<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/NCT03817385</url>
  </required_header>
  <id_info>
    <org_study_id>CCH-160102</org_study_id>
    <nct_id>NCT03817385</nct_id>
  </id_info>
  <brief_title>rTMS and Robotic Gait Training in Patients With Stroke</brief_title>
  <official_title>Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) and Robotic Gait Training on Lower-extremity Function and Gait in Patients With Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian 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>
      Patients with stroke have demonstrated abnormal muscle tone and postural control ability&#xD;
      which affect their ambulation, activity of daily living and confident. Nowadays, utilizing&#xD;
      repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking&#xD;
      training for stroke patients has been applied to clinic widely. While less studies have&#xD;
      compared intervention efficacy for stroke patients between rTMS and robotic training. This&#xD;
      study aimed to compare effect of rTMS and robotic training for lower-extremity function and&#xD;
      gait in stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will include subjects occurring stroke within 3 months. All groups will receive&#xD;
      traditional rehabilitation. The subjects will be allocated randomly in three groups which are&#xD;
      traditional rehabilitation (Group A), robotic training (Group B), and rTMS (Group C)&#xD;
      respectively, with 35 people per group. The group B will be intervened 5 times per week and&#xD;
      the group C will receive 10 times rTMS intervention during 4 weeks. At post-intervention and&#xD;
      eighth weeks after intervention, basic examination will be executed including basic&#xD;
      information, history, Mini-mental State examination, Short -Form 36, Modified Ashworth Scale,&#xD;
      Fugl-Meyer assessment, static and dynamic motion examination, ultrasound assessment and&#xD;
      examination of cardiorespiratory. Two-way mixed ANOVA will be used to analyze the differences&#xD;
      of three groups and times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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 walking speed</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway displacement</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure the postural sway displacement (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway velocity</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure the postural sway velocity (mm/s)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of postural sway area</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>computerized dynography to measure the postural sway area (mm^2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of step time</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: step time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of stance time</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: stance time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of swing time</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: swing time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of single support time</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: single support time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of double support time</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: double support time (ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of step length</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: step distance (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of stance length</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Use computerized dynography to measure spatial gait parameter: stance distance (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of amplitude of Muscle activity</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self selected speed in 6 meters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of Functional Independence Measure (FIM)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.&#xD;
The motor subscale includes:&#xD;
Eating Grooming Bathing Dressing, upper body Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchair Transfers - toilet Transfers - bath/shower Walk/wheelchair Stairs&#xD;
The cognition subscale includes:&#xD;
Comprehension Expression Social interaction Problem solving Memory Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.&#xD;
The total score for the FIM motor subscale will be a value between 13 and 91. The total score for the FIM cognition subscale will be a value between 5 and 35.&#xD;
The total score for the FIM instrument will be a value between 18 and 126.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of international Quality of Life Assessment Short Form -36 (SF-36)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.&#xD;
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Serum albumin</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>The concentration of Serum albumin in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.&#xD;
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Hemoglobin (Hb)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>The concentration of Hb in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Glucose</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>The concentration of Glucose in the blood test. The Spot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Cholesterol</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>The concentration of Cholesterol in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of concentration of Triglyceride</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>The concentration of Triglyceride in the blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Berg balance test (BBS)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.&#xD;
The item scores are summed, minimum score =0, maximum score = 56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (Upper extremity maximum score = 66; Lower extremity maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Body Mass Index (BMI)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>(body weight) kg/(height) m*(height)m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Mini-mental state examination (MMSE)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>It is an 11-question measure that tests five areas of cognitive function:&#xD;
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Modified Ashworth scale (MAS)</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone&#xD;
Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM)&#xD;
