<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/NCT03750526</url>
  </required_header>
  <id_info>
    <org_study_id>N201703084</org_study_id>
    <nct_id>NCT03750526</nct_id>
  </id_info>
  <brief_title>Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation</brief_title>
  <official_title>Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University 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>
      This study is to investigate the combined effects of repetitive Transcranial Magnetic&#xD;
      Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance,&#xD;
      gait, activity in individuals with stroke. Forty participants will be recruited in this&#xD;
      study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group&#xD;
      (10), AR group (10), and conventional physiotherapy group (10).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR&#xD;
      group, AR group ,and conventional physiotherapy group in current study. All participants&#xD;
      underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor&#xD;
      evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer&#xD;
      Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for&#xD;
      Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before&#xD;
      and after intervention in all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</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>Change of Time Up Go test (TUG)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Berg Balance Scale (BBS)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Motor evoked potential (MEP)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Fugl-Meyer Assessment (FMA)-Lower extremity</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Multi-directional Reach Test (MDRT)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of The Postural Assessment Scale for Stroke Patients (PASS)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Taiwanese Depression Questionnaires (TDQ)</measure>
    <time_frame>Measurement before and after intervention ( week 0 and at the end of week 4) in four groups</time_frame>
    <description>Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of &quot;how often you felt the physical and emotional aspects during the past week&quot;. Zero denotes never, three means always. TDQ scores range from 0 to 54.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>rTMS and AR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham rTMS and AR group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional physiotherapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>rTMS and AR</intervention_name>
    <description>rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.</description>
    <arm_group_label>rTMS and AR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham rTMS and AR</intervention_name>
    <description>Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.</description>
    <arm_group_label>Sham rTMS and AR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AR</intervention_name>
    <description>AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.</description>
    <arm_group_label>AR group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Conventional physiotherapy</intervention_name>
    <description>Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.</description>
    <arm_group_label>Conventional physiotherapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cognitive ability is sufficient to understand the nature of study (Mini-Mental State&#xD;
             Examination score was above 23).&#xD;
&#xD;
          2. Participants suffer from unilateral hemiplegia caused by a first-ever stroke.&#xD;
&#xD;
          3. Participants are stable in medical and psychological condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants have other neurologic problems that can affect balance and walking&#xD;
             ability.&#xD;
&#xD;
          2. Participants take of drugs or have other medical condition that can affect balance and&#xD;
             function.&#xD;
&#xD;
          3. Participants have contraindications for rTMS intervention such as pacemaker, cochlear&#xD;
             implants, metal in the brain or skull, open wound of brain, or history of epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chien-Hung Lai, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chien-Hung Lai, MD PhD</last_name>
    <phone>886-2-27372181</phone>
    <phone_ext>3538</phone_ext>
    <email>chlai@tmu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Taipei Medical university Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chien-Hung Lai, MD PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University Hospital</investigator_affiliation>
    <investigator_full_name>Lai chien hung</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Repetitive transcranial magnetic stimulation (rTMS)</keyword>
  <keyword>Augmented reality (AR)</keyword>
  <keyword>stroke</keyword>
  <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/NCT03750526
org study id: N201703084
nct id: NCT03750526
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is to investigate the combined effects of repetitive Transcranial Magnetic
      Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance,
      gait, activity in individuals with stroke. Forty participants will be recruited in this
      study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group
      (10), AR group (10), and conventional physiotherapy group (10).
Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR
      group, AR group ,and conventional physiotherapy group in current study. All participants
      underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor
      evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer
      Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for
      Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before
      and after intervention in all participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of Time Up Go test (TUG)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
measure: Change of Berg Balance Scale (BBS)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
measure: Change of Motor evoked potential (MEP)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
measure: Change of Fugl-Meyer Assessment (FMA)-Lower extremity
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
measure: Change of Multi-directional Reach Test (MDRT)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: Participants will be required to reach in the forward, left and right directions. The test is performed with the participant in standing. It is the measure of the difference, in centimeters, between arm's length with arms at 90° flexion/ abduction and maximal forward, left and right directions reaching respectively, using a fixed base of support. The test uses a centimeters measuring device against a wall at shoulder height.
measure: Change of The Postural Assessment Scale for Stroke Patients (PASS)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: The Postural Assessment Scale for Stroke Patients (PASS) is a postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The PASS consists of 2 sections with a 4-point scale to describe each task. The total score ranges from 0 - 36. A score of 0 denotes the inability of the participant to perform the task, and a score of 3 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 36.
measure: Change of Taiwanese Depression Questionnaires (TDQ)
time frame: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
description: Taiwanese Depression Questionnaires (TDQ) contains 18 items to screen the situation of depression within a week. The TDQ, which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". Zero denotes never, three means always. TDQ scores range from 0 to 54.
arm group label: rTMS and AR group
arm group type: Experimental
description: Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
arm group label: Sham rTMS and AR group
arm group type: Active Comparator
description: Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
arm group label: AR group
arm group type: Active Comparator
description: Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
arm group label: Conventional physiotherapy group
arm group type: Active Comparator
description: Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
intervention type: Behavioral
intervention name: rTMS and AR
description: rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
arm group label: rTMS and AR group
intervention type: Behavioral
intervention name: Sham rTMS and AR
description: Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
arm group label: Sham rTMS and AR group
intervention type: Behavioral
intervention name: AR
description: AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
arm group label: AR group
intervention type: Behavioral
intervention name: Conventional physiotherapy
description: Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
arm group label: Conventional physiotherapy group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chien-Hung Lai, MD PhD
role: Principal Investigator
affiliation: Taipei Medical University Hospital
last name: Chien-Hung Lai, MD PhD
phone: 886-2-27372181
phone ext: 3538
email: chlai@tmu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University Hospital
investigator full name: Lai chien hung
investigator title: Professor
mesh term: Stroke