<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/NCT01724164</url>
  </required_header>
  <id_info>
    <org_study_id>201003058R</org_study_id>
    <nct_id>NCT01724164</nct_id>
  </id_info>
  <brief_title>Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients</brief_title>
  <official_title>Robot- Versus Mirror-Assisted Motor Interventions in Rehabilitating Upper-Limb Motor and Muscle Performance and Daily Functions Poststroke: A Comparative Effectiveness Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this proposal is 1) to compare the relative effects of the robotic&#xD;
      rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare&#xD;
      the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the&#xD;
      RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will&#xD;
      potentially influence the functional outcomes after interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Emerging stroke rehabilitation therapies have shown promise for improving motor recovery&#xD;
      after stroke and involve elements of high-intensity and repetitive task-specific practice,&#xD;
      which might be the essential elements of treatment success. Two prominent examples of&#xD;
      advances in innovative rehabilitation therapies after stroke include robotic rehabilitation&#xD;
      (RR) and mirror therapy (MT). Based on the development of mechanical and biomedical&#xD;
      engineering, RR has emerged that incorporates therapeutic elements for success in motor&#xD;
      rehabilitation: high-intensity, repetitiveness, task-specificity, feedback, and bilateral&#xD;
      training into its design. MT has been proposed in the light of translational research of&#xD;
      mirror neurons. In MT, patients place a mirror beside the unaffected limb to block their view&#xD;
      of the affected limb, creating the illusion that both limbs are intact. The motor visual&#xD;
      input from MT facilitates the activations in the premotor, primary motor and somatosensory&#xD;
      areas, which enhance sensory, perception and motor abilities. The MT may be used to restore&#xD;
      sensory functions, improve grip/grasp strength and motor function. In addition, an innovative&#xD;
      technology, functional electrical stimulation (FES), is proposed as an adjunct to assist in&#xD;
      movement execution and increase the electric activity of muscles for movement and the active&#xD;
      range of motion in patients with low functioning. Robotic rehabilitation that emphasizes&#xD;
      muscle strengthening and motor restoration may be implemented in combination with the FES to&#xD;
      improve treatment outcomes in stroke patients with moderate-to-severe motor impairments in&#xD;
      movement performance and functional outcomes. Despite these promises, research studies that&#xD;
      investigate comparative efficacy of the rival therapies and the effects of combined therapy&#xD;
      relative to mono-therapy are lacking. An additional gap in contemporary neurorehabilitation&#xD;
      is the lack of sufficient information on the threshold values of clinically significant&#xD;
      change in a variety of functional domains relevant for individualized medicine. In addition,&#xD;
      research on the potential vales of biomarkers (eg, level of oxidative stress) for use in&#xD;
      outcomes study in intense rehabilitation falls far behind disciplines of basic sciences. This&#xD;
      proposed research project will be devoted to comparative efficacy trials and clinimetric&#xD;
      study to promote evidence-based neurorehabilitation and translational research in stroke.&#xD;
&#xD;
      It has been called for comparative effectiveness research of the innovative treatments to&#xD;
      promote evidence-based practice and translational science in stroke motor rehabilitation.&#xD;
      Scientific evidence for comparative effectiveness research of RR versus MT on functional&#xD;
      outcomes (e.g., motor, muscle, sensory, and daily functions) and adverse physiological&#xD;
      responses (e.g., fatigue and oxidative responses) in stroke patients is limited. More&#xD;
      rigorous studies are needed to compare the efficacy of RR and MT with control intervention&#xD;
      (CI), to identify the predictors of treatment success, and to study change in functions&#xD;
      (motor, muscle, sensory, and daily) and level of fatigue and oxidative stress after intense&#xD;
      training in order to promote translational science in movement therapy. Therefore, this&#xD;
      comparative efficacy research aims at performing a randomized controlled trial (RCT) to (1)&#xD;
      verify the efficacy and motor control mechanisms of dose-matched RR, MT, and CI; (2) examine&#xD;
      whether RR combined with FES will enhance the effect of RR; (3) study the predictors of&#xD;
      treatment outcomes and clinimetric properties of the outcome measures. We hypothesize the RR&#xD;
      and MT groups would produce better performance in motor control, muscle function, sensory&#xD;
      function, daily functions, and quality of life than the CI group. We further hypothesize that&#xD;
      there will be a differential improvements in movement performance and sensory functions&#xD;
      between the RR and MT. Combined therapy of the RR and FES (RR-FES) will enhance the effect of&#xD;
      RR as compared with the RR plus placebo intervention (RR-PI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">July 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>2011/8 to 2013/1 (up to 2 years)</time_frame>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Robotic assisted therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirror Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic rehabilitation with FES</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic Rehabilitation with PI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mirror Therapy</intervention_name>
    <description>This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.</description>
    <arm_group_label>Mirror Therapy</arm_group_label>
    <other_name>MT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Robotic assisted therapy</intervention_name>
    <description>This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).</description>
    <arm_group_label>Robotic assisted therapy</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Robotic Rehabilitation with PI</intervention_name>
    <description>The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.</description>
    <arm_group_label>Robotic Rehabilitation with PI</arm_group_label>
    <other_name>RR with Placebo Intervention (RR-PI)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Robotic rehabilitation with FES</intervention_name>
    <description>This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.</description>
    <arm_group_label>Robotic rehabilitation with FES</arm_group_label>
    <other_name>RR combined Functional Electrical Stimulation (RR-FES)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional Rehabilitation</intervention_name>
    <description>Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.</description>
    <arm_group_label>Conventional Rehabilitation</arm_group_label>
    <other_name>CR</other_name>
    <other_name>Control Treatment</other_name>
    <other_name>CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to provide the written informed consent&#xD;
&#xD;
          -  More than 6 months onset of unilateral stroke&#xD;
&#xD;
          -  An initial 25-56 or 18-50 scores on the upper limb subtest of the Fugl-Meyer&#xD;
             assessment (FMA)&#xD;
&#xD;
          -  Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)&#xD;
&#xD;
          -  Without upper limb fracture within 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent of stroke or seizure episode during the intervention&#xD;
&#xD;
          -  Occurrence of serious or continuous pain on affected upper-extremity&#xD;
&#xD;
          -  History of other neurological disease or severe orthopaedic condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keh-chung Lin, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Occupational Therapy, College of Medicine, National Taiwan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keh-chung Lin, ScD</last_name>
    <phone>886-2-33668180</phone>
    <email>kehchunglin@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hosipital</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>886-2-33668167</phone>
      <email>kehchunglin@ntu.edu.tw</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keh-chung Lin, ScD</last_name>
      <phone>886-2-33668180</phone>
      <email>kehchunglin@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>November 8, 2012</last_update_submitted>
  <last_update_submitted_qc>November 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 9, 2012</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/NCT01724164
org study id: 201003058R
nct id: NCT01724164
lead sponsor: 
has dmc: No
The purpose of this proposal is 1) to compare the relative effects of the robotic
      rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare
      the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the
      RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will
      potentially influence the functional outcomes after interventions.