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved&#xD;
Considerable increase in muscle tone, passive movement difficult&#xD;
Affected part(s) rigid in flexion or extension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Muscle tone</measure>
    <time_frame>baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention</time_frame>
    <description>measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>repetitive TMS (Transcranial Magnetic Stimulation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rTMS and physical / occupational therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>robotic GT (Gait Training)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>robotic gait training for 20 times and physical / occupational therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional rehabilitation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patient only received traditional rehabilitation program</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>repetitive TMS</intervention_name>
    <description>rTMS x 10 times</description>
    <arm_group_label>repetitive TMS (Transcranial Magnetic Stimulation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>robotic GT</intervention_name>
    <description>robotic gait training for 20 times</description>
    <arm_group_label>robotic GT (Gait Training)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first-time onset of stroke&#xD;
&#xD;
          -  reaching 20 years old and having clinical CT and MRI diagnosis of stroke&#xD;
&#xD;
          -  hemiparesis with sitting ability after onset 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brunnstrom stage over grade V&#xD;
&#xD;
          -  Combined other neurological diseases (epilepsy, polyneuropathy, Meniere's disease,&#xD;
             vestibular neuritis, Parkinson's disease, dementia, spinocerebellar ataxia)&#xD;
&#xD;
          -  lower extremity disease, included joint contracture, high muscle tone(MAS more than&#xD;
             3), L/E fracture, Joint replacement, long-term osteoarthritis pain&#xD;
&#xD;
          -  unstable vital sign&#xD;
&#xD;
          -  can't coordinate or Sign consent plan form&#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>Ta-Sen Wei, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PangTa Liu</last_name>
    <phone>886-4-7238595</phone>
    <phone_ext>7427</phone_ext>
    <email>105546@cch.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tasen Wei</last_name>
      <phone>886-4-7238595</phone>
      <phone_ext>7416</phone_ext>
      <email>tasen@cch.org.tw</email>
    </contact>
    <investigator>
      <last_name>Tasen Wei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Brunt D, Greenberg B, Wankadia S, Trimble MA, Shechtman O. The effect of foot placement on sit to stand in healthy young subjects and patients with hemiplegia. Arch Phys Med Rehabil. 2002 Jul;83(7):924-9. doi: 10.1053/apmr.2002.3324.</citation>
    <PMID>12098151</PMID>
  </reference>
  <reference>
    <citation>Dettmann MA, Linder MT, Sepic SB. Relationships among walking performance, postural stability, and functional assessments of the hemiplegic patient. Am J Phys Med. 1987 Apr;66(2):77-90.</citation>
    <PMID>3578493</PMID>
  </reference>
  <reference>
    <citation>Hidler J, Nichols D, Pelliccio M, Brady K. Advances in the understanding and treatment of stroke impairment using robotic devices. Top Stroke Rehabil. 2005 Spring;12(2):22-35. doi: 10.1310/RYT5-62N4-CTVX-8JTE.</citation>
    <PMID>15940582</PMID>
  </reference>
  <reference>
    <citation>Kakuda W, Abo M, Watanabe S, Momosaki R, Hashimoto G, Nakayama Y, Kiyama A, Yoshida H. High-frequency rTMS applied over bilateral leg motor areas combined with mobility training for gait disturbance after stroke: a preliminary study. Brain Inj. 2013;27(9):1080-6. doi: 10.3109/02699052.2013.794973.</citation>
    <PMID>23834634</PMID>
  </reference>
  <reference>
    <citation>Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.</citation>
    <PMID>25488849</PMID>
  </reference>
  <reference>
    <citation>Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143.</citation>
    <PMID>18467648</PMID>
  </reference>
  <reference>
    <citation>Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. doi: 10.2522/ptj.20050266.</citation>
    <PMID>17079746</PMID>
  </reference>
  <reference>
    <citation>Kim P, Warren S, Madill H, Hadley M. Quality of life of stroke survivors. Qual Life Res. 1999 Jun;8(4):293-301. doi: 10.1023/a:1008927431300.</citation>
    <PMID>10472161</PMID>
  </reference>
  <reference>
    <citation>Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.</citation>
    <PMID>16151035</PMID>
  </reference>
  <reference>
    <citation>Ng SS, Hui-Chan CW. The timed up &amp; go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.</citation>
    <PMID>16084820</PMID>
  </reference>
  <reference>
    <citation>Nichols DS. Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 May;77(5):553-8. doi: 10.1093/ptj/77.5.553.</citation>
    <PMID>9149764</PMID>
  </reference>
  <reference>
    <citation>Wang RY, Tseng HY, Liao KK, Wang CJ, Lai KL, Yang YR. rTMS combined with task-oriented training to improve symmetry of interhemispheric corticomotor excitability and gait performance after stroke: a randomized trial. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):222-30. doi: 10.1177/1545968311423265. Epub 2011 Oct 5.</citation>
    <PMID>21974983</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>Ta-Sen Wei,MD</investigator_full_name>
    <investigator_title>Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Transcranial magnetic stimulation</keyword>
  <keyword>Robotic gait training</keyword>
  <keyword>Gait</keyword>
  <keyword>Spasticity</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>
    <ipd_description>only for research</ipd_description>
  </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/NCT03817385
org study id: CCH-160102
nct id: NCT03817385
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with stroke have demonstrated abnormal muscle tone and postural control ability
      which affect their ambulation, activity of daily living and confident. Nowadays, utilizing
      repetitive transcranial magnetic stimulation (rTMS) and robotic machines to assist walking
      training for stroke patients has been applied to clinic widely. While less studies have
      compared intervention efficacy for stroke patients between rTMS and robotic training. This
      study aimed to compare effect of rTMS and robotic training for lower-extremity function and
      gait in stroke patients.
This study will include subjects occurring stroke within 3 months. All groups will receive
      traditional rehabilitation. The subjects will be allocated randomly in three groups which are
      traditional rehabilitation (Group A), robotic training (Group B), and rTMS (Group C)
      respectively, with 35 people per group. The group B will be intervened 5 times per week and
      the group C will receive 10 times rTMS intervention during 4 weeks. At post-intervention and
      eighth weeks after intervention, basic examination will be executed including basic
      information, history, Mini-mental State examination, Short -Form 36, Modified Ashworth Scale,
      Fugl-Meyer assessment, static and dynamic motion examination, ultrasound assessment and
      examination of cardiorespiratory. Two-way mixed ANOVA will be used to analyze the differences
      of three groups and times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of walking speed
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: walk 6m to measure the time spent, patients can walk with foot orthosis and assistive devices
measure: Change of postural sway displacement
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure the postural sway displacement (mm)
measure: Change of postural sway velocity
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure the postural sway velocity (mm/s)
measure: Change of postural sway area
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: computerized dynography to measure the postural sway area (mm^2)
measure: Change of step time
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: step time (ms)
measure: Change of stance time
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: stance time (ms)
measure: Change of swing time
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: swing time (ms)
measure: Change of single support time
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: single support time (ms)
measure: Change of double support time
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: double support time (ms)
measure: Change of step length
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: step distance (mm)
measure: Change of stance length
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Use computerized dynography to measure spatial gait parameter: stance distance (mm)
measure: Change of amplitude of Muscle activity
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self selected speed in 6 meters.
measure: Change of Functional Independence Measure (FIM)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.
The motor subscale includes:
Eating Grooming Bathing Dressing, upper body Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchair Transfers - toilet Transfers - bath/shower Walk/wheelchair Stairs
The cognition subscale includes:
Comprehension Expression Social interaction Problem solving Memory Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
The total score for the FIM motor subscale will be a value between 13 and 91. The total score for the FIM cognition subscale will be a value between 5 and 35.
The total score for the FIM instrument will be a value between 18 and 126.
measure: Change of international Quality of Life Assessment Short Form -36 (SF-36)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
measure: Change of concentration of Serum albumin
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: The concentration of Serum albumin in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions.
Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale.
measure: Change of concentration of Hemoglobin (Hb)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: The concentration of Hb in the blood test.
measure: Change of concentration of Glucose
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: The concentration of Glucose in the blood test. The Spot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation
measure: Change of concentration of Cholesterol
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: The concentration of Cholesterol in the blood test.
measure: Change of concentration of Triglyceride
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: The concentration of Triglyceride in the blood test.
measure: Change of Berg balance test (BBS)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.
The item scores are summed, minimum score =0, maximum score = 56
measure: Change of Fugl-Meyer Assessment (FMA)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (Upper extremity maximum score = 66; Lower extremity maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)
measure: Change of Body Mass Index (BMI)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: (body weight) kg/(height) m*(height)m
measure: Change of Mini-mental state examination (MMSE)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: It is an 11-question measure that tests five areas of cognitive function:
orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.
measure: Change of Modified Ashworth scale (MAS)
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone
Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion (ROM)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
measure: Change of Muscle tone
time frame: baseline: before intervention, 1st examination: finish the intervention(repetitiveTMS:10 times treatments(2weeks)；robotic GT:20 times treatments (4weeks)), 2nd examination: 7 weeks after intervention
description: measure the muscle tone (kg/m) under muscle resting. Target muscles are quadriceps, hamstrings, anterior tibialis, gastrocnemius.
