<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/NCT04446273</url>
  </required_header>
  <id_info>
    <org_study_id>202004105RINB</org_study_id>
    <nct_id>NCT04446273</nct_id>
  </id_info>
  <brief_title>Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke</brief_title>
  <official_title>Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a single-blind randomized comparative efficacy study involving 40 participants with&#xD;
      chronic stroke. Participants will be randomized into proximal priority robotic group or&#xD;
      distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6&#xD;
      weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale,&#xD;
      Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at&#xD;
      baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis&#xD;
      of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine&#xD;
      the comparative efficacy and predictors of outcome, respectively, after intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background. The sequence of establishing proximal stability or function before facilitation&#xD;
      of the distal body part has long been recognized in stroke rehabilitation practice but lacks&#xD;
      scientific evidence. This study plans to examine the effects of proximal priority robotic&#xD;
      priming and impairment-oriented training (PRI) and distal priority robotic priming and&#xD;
      impairment-oriented training (DRI).&#xD;
&#xD;
      Methods. This is a single-blind randomized comparative efficacy study involving 40&#xD;
      participants with chronic stroke. Participants will be randomized into PRI or DRI groups and&#xD;
      receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment&#xD;
      Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory&#xD;
      Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment,&#xD;
      and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the&#xD;
      Chi-Square Automatic Interaction Detector Method will be used to examine the comparative&#xD;
      efficacy and predictors of outcome, respectively, after PRI and DRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>
    <intervention_model_description>Participants will be randomized into the proximal priority robotic priming and impairment-oriented training or the distal priority robotic priming and impairment-oriented training groups and receive 18 intervention sessions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Initial and outcome assessments will be administered by a well-trained and certified occupational therapist who is blinded to the group assignment, study hypotheses, and intervention of the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Fugl-Meyer Assessment will be administered to participants at baseline.</time_frame>
    <description>Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Fugl-Meyer Assessment will be administered to participants at immediately after intervention.</time_frame>
    <description>Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment</measure>
    <time_frame>Fugl-Meyer Assessment will be administered to participants at three months after intervention.</time_frame>
    <description>Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Research Council Scale</measure>
    <time_frame>Medical Research Council Scale will be administered to participants at baseline.</time_frame>
    <description>Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Research Council Scale</measure>
    <time_frame>Medical Research Council Scale will be administered to participants immediately after intervention.</time_frame>
    <description>Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical Research Council Scale</measure>
    <time_frame>Medical Research Council Scale will be administered to participants three months after intervention.</time_frame>
    <description>Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ABILHAND Questionnaire</measure>
    <time_frame>The ABILHAND Questionnaire will be administered to participants at baseline.</time_frame>
    <description>The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ABILHAND Questionnaire</measure>
    <time_frame>The ABILHAND Questionnaire will be administered to participants immediately after intervention..</time_frame>
    <description>The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ABILHAND Questionnaire</measure>
    <time_frame>The ABILHAND Questionnaire will be administered to participants three months after intervention..</time_frame>
    <description>The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stoke Impact Scale 3.0</measure>
    <time_frame>The Stoke Impact Scale 3.0 will be administered to participants at baseline.</time_frame>
    <description>The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stoke Impact Scale 3.0</measure>
    <time_frame>The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.</time_frame>
    <description>The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stoke Impact Scale 3.0</measure>
    <time_frame>The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.</time_frame>
    <description>The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stroke Self-Efficacy Questionnaire</measure>
    <time_frame>The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.</time_frame>
    <description>The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stroke Self-Efficacy Questionnaire</measure>
    <time_frame>The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.</time_frame>
    <description>The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Stroke Self-Efficacy Questionnaire</measure>
    <time_frame>The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.</time_frame>
    <description>The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Wolf Motor Function Test</measure>
    <time_frame>The Wolf Motor Function Test will be administered to participants at baseline.</time_frame>
    <description>The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Wolf Motor Function Test</measure>
    <time_frame>The Wolf Motor Function Test will be administered to participants immediately after intervention.</time_frame>
    <description>The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Wolf Motor Function Test</measure>
    <time_frame>The Wolf Motor Function Test will be administered to participants three months after intervention.</time_frame>
    <description>The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>PRI group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DRI group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bi-Manu-Track</intervention_name>
    <description>The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.</description>
    <arm_group_label>DRI group</arm_group_label>
    <arm_group_label>PRI group</arm_group_label>
    <other_name>impairment-oriented training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The inclusion criteria are age between 20 and 75 years old, more than 3 months after&#xD;
             the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE&#xD;
             motor impairment (i.e., total UE score of the Fugl-Meyer Assessment [FMA] score&#xD;
             between 18 and 56), no severe spasticity in any joints of the affected arm (modified&#xD;
             Ashworth Scale score &lt;3 in any of the affected shoulder, elbow, wrist, and fingers),&#xD;
             able to follow instructions (Mini-Mental State Examination total score &gt;24), no UE&#xD;
             fractures in the past 3 months, and not simultaneously participating in other&#xD;
             medication or rehabilitation studies.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease,&#xD;
             such as epilepsy, or severe health or physical conditions that might impede&#xD;
             participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keh-chung Lin, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kehchung Lin, ScD</last_name>
    <phone>+886233668180</phone>
    <email>kehchunglin@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fongyuan Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keh-chung Lin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keh-chung Lin, ScD</last_name>
      <phone>886 233668180</phone>
      <email>kehchunglin@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Upper extremity rehabilitation</keyword>
  <keyword>Proximal priority</keyword>
  <keyword>Distal priority</keyword>
  <keyword>Robotic therapy</keyword>
  <keyword>Bilateral motor priming</keyword>
  <keyword>Impairment-oriented training</keyword>
  <keyword>Task-oriented training</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/NCT04446273
org study id: 202004105RINB
nct id: NCT04446273
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single-blind randomized comparative efficacy study involving 40 participants with
      chronic stroke. Participants will be randomized into proximal priority robotic group or
      distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6
      weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale,
      Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at
      baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis
      of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine
      the comparative efficacy and predictors of outcome, respectively, after intervention.
Background. The sequence of establishing proximal stability or function before facilitation
      of the distal body part has long been recognized in stroke rehabilitation practice but lacks
      scientific evidence. This study plans to examine the effects of proximal priority robotic
      priming and impairment-oriented training (PRI) and distal priority robotic priming and
      impairment-oriented training (DRI).

      Methods. This is a single-blind randomized comparative efficacy study involving 40
      participants with chronic stroke. Participants will be randomized into PRI or DRI groups and
      receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment
      Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory
      Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment,
      and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the
      Chi-Square Automatic Interaction Detector Method will be used to examine the comparative
      efficacy and predictors of outcome, respectively, after PRI and DRI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized into the proximal priority robotic priming and impairment-oriented training or the distal priority robotic priming and impairment-oriented training groups and receive 18 intervention sessions
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Initial and outcome assessments will be administered by a well-trained and certified occupational therapist who is blinded to the group assignment, study hypotheses, and intervention of the patients.
measure: Fugl-Meyer Assessment
time frame: Fugl-Meyer Assessment will be administered to participants at baseline.
description: Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.
measure: Fugl-Meyer Assessment
time frame: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
description: Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.
measure: Fugl-Meyer Assessment
time frame: Fugl-Meyer Assessment will be administered to participants at three months after intervention.
description: Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.
measure: Medical Research Council Scale
time frame: Medical Research Council Scale will be administered to participants at baseline.
description: Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
measure: Medical Research Council Scale
time frame: Medical Research Council Scale will be administered to participants immediately after intervention.
description: Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
measure: Medical Research Council Scale
time frame: Medical Research Council Scale will be administered to participants three months after intervention.
description: Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.
measure: The ABILHAND Questionnaire
time frame: The ABILHAND Questionnaire will be administered to participants at baseline.
description: The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
measure: The ABILHAND Questionnaire
time frame: The ABILHAND Questionnaire will be administered to participants immediately after intervention..
description: The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
measure: The ABILHAND Questionnaire
time frame: The ABILHAND Questionnaire will be administered to participants three months after intervention..
description: The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).
measure: The Stoke Impact Scale 3.0
time frame: The Stoke Impact Scale 3.0 will be administered to participants at baseline.
description: The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
measure: The Stoke Impact Scale 3.0
time frame: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.
description: The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
measure: The Stoke Impact Scale 3.0
time frame: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.
description: The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.
measure: The Stroke Self-Efficacy Questionnaire
time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.
description: The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
measure: The Stroke Self-Efficacy Questionnaire
time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.
description: The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
measure: The Stroke Self-Efficacy Questionnaire
time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.
description: The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.
measure: The Wolf Motor Function Test
time frame: The Wolf Motor Function Test will be administered to participants at baseline.
description: The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
measure: The Wolf Motor Function Test
time frame: The Wolf Motor Function Test will be administered to participants immediately after intervention.
description: The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
measure: The Wolf Motor Function Test
time frame: The Wolf Motor Function Test will be administered to participants three months after intervention.
description: The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.
arm group label: PRI group
arm group type: Experimental
description: The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist).
arm group label: DRI group
arm group type: Active Comparator
description: The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).
intervention type: Device
intervention name: Bi-Manu-Track
description: The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.
arm group label: DRI group
arm group label: PRI group
other name: impairment-oriented training
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Keh-chung Lin, ScD
role: Principal Investigator
affiliation: National Taiwan University
last name: Kehchung Lin, ScD
phone: +886233668180
email: kehchunglin@ntu.edu.tw
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No