xml: <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/NCT05988905</url>
    </required_header>
    <id_info>
      <org_study_id>HangangSHH-17</org_study_id>
      <nct_id>NCT05988905</nct_id>
    </id_info>
    <brief_title>The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury</brief_title>
    <official_title>The Effects of Gait Performance and Brain Activity After Robot-assisted Gait Training (RAGT) On Patients With Lower Extremity Thermal Injury : a Prospective, Randomized, Single-blinded Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hangang Sacred Heart Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hangang Sacred Heart 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>
        Gait enables individuals to move forward and is considered a natural skill. Gait disturbances&#xD;
        are very common in patients with burn injury. Major causes of gait disturbances are pain and&#xD;
        joint contractures. Recent studies focused on the application of robot-assisted gait training&#xD;
        (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and&#xD;
        investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.&#xD;
        To investigate the clinical effects, the investigators compare the results of RAGT group to&#xD;
        the results of matched conventional (CON) rehabilitation group.This single-blinded,&#xD;
        randomized, controlled trial involved 40 patients with lower extremity burns. Patients were&#xD;
        randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a&#xD;
        footplate that assists patients to perform gait motions. RAGT enables training of&#xD;
        automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR®&#xD;
        and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8&#xD;
        weeks. The CON group focused on gait training such as active range of motion (ROM) exercise,&#xD;
        weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min&#xD;
        once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy&#xD;
        (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical&#xD;
        activity has not previously been documented in patients with burn injury. The primary outcome&#xD;
        was the prefrontal cortical activity in the both groups. The walking-related cortical&#xD;
        activity using an fNIRS device before and after 8 weeks training were measured. To evaluate&#xD;
        functional recovery, functional ambulation category (FAC) scores and 6-minute walking test&#xD;
        (6MWT) distances were measured. Numeric rating scale (NRS) was used to rate the degree of&#xD;
        subjective pain during gait movement: 0 points were assigned when no pain was noted, and&#xD;
        unbearable pain was assigned 10 points.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gait enables individuals to move forward and is considered a natural skill. Gait disturbances&#xD;
        are very common in patients with burn injury. Major causes of gait disturbances are pain and&#xD;
        joint contractures. Recent studies focused on the application of robot-assisted gait training&#xD;
        (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and&#xD;
        investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.&#xD;
        To investigate the clinical effects, the investigators compare the results of RAGT group to&#xD;
        the results of matched conventional (CON) rehabilitation group.This single-blinded,&#xD;
        randomized, controlled trial involved 40 patients with lower extremity burns. Patients were&#xD;
        randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a&#xD;
        footplate that assists patients to perform gait motions. RAGT enables training of&#xD;
        automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR®&#xD;
        and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8&#xD;
        weeks. The CON group focused on gait training such as active range of motion (ROM) exercise,&#xD;
        weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min&#xD;
        once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy&#xD;
        (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical&#xD;
        activity has not previously been documented in patients with burn injury. The primary outcome&#xD;
        was the prefrontal cortical activity in the both groups. The walking-related cortical&#xD;
        activity using an fNIRS device before and after 8 weeks training were measured. To evaluate&#xD;
        functional recovery, functional ambulation category (FAC) scores and 6-minute walking test&#xD;
        (6MWT) distances were measured. Numeric rating scale (NRS) was used to rate the degree of&#xD;
        subjective pain during gait movement: 0 points were assigned when no pain was noted, and&#xD;
        unbearable pain was assigned 10 points.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>
      <intervention_model_description>robot assisted gait training</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Robot assisted gait training enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>near infrared spectroscopy</measure>
      <time_frame>8 weeks</time_frame>
      <description>The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>numeric rating scale (NRS)</measure>
      <time_frame>8 weeks</time_frame>
      <description>rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>functional ambulatory category</measure>
      <time_frame>8 weeks</time_frame>
      <description>FAC was evaluated based on six scales. Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6 minutes walking test</measure>
      <time_frame>8 weeks</time_frame>
      <description>Patients were instructed to walk as far as possible in 6 min</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gait Disorder, Sensorimotor</condition>
    <arm_group>
      <arm_group_label>robot assisted gait training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventioanl training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The conventional training group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>robot assited gati training</intervention_name>
      <description>SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists gait movements. The patient's thigh length and lower leg length were measured before training, so that the SUBAR® can be adjusted to patient's size to ensure accurate training. During training, the therapist facilitated the treatment and stood by the patients' side to adjust the direction and speed. RAGT is programmed automatically, and it can be performed regularly over a long period. The patients received 30 min of robot-assisted training using SUBAR® once a day for 5 days a week for 8 weeks. Each training session lasted up to 40 min.</description>
      <arm_group_label>robot assisted gait training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional traiing</intervention_name>
      <description>Patients also received conventional exercise rehabilitation with the same duration and frequency. Conventional rehabilitation therapy, which consisted of active assistive knee exercises, knee stretching, patellar mobilization exercises, and quadriceps setting exercises, was performed every day throughout the rehabilitation period.</description>
      <arm_group_label>conventioanl training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with full or virtually full thickness involvement of &gt;50% on the body surface&#xD;
               area of the bilateral lower extremity&#xD;
  &#xD;
            -  age &gt; 18 years&#xD;
  &#xD;
            -  with ≤1 functional ambulation category (FAC) score ≤ 3&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with cognitive disorders&#xD;
  &#xD;
            -  intellectual impairment before burn injury&#xD;
  &#xD;
            -  serious cardiac dysfunction&#xD;
  &#xD;
            -  problems with weight bearing due to unstable fractures&#xD;
  &#xD;
            -  body weight ≥100 kg&#xD;
  &#xD;
            -  severe fixed contracture&#xD;
  &#xD;
            -  skin disorders that could be worsened by RAGT and conventional rehabilitation&#xD;
  &#xD;
            -  patients with severe pain who were unable to undergo conventional rehabilitation&#xD;
               programs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>SO YOUNG JOO, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>handgang sacred heart hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sung Rakyum</last_name>
      <phone>82-2-2639-5900</phone>
      <email>sung6652@hallym.or.kr</email>
    </overall_contact>
    <results_reference>
      <citation>Knaepen K, Mierau A, Swinnen E, Fernandez Tellez H, Michielsen M, Kerckhofs E, Lefeber D, Meeusen R. Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking? PLoS One. 2015 Oct 20;10(10):e0140626. doi: 10.1371/journal.pone.0140626. eCollection 2015.</citation>
      <PMID>26485148</PMID>
    </results_reference>
    <results_reference>
      <citation>Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.</citation>
      <PMID>29604488</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hangang Sacred Heart Hospital</investigator_affiliation>
      <investigator_full_name>So Young Joo</investigator_full_name>
      <investigator_title>Hangang Sacred Heart Hospital</investigator_title>
    </responsible_party>
    <keyword>robot</keyword>
    <keyword>burn patient</keyword>
    <keyword>functional near-infrared spectroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gait Disorders, Neurologic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988905
  org study id: HangangSHH-17
  nct id: NCT05988905
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Gait enables individuals to move forward and is considered a natural skill. Gait disturbances
        are very common in patients with burn injury. Major causes of gait disturbances are pain and
        joint contractures. Recent studies focused on the application of robot-assisted gait training
        (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and
        investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.
        To investigate the clinical effects, the investigators compare the results of RAGT group to
        the results of matched conventional (CON) rehabilitation group.This single-blinded,
        randomized, controlled trial involved 40 patients with lower extremity burns. Patients were
        randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a
        footplate that assists patients to perform gait motions. RAGT enables training of
        automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR®
        and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8
        weeks. The CON group focused on gait training such as active range of motion (ROM) exercise,
        weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min
        once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy
        (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical
        activity has not previously been documented in patients with burn injury. The primary outcome
        was the prefrontal cortical activity in the both groups. The walking-related cortical
        activity using an fNIRS device before and after 8 weeks training were measured. To evaluate
        functional recovery, functional ambulation category (FAC) scores and 6-minute walking test
        (6MWT) distances were measured. Numeric rating scale (NRS) was used to rate the degree of
        subjective pain during gait movement: 0 points were assigned when no pain was noted, and
        unbearable pain was assigned 10 points.
  Gait enables individuals to move forward and is considered a natural skill. Gait disturbances
        are very common in patients with burn injury. Major causes of gait disturbances are pain and
        joint contractures. Recent studies focused on the application of robot-assisted gait training
        (RAGT) for improving gait functions. This study aimed to elucidate the efficacy and
        investigate the mechanism of motor recovery after RAGT on patients with lower extremity burn.
