<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/NCT03290833</url>
  </required_header>
  <id_info>
    <org_study_id>TenChenGH</org_study_id>
    <nct_id>NCT03290833</nct_id>
  </id_info>
  <brief_title>Is the Rehabilitation Robotic a Safe and Effective Choice for Stroke Patients?</brief_title>
  <official_title>Is the Rehabilitation Robotic a Safe and Effective Choice for Stroke Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ten-Chen General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chung Yuan Christian University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ten-Chen 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>
      The effectiveness of robotic over conventional therapy is arguable and the best therapy&#xD;
      strategy is still not clear. Basing on the existing evidence on motor learning and&#xD;
      practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand&#xD;
      to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic&#xD;
      system allows intensive and customized training of hand and finger movements. The aim of this&#xD;
      study is (1) to establish whether robot assisted therapy provides any additional motor&#xD;
      recovery for the hand when administered during the subacute stage in a Chinese adult&#xD;
      population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of&#xD;
      robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction The number of incident strokes, prevalent stroke survivors, disability-adjusted&#xD;
      life-years (DALYs) lost due to stroke, and stroke-related deaths is increasing in the word&#xD;
      (1). Stroke is the most common cause of complex disability in Taiwan (2). After the acute&#xD;
      phase of stroke, many patients are left with impairment of upper-limb movement (hemiparesis)&#xD;
      because of the hand weakness and abnormal contractions. Motor recovery of the hand is the&#xD;
      slowest and most difficult, leading to limited hand activities and occupational disability.&#xD;
      Therefore, facilitating motor recovery of hand after stroke is crucial in stroke&#xD;
      rehabilitation.&#xD;
&#xD;
      The mechanisms of recovery after stroke are multifactorial and the effect of rehabilitation&#xD;
      programs is complex (3). Activity-dependent neural plasticity of the cortical maps adjacent&#xD;
      to the lesion probably occurs, particularly during the acute period after stroke (4). In&#xD;
      order to stimulate such plasticity, many new rehabilitation methods, including rehabilitation&#xD;
      robots, have been developed according to the principles of motor learning (5). Robotic&#xD;
      systems can provide repetitive, reproducible, interactive forms of physical therapy that can&#xD;
      be quantified (6). The advantages of using robots in neuromotor rehabilitation includes&#xD;
      favoring attention and reducing the effort of the patient during training (7), boosting&#xD;
      motivation and adherence to treatment (8), as well as help in multi-sensory and sensorimotor&#xD;
      integration (9). Some results are very promising, showing that robot-assisted therapy is safe&#xD;
      and well tolerated and that it has a positive impact on muscle strength and function in the&#xD;
      paretic arm (10-12). However, the quality of these evidence is still controversial and&#xD;
      inconclusive. The effectiveness of robotic over conventional therapy is arguable and the best&#xD;
      therapy strategy is still not clear. Furthermore, there is little understanding of the&#xD;
      neurological mechanisms involved in functional recovery of the hand (13). In this study, the&#xD;
      investigators hypothesize that the robot based assistance would outperform conventional&#xD;
      therapy during the subacute stage of stroke.&#xD;
&#xD;
      Study objective&#xD;
&#xD;
        1. To establish whether robot assisted therapy provides any additional motor recovery for&#xD;
           the hand when administered during the subacute stage in a Chinese adult population&#xD;
           diagnosed with stroke.&#xD;
&#xD;
        2. To evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in&#xD;
           improving arm function abilities in subacute hemiplegic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2017</start_date>
  <completion_date type="Actual">June 9, 2019</completion_date>
  <primary_completion_date type="Actual">June 9, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fugl-Meyer score</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The investigators used FMA scale to evaluate sensorimotor recovery of patients with particular attention to the hand and wrist section (maximum score=24) to assess the functional capacity of the affected hand.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Motricity Index (MI) scale</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The Motricity Index was used to measure strength in upper and lower extremities after stroke. The weighted score based on the ordinal 6 point scale of Medical Research Council was used to measure maximal isometric muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Independence Measure scale (FIM)</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The investigators used FIM to assess the degree of independence and need-of-assistance in basic activities of daily living at enrolment and at the end of the study. FIM is an 18-item ordinal scale rated from 1 (total dependence) to 7 (total independence) per item; 13 items of this scale, the sub-scale Motor- FIM, were used to evaluate motor disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual analogue scale (VAS)</measure>
    <time_frame>Change from baseline to 10 weeks</time_frame>
    <description>The investigators used VAS (0 extremely simple- 10 extremely difficult) to access the feasibility of the device in terms of the number of patients who completed the program.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Robotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive 30 minutes robotic training sessions, 3 times per week for a total of 30 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive schedule (1-hour sessions, 3 times/week, 30 total sessions) of conventional therapy from an occupational therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In conventional therapy group, participants will receive an one-hour of one-on-one treatment (1-hour sessions, 3 times/week, 30 total sessions) from an occupational therapist, focusing on arm and hand function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic</intervention_name>
    <description>Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.</description>
    <arm_group_label>Robotic</arm_group_label>
    <other_name>Conventional therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional therapy</intervention_name>
    <description>An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.</description>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_label>Robotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt;20 years old) with a diagnosis of hemorrhagic or ischemic stroke and&#xD;
             who experience severe upper extremity hemiparesis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe pain and instability in the wrist of the affected arm, severe cognitive&#xD;
             impairment, aphasia, hemispatial neglect, apraxia and joint contractures greater than&#xD;
             20 degrees in the affected hand.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chia-yu Hsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ten-Chan General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ten Chan General Hospital</name>
      <address>
        <city>Taoyuan City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Robotics</keyword>
  <keyword>Stroke</keyword>
  <keyword>Hand</keyword>
  <keyword>neurorehabilitation</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03290833/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03290833
org study id: TenChenGH
nct id: NCT03290833
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The effectiveness of robotic over conventional therapy is arguable and the best therapy
      strategy is still not clear. Basing on the existing evidence on motor learning and
      practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand
      to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic
      system allows intensive and customized training of hand and finger movements. The aim of this
      study is (1) to establish whether robot assisted therapy provides any additional motor
      recovery for the hand when administered during the subacute stage in a Chinese adult
      population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of
      robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic
      patients.
Introduction The number of incident strokes, prevalent stroke survivors, disability-adjusted
      life-years (DALYs) lost due to stroke, and stroke-related deaths is increasing in the word
      (1). Stroke is the most common cause of complex disability in Taiwan (2). After the acute
      phase of stroke, many patients are left with impairment of upper-limb movement (hemiparesis)
      because of the hand weakness and abnormal contractions. Motor recovery of the hand is the
      slowest and most difficult, leading to limited hand activities and occupational disability.
      Therefore, facilitating motor recovery of hand after stroke is crucial in stroke
      rehabilitation.

      The mechanisms of recovery after stroke are multifactorial and the effect of rehabilitation
      programs is complex (3). Activity-dependent neural plasticity of the cortical maps adjacent
      to the lesion probably occurs, particularly during the acute period after stroke (4). In
      order to stimulate such plasticity, many new rehabilitation methods, including rehabilitation
      robots, have been developed according to the principles of motor learning (5). Robotic
      systems can provide repetitive, reproducible, interactive forms of physical therapy that can
      be quantified (6). The advantages of using robots in neuromotor rehabilitation includes
      favoring attention and reducing the effort of the patient during training (7), boosting
      motivation and adherence to treatment (8), as well as help in multi-sensory and sensorimotor
      integration (9). Some results are very promising, showing that robot-assisted therapy is safe
      and well tolerated and that it has a positive impact on muscle strength and function in the
      paretic arm (10-12). However, the quality of these evidence is still controversial and
      inconclusive. The effectiveness of robotic over conventional therapy is arguable and the best
      therapy strategy is still not clear. Furthermore, there is little understanding of the
      neurological mechanisms involved in functional recovery of the hand (13). In this study, the
      investigators hypothesize that the robot based assistance would outperform conventional
      therapy during the subacute stage of stroke.

      Study objective

        1. To establish whether robot assisted therapy provides any additional motor recovery for
           the hand when administered during the subacute stage in a Chinese adult population
           diagnosed with stroke.

        2. To evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in
           improving arm function abilities in subacute hemiplegic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Fugl-Meyer score
time frame: Change from baseline to 10 weeks
description: The investigators used FMA scale to evaluate sensorimotor recovery of patients with particular attention to the hand and wrist section (maximum score=24) to assess the functional capacity of the affected hand.
measure: Change in Motricity Index (MI) scale
time frame: Change from baseline to 10 weeks
description: The Motricity Index was used to measure strength in upper and lower extremities after stroke. The weighted score based on the ordinal 6 point scale of Medical Research Council was used to measure maximal isometric muscle strength.
measure: Change in Functional Independence Measure scale (FIM)
time frame: Change from baseline to 10 weeks
description: The investigators used FIM to assess the degree of independence and need-of-assistance in basic activities of daily living at enrolment and at the end of the study. FIM is an 18-item ordinal scale rated from 1 (total dependence) to 7 (total independence) per item; 13 items of this scale, the sub-scale Motor- FIM, were used to evaluate motor disability.
measure: Change in Visual analogue scale (VAS)
time frame: Change from baseline to 10 weeks
description: The investigators used VAS (0 extremely simple- 10 extremely difficult) to access the feasibility of the device in terms of the number of patients who completed the program.
arm group label: Robotic
arm group type: Experimental
description: The experimental group will receive 30 minutes robotic training sessions, 3 times per week for a total of 30 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive schedule (1-hour sessions, 3 times/week, 30 total sessions) of conventional therapy from an occupational therapist.
arm group label: Conventional
arm group type: Active Comparator
description: In conventional therapy group, participants will receive an one-hour of one-on-one treatment (1-hour sessions, 3 times/week, 30 total sessions) from an occupational therapist, focusing on arm and hand function.
intervention type: Device
intervention name: Robotic
description: Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.
arm group label: Robotic
other name: Conventional therapy
intervention type: Other
intervention name: Conventional therapy
description: An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.
arm group label: Conventional
arm group label: Robotic
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chia-yu Hsu, MD
role: Principal Investigator
affiliation: Ten-Chan General Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No
provided document: 