arm group label: repetitive TMS (Transcranial Magnetic Stimulation)
arm group type: Experimental
description: rTMS and physical / occupational therapy
arm group label: robotic GT (Gait Training)
arm group type: Experimental
description: robotic gait training for 20 times and physical / occupational therapy
arm group label: traditional rehabilitation
arm group type: No Intervention
description: patient only received traditional rehabilitation program
intervention type: Device
intervention name: repetitive TMS
description: rTMS x 10 times
arm group label: repetitive TMS (Transcranial Magnetic Stimulation)
intervention type: Device
intervention name: robotic GT
description: robotic gait training for 20 times
arm group label: robotic GT (Gait Training)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ta-Sen Wei, Doctor
role: Principal Investigator
affiliation: Changhua Christian Hospital
last name: PangTa Liu
phone: 886-4-7238595
phone ext: 7427
email: 105546@cch.org.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
citation: Brunt D, Greenberg B, Wankadia S, Trimble MA, Shechtman O. The effect of foot placement on sit to stand in healthy young subjects and patients with hemiplegia. Arch Phys Med Rehabil. 2002 Jul;83(7):924-9. doi: 10.1053/apmr.2002.3324.
PMID: 12098151
citation: Dettmann MA, Linder MT, Sepic SB. Relationships among walking performance, postural stability, and functional assessments of the hemiplegic patient. Am J Phys Med. 1987 Apr;66(2):77-90.
PMID: 3578493
citation: Hidler J, Nichols D, Pelliccio M, Brady K. Advances in the understanding and treatment of stroke impairment using robotic devices. Top Stroke Rehabil. 2005 Spring;12(2):22-35. doi: 10.1310/RYT5-62N4-CTVX-8JTE.
PMID: 15940582
citation: Kakuda W, Abo M, Watanabe S, Momosaki R, Hashimoto G, Nakayama Y, Kiyama A, Yoshida H. High-frequency rTMS applied over bilateral leg motor areas combined with mobility training for gait disturbance after stroke: a preliminary study. Brain Inj. 2013;27(9):1080-6. doi: 10.3109/02699052.2013.794973.
PMID: 23834634
citation: Kim J, Park JH, Yim J. Effects of respiratory muscle and endurance training using an individualized training device on the pulmonary function and exercise capacity in stroke patients. Med Sci Monit. 2014 Dec 5;20:2543-9. doi: 10.12659/MSM.891112.
PMID: 25488849
citation: Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008 Jun;39(6):1786-92. doi: 10.1161/STROKEAHA.107.504779. Epub 2008 May 8. Erratum In: Stroke.2008 Aug;39(8): e143.
PMID: 18467648
citation: Israel JF, Campbell DD, Kahn JH, Hornby TG. Metabolic costs and muscle activity patterns during robotic- and therapist-assisted treadmill walking in individuals with incomplete spinal cord injury. Phys Ther. 2006 Nov;86(11):1466-78. doi: 10.2522/ptj.20050266.
PMID: 17079746
citation: Kim P, Warren S, Madill H, Hadley M. Quality of life of stroke survivors. Qual Life Res. 1999 Jun;8(4):293-301. doi: 10.1023/a:1008927431300.
PMID: 10472161
citation: Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.
PMID: 16151035
citation: Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil. 2005 Aug;86(8):1641-7. doi: 10.1016/j.apmr.2005.01.011.
PMID: 16084820
citation: Nichols DS. Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 May;77(5):553-8. doi: 10.1093/ptj/77.5.553.
PMID: 9149764
citation: Wang RY, Tseng HY, Liao KK, Wang CJ, Lai KL, Yang YR. rTMS combined with task-oriented training to improve symmetry of interhemispheric corticomotor excitability and gait performance after stroke: a randomized trial. Neurorehabil Neural Repair. 2012 Mar-Apr;26(3):222-30. doi: 10.1177/1545968311423265. Epub 2011 Oct 5.
PMID: 21974983
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: Ta-Sen Wei,MD
investigator title: Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor
mesh term: Stroke
sharing ipd: No
ipd description: only for research