        To investigate the clinical effects, the investigators compare the results of RAGT group to
        the results of matched conventional (CON) rehabilitation group.This single-blinded,
        randomized, controlled trial involved 40 patients with lower extremity burns. Patients were
        randomized into a RAGT or a CON group. SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a
        footplate that assists patients to perform gait motions. RAGT enables training of
        automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR®
        and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8
        weeks. The CON group focused on gait training such as active range of motion (ROM) exercise,
        weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min
        once a day for 5 days a week for 8 weeks.A wearable functional near-infrared spectroscopy
        (fNIRS) device has been developed for studying cortical hemodynamics. Changes in cortical
        activity has not previously been documented in patients with burn injury. The primary outcome
        was the prefrontal cortical activity in the both groups. The walking-related cortical
        activity using an fNIRS device before and after 8 weeks training were measured. To evaluate
        functional recovery, functional ambulation category (FAC) scores and 6-minute walking test
        (6MWT) distances were measured. Numeric rating scale (NRS) was used to rate the degree of
        subjective pain during gait movement: 0 points were assigned when no pain was noted, and
        unbearable pain was assigned 10 points.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: robot assisted gait training
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Robot assisted gait training enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks. The CON group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.
  measure: near infrared spectroscopy
  time frame: 8 weeks
  description: The rest period before gait period served as a baseline reference for osyhemoglobin of PFC perfusion. Cortical activity was measured by evaluating relative changes in oxyhemoglobin level and deoxyhemoglobin level.
  measure: numeric rating scale (NRS)
  time frame: 8 weeks
  description: rate the degree of subjective pain during gait movement: 0 points were assigned when no pain was noted, and unbearable pain was assigned 10 points.
  measure: functional ambulatory category
  time frame: 8 weeks
  description: FAC was evaluated based on six scales. Scale 0 means that the patient cannot walk or can only walk with assistance of two people. Scale 5 means that the patient can walk independently.
  measure: 6 minutes walking test
  time frame: 8 weeks
  description: Patients were instructed to walk as far as possible in 6 min
  arm group label: robot assisted gait training
  arm group type: Experimental
  description: RAGT enables training of automatically programmed normal gait pattern. Patients underwent 30 min of RAGT using SUBAR® and conventional exercise rehabilitation each for 30 min once a day for 5 days a week for 8 weeks.
  arm group label: conventioanl training
  arm group type: Active Comparator
  description: The conventional training group focused on gait training such as active range of motion (ROM) exercise, weight bearing training, manual lymphatic drainage, and hypertrophic scar care for 60 min once a day for 5 days a week for 8 weeks.
  intervention type: Other
  intervention name: robot assited gati training
  description: SUBAR® (CRETEM, Korea) is a exoskeletal-robot with a footplate that assists gait movements. The patient's thigh length and lower leg length were measured before training, so that the SUBAR® can be adjusted to patient's size to ensure accurate training. During training, the therapist facilitated the treatment and stood by the patients' side to adjust the direction and speed. RAGT is programmed automatically, and it can be performed regularly over a long period. The patients received 30 min of robot-assisted training using SUBAR® once a day for 5 days a week for 8 weeks. Each training session lasted up to 40 min.
  arm group label: robot assisted gait training
  intervention type: Other
  intervention name: conventional traiing
  description: Patients also received conventional exercise rehabilitation with the same duration and frequency. Conventional rehabilitation therapy, which consisted of active assistive knee exercises, knee stretching, patellar mobilization exercises, and quadriceps setting exercises, was performed every day throughout the rehabilitation period.
  arm group label: conventioanl training
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: SO YOUNG JOO, MD
  role: Principal Investigator
  affiliation: handgang sacred heart hospital
  last name: Sung Rakyum
  phone: 82-2-2639-5900
  email: sung6652@hallym.or.kr
  citation: Knaepen K, Mierau A, Swinnen E, Fernandez Tellez H, Michielsen M, Kerckhofs E, Lefeber D, Meeusen R. Human-Robot Interaction: Does Robotic Guidance Force Affect Gait-Related Brain Dynamics during Robot-Assisted Treadmill Walking? PLoS One. 2015 Oct 20;10(10):e0140626. doi: 10.1371/journal.pone.0140626. eCollection 2015.
  PMID: 26485148
  citation: Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.
  PMID: 29604488
  responsible party type: Principal Investigator
  investigator affiliation: Hangang Sacred Heart Hospital
  investigator full name: So Young Joo
  investigator title: Hangang Sacred Heart Hospital
  mesh term: Gait Disorders, Neurologic
  sharing ipd: No