<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/NCT02993042</url>
  </required_header>
  <id_info>
    <org_study_id>RAGT-GAP</org_study_id>
    <nct_id>NCT02993042</nct_id>
  </id_info>
  <brief_title>Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease</brief_title>
  <official_title>Effect of Robot-assisted Gait Training on Gait Automaticity in Patients With Parkinson's Disease: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by&#xD;
      repeating a normal gait pattern with high intensity. This study is a feasibility study to&#xD;
      investigate whether robot-assisted gait training can be applied to improve walking autonomy&#xD;
      in patients with Parkinson 's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from&#xD;
      the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive&#xD;
      neurodegenerative disease characterized by motor symptoms including gait disturbance and&#xD;
      balance instability. In the early stages of Parkinson's disease, dysfunction of the&#xD;
      sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles.&#xD;
      Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and&#xD;
      the automaticity of walking is reduced. Walking performance in a dual-task condition has been&#xD;
      used to assess gait automaticity in patients with Parkinson's disease.&#xD;
&#xD;
      Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns&#xD;
      at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved&#xD;
      the recovery of independent gait after stroke compared with conventional rehabilitation&#xD;
      therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been&#xD;
      reported to improve walking speed and walking endurance compared to conventional physical&#xD;
      therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has&#xD;
      been reported that in patients with Parkinson's disease with balance impairment,&#xD;
      robot-assisted gait training can improve balance disorder compared with physical therapy, and&#xD;
      gait freezing has improved in some small-scale patients. However, studies on the&#xD;
      effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and&#xD;
      the mechanism of the effect has not been elucidated. In particular, the effect on gait&#xD;
      automaticity, which is a characteristic of Parkinson 's disease, has not been studied.&#xD;
      Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can&#xD;
      be applied to improve walking autonomy in patients with Parkinson's disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of dual-task interference: cognitive</measure>
    <time_frame>at 4 weeks</time_frame>
    <description>(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of dual-task interference: physical</measure>
    <time_frame>at 4 weeks</time_frame>
    <description>(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>10 meter walk test (sec): single, cognitive dual-task, physical dual-task</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Berg balance scale</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Korean version of the Falls Efficacy Scale-International</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step length</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
    <description>Gait analysis using IMU sensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step width</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
    <description>Gait analysis using IMU sensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cadence</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
    <description>Gait analysis using IMU sensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vertical displacement</measure>
    <time_frame>baseline, at 4 weeks, at 8 weeks</time_frame>
    <description>Gait analysis using IMU sensors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of dual-task interference: cognitive</measure>
    <time_frame>baseline, at 8 weeks</time_frame>
    <description>(Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of dual-task interference: physical</measure>
    <time_frame>baseline, at 8 weeks</time_frame>
    <description>(Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <arm_group>
    <arm_group_label>Robot-assisted gait training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&amp;S Mechanics Co. Ltd., Seoul, Korea)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robot-assisted gait training</intervention_name>
    <description>Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.</description>
    <arm_group_label>Robot-assisted gait training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically confirmed patients with idiopathic Parkinson's disease&#xD;
&#xD;
          -  Hoehn &amp; Yahr stage 2.5 or 3 patients&#xD;
&#xD;
          -  Patients with a Mini-Mental Status Examination (MMSE) score of 24 or higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe dyskinesia or on-off fluctuations due to medication&#xD;
&#xD;
          -  Patients who need to change drugs during the study period&#xD;
&#xD;
          -  Patients with sensory abnormalities of the lower limb&#xD;
&#xD;
          -  Patients with vestibular disease or paroxismal vertigo&#xD;
&#xD;
          -  Patients with other neurological or orthopedic disease involving legs, or severe&#xD;
             cardiovascular diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Han Gil Seo</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>Robot-assisted gait training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</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/NCT02993042
org study id: RAGT-GAP
nct id: NCT02993042
lead sponsor: 
Robot-assisted gait training can improve gait ability of patients with Parkinson's disease by
      repeating a normal gait pattern with high intensity. This study is a feasibility study to
      investigate whether robot-assisted gait training can be applied to improve walking autonomy
      in patients with Parkinson 's disease.
Parkinson's disease is a disease caused by dopamine deficiency in the striatum resulting from
      the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive
      neurodegenerative disease characterized by motor symptoms including gait disturbance and
      balance instability. In the early stages of Parkinson's disease, dysfunction of the
      sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles.
      Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and
      the automaticity of walking is reduced. Walking performance in a dual-task condition has been
      used to assess gait automaticity in patients with Parkinson's disease.

      Robot-assisted gait training is a method of rehabilitation that repeats normal gait patterns
      at high intensity. Recent meta-analysis has shown that robot-assisted gait training improved
      the recovery of independent gait after stroke compared with conventional rehabilitation
      therapy. On the other hand, robot-assisted gait training in Parkinson's disease has been
      reported to improve walking speed and walking endurance compared to conventional physical
      therapy, but is not superior to treadmill exercise of the same intensity. In addition, it has
      been reported that in patients with Parkinson's disease with balance impairment,
      robot-assisted gait training can improve balance disorder compared with physical therapy, and
      gait freezing has improved in some small-scale patients. However, studies on the
      effectiveness of robot-assisted gait training in Parkinson's disease are still lacking, and
      the mechanism of the effect has not been elucidated. In particular, the effect on gait
      automaticity, which is a characteristic of Parkinson 's disease, has not been studied.
      Therefore, this pilot study is aimed to investigate whether robot-assisted gait training can
      be applied to improve walking autonomy in patients with Parkinson's disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of dual-task interference: cognitive
time frame: at 4 weeks
description: (Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
measure: Percentage of dual-task interference: physical
time frame: at 4 weeks
description: (Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
measure: 10 meter walk test (sec): single, cognitive dual-task, physical dual-task
time frame: baseline, at 4 weeks, at 8 weeks
measure: Berg balance scale
time frame: baseline, at 4 weeks, at 8 weeks
measure: Korean version of the Falls Efficacy Scale-International
time frame: baseline, at 4 weeks, at 8 weeks
measure: Step length
time frame: baseline, at 4 weeks, at 8 weeks
description: Gait analysis using IMU sensors
measure: Step width
time frame: baseline, at 4 weeks, at 8 weeks
description: Gait analysis using IMU sensors
measure: Cadence
time frame: baseline, at 4 weeks, at 8 weeks
description: Gait analysis using IMU sensors
measure: Vertical displacement
time frame: baseline, at 4 weeks, at 8 weeks
description: Gait analysis using IMU sensors
measure: Percentage of dual-task interference: cognitive
time frame: baseline, at 8 weeks
description: (Cognitive dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
measure: Percentage of dual-task interference: physical
time frame: baseline, at 8 weeks
description: (Physical dual-task performance - Single-task performance) / Single-task performance during 10 meter walk test
arm group label: Robot-assisted gait training
arm group type: Experimental
description: Robot-assisted gait training using an exoskeletal robot (Walkbot_S; P&S Mechanics Co. Ltd., Seoul, Korea)
intervention type: Device
intervention name: Robot-assisted gait training
description: Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.
arm group label: Robot-assisted gait training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Han Gil Seo
investigator title: Clinical Assistant Professor
mesh term: Parkinson Disease
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic