulinum toxin, hand robot training, occupational therapy</arm_group_label>
    <arm_group_label>Botulinum toxin, occupational therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 20-85 year-old&#xD;
&#xD;
          -  The onset of stroke must be at least 6 month previously&#xD;
&#xD;
          -  The stroke must be the first event&#xD;
&#xD;
          -  The stroke must be unilateral brain lesion&#xD;
&#xD;
          -  Spasticity measured as Modified Ashworth scale during 1+ to 3&#xD;
&#xD;
          -  Score at least 1 point in the wrist subtest of Fugl-Meyer Assessment&#xD;
&#xD;
          -  Brunnstrom stage of proximal upper limb at least 3, distal upper limb between 2 to 5&#xD;
&#xD;
          -  No impairment in visual tracking ability&#xD;
&#xD;
          -  No impairment in proprioception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe joints pain of hand or finger at affected limb&#xD;
&#xD;
          -  Fracture of affected limb in three months&#xD;
&#xD;
          -  Brunnstrom stage of proximal upper limb not more than 2, distal upper limb more than 5&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Szu-Fu Chen</last_name>
    <phone>+886-2-28264400</phone>
    <phone_ext>3806</phone_ext>
    <email>szufuchen@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cheng-Hsin general hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Szu-Fu Chen</last_name>
      <phone>+886-2-28264400</phone>
      <phone_ext>3806</phone_ext>
      <email>szufuchen@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>February 10, 2023</last_update_submitted>
  <last_update_submitted_qc>February 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hand of hope</keyword>
  <keyword>hand robot</keyword>
  <keyword>Botulinum toxin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04502264
org study id: (745)108A-61
nct id: NCT04502264
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Over fifty percent of stroke patients experience chronic arm hand performance problems,
      compromising independence in daily life activities and quality of life. Traditionally, the
      effectiveness of rehabilitation in improving functioning for stroke patients more than 6
      months has not been proven. However, spontaneous neurological recovery reaches the plateau at
      3~6 months later.

      Hand of Hope is a virtual reality (VR)-based, electromyography (EMG)-driven, and
      task-oriented hand robot. Otherwise, it needs patients to have active participation during
      the intervention which is critical for motor recovery after stroke. Robotic rehabilitation
      devices have the potential to deliver high-intensity, reproducible therapy. Robot-assisted
      task-oriented training had been proposed by several researchers, but the evidence of clinical
      effectiveness in highly functional chronic stroke patients is still lack.

      Spasticity is a common disorder which occurs following stroke. The prevalence of post-stroke
      spasticity can be as high as 46% in the chronic phase (over 3 months). Spasticity impacted
      activities of daily living, quality of life, pain, and functional impairments. Long-term
      spasticity may lead to tendon contracture and limb deformities. Botulinum toxin injection,
      which mostly used in chronic phase (over 6 months), had been proved to be a safe agent
      representing the gold standard treatment for focal spasticity, while avoiding systemic
      effects. But the effects of botulism toxin on functional ability are still unclear. Moreover,
      there is insufficient evidence on adjunctive therapies following botulism toxin.

      The purpose of the present study is to examine the effects of botulinum toxin injection
      combined with Hand of Hope and standard occupational therapy on upper extremity function, and
      compares the findings to those of amount-matched chronic stroke survivors who received only
      Botulinum toxin injection and standard occupational therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: modified Ashworth scale
time frame: 14 weeks
description: Modified Ashworth scale is a scale for spasticity evaluation, while 0 means no spasticity, 1 means slight increase in muscle tone, 1+ means more muscle tone than score equels 1, 2 means more marked muscle tone, 3 means passive movement is difficult, and 4 means rigidity. We would record modified Ashworth scale at upper limb of the hemiplegic patients.
measure: H-reflex
time frame: 14 weeks
description: H-reflex is a method of electricophysilogic evaluation for spasticity in nerve conduction study, while decreased latency means stronger muscle tone and prolonged latency means weaker muscle tone. H-reflex of all limbs at these patients would be recorded.
measure: Box & Block Test
time frame: 14 weeks
description: The Box and Block Test (BBT) measures unilateral gross manual dexterity. 150 blocks is set up at the test box, and clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores are indicative of better manual dexterity.
measure: Nine Hole Peg Test
time frame: 14 weeks
description: The Nine-Hole Peg Test is used to measure finger dexterity by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible. Scores are based on the time taken to complete the test activity, recorded in seconds.
measure: World Health Organization Quality of Life (WHOQOL-BREF)-Taiwan version
time frame: 14 weeks
description: The World Health Organization Quality of Life (WHOQOL-BREF) is a 28-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (4 items), and environmental health (9 items); with another 2 items about general condition and overall quality of life. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. The higher scores equals better quality of life.
arm group label: Botulinum toxin, hand robot training, occupational therapy
arm group type: Experimental
description: Patient would receive Botulinum toxin (Injections of 100~400U of Botox in the upper limb muscle with a 2ml/100U dilution), robot-assisted therapy (Hand of Hope training), and standard occupational therapy.
arm group label: Botulinum toxin, occupational therapy
arm group type: Active Comparator
description: Patient would receive Botulinum toxin (Injections of 100~400U of Botox in the upper limb muscle with a 2ml/100U dilution) and standard occupational therapy.
intervention type: Device
intervention name: Hand of Hope
description: A virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot.
arm group label: Botulinum toxin, hand robot training, occupational therapy
intervention type: Drug
intervention name: Botulinum toxin type A injection
description: A safe agent representing the gold standard treatment for focal spasticity.
arm group label: Botulinum toxin, hand robot training, occupational therapy
arm group label: Botulinum toxin, occupational therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Szu-Fu Chen
phone: +886-2-28264400
phone ext: 3806
email: szufuchen@yahoo.com.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA
sharing ipd: Undecided