<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/NCT01684267</url>
  </required_header>
  <id_info>
    <org_study_id>2009-P-000447</org_study_id>
    <nct_id>NCT01684267</nct_id>
  </id_info>
  <brief_title>Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields</brief_title>
  <official_title>Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</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>
      To test the usability and effectiveness of a robotic device, called the Robotic Gait&#xD;
      Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2)&#xD;
      patients with stroke with gait abnormalities secondary to impaired knee function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The device is designed to train stroke patients to correct abnormal gait patterns associated&#xD;
      with exaggerated and uncoordinated movements of the pelvis by applying force fields to&#xD;
      correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e.&#xD;
      exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients.&#xD;
      The human-robot interface will be based on impedance control techniques so that the&#xD;
      force-field actuators generate smooth virtual spring/damper restitution forces at the&#xD;
      patient's pelvic area.&#xD;
&#xD;
      As part of the study we will determine whether the force fields applied by the actuated&#xD;
      components of the device can effect an acute change in gait biomechanics, primarily pelvis&#xD;
      motion during stance and swing phases, in healthy subjects and patients with stroke during&#xD;
      ambulation. The investigators will also evaluate the usability of the orthosis in terms of&#xD;
      donning &amp; doffing, user confidence, and comfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic obliquity</measure>
    <time_frame>1 day</time_frame>
    <description>Change in pelvic obliquity during gait consequent to force application</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Gait Re-training in Healthy Subjects</condition>
  <condition>Gait Re-training in Stroke Survivors</condition>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy individuals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-stroke</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic stroke survivors</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic Gait Rehabilitation (RGR) Trainer</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Post-stroke</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        HEALTHY&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Can walk comfortably on a treadmill&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or&#xD;
             gait disorder that results in an abnormal gait pattern&#xD;
&#xD;
          -  Females in the second or third trimester of pregnancy&#xD;
&#xD;
        STROKE&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the&#xD;
             lower extremity&#xD;
&#xD;
          -  residual deficits of gait&#xD;
&#xD;
          -  be able to ambulate without the use of assistive devices or assistance of a person&#xD;
&#xD;
          -  able to walk at a comfortable walking speed of ~0.6 m/s&#xD;
&#xD;
          -  able to walk safely on a treadmill&#xD;
&#xD;
          -  medically stable&#xD;
&#xD;
          -  No other neurological problems, or any known cardiovascular or musculoskeletal&#xD;
             disorders that effects their gait or excludes them from exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to attend and follow instructions&#xD;
&#xD;
          -  require physical assistance for ambulation&#xD;
&#xD;
          -  other known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or&#xD;
             gait disorder that results in an abnormal gait pattern&#xD;
&#xD;
          -  severe joint contractures of the hemi-paretic knee&#xD;
&#xD;
          -  females in the second or third trimester of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spaulding Rehabilitation Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Paolo Bonato</investigator_full_name>
    <investigator_title>Director, Motion Analysis Laboratory</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Gait</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684267
org study id: 2009-P-000447
nct id: NCT01684267
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To test the usability and effectiveness of a robotic device, called the Robotic Gait
      Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2)
      patients with stroke with gait abnormalities secondary to impaired knee function.
The device is designed to train stroke patients to correct abnormal gait patterns associated
      with exaggerated and uncoordinated movements of the pelvis by applying force fields to
      correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e.
      exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients.
      The human-robot interface will be based on impedance control techniques so that the
      force-field actuators generate smooth virtual spring/damper restitution forces at the
      patient's pelvic area.

      As part of the study we will determine whether the force fields applied by the actuated
      components of the device can effect an acute change in gait biomechanics, primarily pelvis
      motion during stance and swing phases, in healthy subjects and patients with stroke during
      ambulation. The investigators will also evaluate the usability of the orthosis in terms of
      donning & doffing, user confidence, and comfort.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pelvic obliquity
time frame: 1 day
description: Change in pelvic obliquity during gait consequent to force application
arm group label: Healthy
arm group type: Experimental
description: Healthy individuals
arm group label: Post-stroke
arm group type: Experimental
description: Chronic stroke survivors
intervention type: Device
intervention name: Robotic Gait Rehabilitation (RGR) Trainer
arm group label: Healthy
arm group label: Post-stroke
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Paolo Bonato
investigator title: Director, Motion Analysis Laboratory
mesh term: Stroke