<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/NCT03828110</url>
  </required_header>
  <id_info>
    <org_study_id>GIP-454</org_study_id>
    <nct_id>NCT03828110</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Robotic Gait Training in Children With Neurological Impairment</brief_title>
  <official_title>Investigating the Effectiveness of Robotic-Assisted Gait Training (RAGT) in the Rehabilitation of Children With Neurological Impairment Due to Acquired Brain Injury or Cerebral Palsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Eugenio Medea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Eugenio Medea</source>
  <oversight_info>
    <has_dmc>No</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>
      The recovery of walking ability is one of the primary rehabilitation goals for children with&#xD;
      neurological impairment. The aim of the study is to investigate the clinical effectiveness of&#xD;
      rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of&#xD;
      the research are to identify the specific effects of RAGT in children with different&#xD;
      etiologies (acquired brain injury and cerebral palsy) and with different levels of function&#xD;
      (according to the Gross Motor Function Classification System).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 6minWT distance walked</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in GMFM-88: total score and Dimensions</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in spatiotemporal gait parameters</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Data obtained using 3D gait analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in kinematic gait parameters</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Data obtained using 3D gait analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in kinetic gait parameters</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Data obtained using 3D gait analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in FAQ score</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lokomat therapy duration</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Total duration of therapy sessions (hours and minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lokomat therapy total distance walked</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Total distance walked during sessions (in meters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lokomat therapy total time walked</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Total time walked during sessions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lokomat stiffness values (LStiff)</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Joint stiffness measured by the Lokomat device (in Newton/meters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lokomat force values (LForce)</measure>
    <time_frame>After four weeks of treatment</time_frame>
    <description>Joint force measured by the Lokomat device (in Newton)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Acquired Brain Injury</condition>
  <condition>Cerebral Palsy</condition>
  <arm_group>
    <arm_group_label>Children with neurological impairment</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic Assisted Gait Training (Lokomat)</intervention_name>
    <description>The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.</description>
    <arm_group_label>Children with neurological impairment</arm_group_label>
    <other_name>RAGT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>The physiotherapic sessions aimed at strengthening the gluteus and quadriceps muscles, stretching the hip flexor and hamstrings muscles, increasing static balance, increasing dynamic balance, increasing functional abilities, improving ground gait and climbing stairs.</description>
    <arm_group_label>Children with neurological impairment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Neurophysiatric care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of acquired brain injury in pediatric age and adolescence (4 to 18 years) or&#xD;
             cerebral palsy;&#xD;
&#xD;
          -  Femur length of at least 23 cm;&#xD;
&#xD;
          -  Patients able to signal pain, fear or discomfort reliably and to follow simple&#xD;
             instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  injection of botulinum toxin during the 6 months prior to the enrollment;&#xD;
&#xD;
          -  oral medications reducing muscle tone;&#xD;
&#xD;
          -  previous orthopedic surgery;&#xD;
&#xD;
          -  severe lower-extremity contractures;&#xD;
&#xD;
          -  fractures or osseous instabilities;&#xD;
&#xD;
          -  osteoporosis;&#xD;
&#xD;
          -  contraindication of full body load due to previous surgeries;&#xD;
&#xD;
          -  severe retarded bone growth;&#xD;
&#xD;
          -  unhealed skin lesions in the lower-extremities;&#xD;
&#xD;
          -  thromboembolic diseases&#xD;
&#xD;
          -  cardiovascular instability&#xD;
&#xD;
          -  acute or progressive neurological disorders&#xD;
&#xD;
          -  aggressive or self-harming behavior.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emilia Biffi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scientific Institute IRCCS &quot;E. Medea&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scientific Institute IRCCS E. Medea</name>
      <address>
        <city>Bosisio Parini</city>
        <state>Lecco</state>
        <zip>23842</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Robotic-Assisted Gait Training</keyword>
  <keyword>Gait Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Cerebral Palsy</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/NCT03828110
org study id: GIP-454
nct id: NCT03828110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The recovery of walking ability is one of the primary rehabilitation goals for children with
      neurological impairment. The aim of the study is to investigate the clinical effectiveness of
      rehabilitation treatments based of Robotic-Assisted Gait Training (RAGT). Additional goals of
      the research are to identify the specific effects of RAGT in children with different
      etiologies (acquired brain injury and cerebral palsy) and with different levels of function
      (according to the Gross Motor Function Classification System).
observational model: Cohort
time perspective: Retrospective
measure: Change in 6minWT distance walked
time frame: After four weeks of treatment
description: The 6-minute walk test (6minWT) was used to assess endurance during self-paced, submaximal walk by measuring the distance walked within 6 minutes along a standardized route through the hospital corridors.
measure: change in GMFM-88: total score and Dimensions
time frame: After four weeks of treatment
description: The Gross Motor Function Measure (GMFM) measures the child's overall functional abilities, and is divided into the following sections: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping.
measure: change in spatiotemporal gait parameters
time frame: After four weeks of treatment
description: Data obtained using 3D gait analysis
measure: change in kinematic gait parameters
time frame: After four weeks of treatment
description: Data obtained using 3D gait analysis
measure: change in kinetic gait parameters
time frame: After four weeks of treatment
description: Data obtained using 3D gait analysis
measure: change in FAQ score
time frame: After four weeks of treatment
description: The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living
measure: Lokomat therapy duration
time frame: After four weeks of treatment
description: Total duration of therapy sessions (hours and minutes)
measure: Lokomat therapy total distance walked
time frame: After four weeks of treatment
description: Total distance walked during sessions (in meters)
measure: Lokomat therapy total time walked
time frame: After four weeks of treatment
description: Total time walked during sessions
measure: Lokomat stiffness values (LStiff)
time frame: After four weeks of treatment
description: Joint stiffness measured by the Lokomat device (in Newton/meters)
measure: Lokomat force values (LForce)
time frame: After four weeks of treatment
description: Joint force measured by the Lokomat device (in Newton)
arm group label: Children with neurological impairment
intervention type: Device
intervention name: Robotic Assisted Gait Training (Lokomat)
description: The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.
arm group label: Children with neurological impairment
other name: RAGT
intervention type: Procedure
intervention name: Physiotherapy
description: The physiotherapic sessions aimed at strengthening the gluteus and quadriceps muscles, stretching the hip flexor and hamstrings muscles, increasing static balance, increasing dynamic balance, increasing functional abilities, improving ground gait and climbing stairs.
arm group label: Children with neurological impairment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Emilia Biffi, PhD
role: Principal Investigator
affiliation: Scientific Institute IRCCS "E. Medea"
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Cerebral Palsy