Emerging stroke rehabilitation therapies have shown promise for improving motor recovery
      after stroke and involve elements of high-intensity and repetitive task-specific practice,
      which might be the essential elements of treatment success. Two prominent examples of
      advances in innovative rehabilitation therapies after stroke include robotic rehabilitation
      (RR) and mirror therapy (MT). Based on the development of mechanical and biomedical
      engineering, RR has emerged that incorporates therapeutic elements for success in motor
      rehabilitation: high-intensity, repetitiveness, task-specificity, feedback, and bilateral
      training into its design. MT has been proposed in the light of translational research of
      mirror neurons. In MT, patients place a mirror beside the unaffected limb to block their view
      of the affected limb, creating the illusion that both limbs are intact. The motor visual
      input from MT facilitates the activations in the premotor, primary motor and somatosensory
      areas, which enhance sensory, perception and motor abilities. The MT may be used to restore
      sensory functions, improve grip/grasp strength and motor function. In addition, an innovative
      technology, functional electrical stimulation (FES), is proposed as an adjunct to assist in
      movement execution and increase the electric activity of muscles for movement and the active
      range of motion in patients with low functioning. Robotic rehabilitation that emphasizes
      muscle strengthening and motor restoration may be implemented in combination with the FES to
      improve treatment outcomes in stroke patients with moderate-to-severe motor impairments in
      movement performance and functional outcomes. Despite these promises, research studies that
      investigate comparative efficacy of the rival therapies and the effects of combined therapy
      relative to mono-therapy are lacking. An additional gap in contemporary neurorehabilitation
      is the lack of sufficient information on the threshold values of clinically significant
      change in a variety of functional domains relevant for individualized medicine. In addition,
      research on the potential vales of biomarkers (eg, level of oxidative stress) for use in
      outcomes study in intense rehabilitation falls far behind disciplines of basic sciences. This
      proposed research project will be devoted to comparative efficacy trials and clinimetric
      study to promote evidence-based neurorehabilitation and translational research in stroke.

      It has been called for comparative effectiveness research of the innovative treatments to
      promote evidence-based practice and translational science in stroke motor rehabilitation.
      Scientific evidence for comparative effectiveness research of RR versus MT on functional
      outcomes (e.g., motor, muscle, sensory, and daily functions) and adverse physiological
      responses (e.g., fatigue and oxidative responses) in stroke patients is limited. More
      rigorous studies are needed to compare the efficacy of RR and MT with control intervention
      (CI), to identify the predictors of treatment success, and to study change in functions
      (motor, muscle, sensory, and daily) and level of fatigue and oxidative stress after intense
      training in order to promote translational science in movement therapy. Therefore, this
      comparative efficacy research aims at performing a randomized controlled trial (RCT) to (1)
      verify the efficacy and motor control mechanisms of dose-matched RR, MT, and CI; (2) examine
      whether RR combined with FES will enhance the effect of RR; (3) study the predictors of
      treatment outcomes and clinimetric properties of the outcome measures. We hypothesize the RR
      and MT groups would produce better performance in motor control, muscle function, sensory
      function, daily functions, and quality of life than the CI group. We further hypothesize that
      there will be a differential improvements in movement performance and sensory functions
      between the RR and MT. Combined therapy of the RR and FES (RR-FES) will enhance the effect of
      RR as compared with the RR plus placebo intervention (RR-PI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Fugl-Meyer Assessment (FMA)
time frame: 2011/8 to 2013/1 (up to 2 years)
arm group label: Robotic assisted therapy
arm group type: Experimental
description: This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
arm group label: Mirror Therapy
arm group type: Experimental
description: This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
arm group label: Conventional Rehabilitation
arm group type: Active Comparator
description: Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
arm group label: Robotic rehabilitation with FES
arm group type: Experimental
description: This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
arm group label: Robotic Rehabilitation with PI
arm group type: Placebo Comparator
description: The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
intervention type: Behavioral
intervention name: Mirror Therapy
description: This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
arm group label: Mirror Therapy
other name: MT
intervention type: Behavioral
intervention name: Robotic assisted therapy
description: This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
arm group label: Robotic assisted therapy
other name: RT
intervention type: Behavioral
intervention name: Robotic Rehabilitation with PI
description: The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
arm group label: Robotic Rehabilitation with PI
other name: RR with Placebo Intervention (RR-PI)
intervention type: Behavioral
intervention name: Robotic rehabilitation with FES
description: This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
arm group label: Robotic rehabilitation with FES
other name: RR combined Functional Electrical Stimulation (RR-FES)
intervention type: Behavioral
intervention name: Conventional Rehabilitation
description: Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
arm group label: Conventional Rehabilitation
other name: CR
other name: Control Treatment
other name: CT
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Keh-chung Lin, ScD
role: Principal Investigator
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University
last name: Keh-chung Lin, ScD
phone: 886-2-33668180
email: kehchunglin@ntu.edu.tw
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke