<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/NCT03260738</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC17.0084</org_study_id>
    <nct_id>NCT03260738</nct_id>
  </id_info>
  <brief_title>Robot Coach of Chronic Low Back Pain Patient</brief_title>
  <acronym>RCOOL</acronym>
  <official_title>Preliminary Feasibility Study of Rehabilitation by Robot &quot;Coach&quot; of Chronic Low Back Pain Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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 objective of KERAAL technological project is to create a new intelligent robot which&#xD;
      allows a humanoid robot to record then to show and to follow the progress of rehabilitation&#xD;
      sessions proposed by a physiotherapist to a patient, the latter being able to practice&#xD;
      without the physiotherapist. The final objective is to stimulate and increase the overseen&#xD;
      time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements&#xD;
      notably movements of the spine with 5 degrees of freedom associated to the several levels of&#xD;
      the spine. It will allow to address the population included in the protocol. RCOOL study&#xD;
      tries to validate this prototype device as tool of rehabilitation.&#xD;
&#xD;
      The main objective is the feasibility of the supervision by a humanoid robot of a succession&#xD;
      of rehabilitation exercises.&#xD;
&#xD;
      RCOOL study is a randomized clinical trial checked under single-blind condition to compare&#xD;
      two rehabilitation strategies, one with exercises executed by the patients and supervised by&#xD;
      Poppy and the other one with usual rehabilitation protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">April 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 26, 2018</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>Device Feasibility</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average time of the daily physical activity</measure>
    <time_frame>Day 0 to Week 4</time_frame>
    <description>Each therapist note the time of each physical activity session with the usually breaks. The time of kinesitherapy included the activity supervised by poppy will allow to evaluate the prototype device feasibility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale (EVA) of lumbar pain</measure>
    <time_frame>Day 0, Week 4 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Roland-Morris questionnaire</measure>
    <time_frame>Day 0, Week 4 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dallas questionnaire</measure>
    <time_frame>Day 0, Week 4 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance and Belief Questionnaire (FABQ)</measure>
    <time_frame>Day 0, Week 4 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Day 0 to Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability questionnaire</measure>
    <time_frame>Week 4 and Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)</measure>
    <time_frame>Day 0 to Week 4</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>&quot;Robot Poppy&quot; group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes of daily rehabilitation program (physical exercises dedicated to the mobility of the spine) supervised by Poppy robot during 3 weeks included in a 3hours daily (5 days a week) rehabilitation program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rehabilitation program with Poppy robot</intervention_name>
    <description>Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy.</description>
    <arm_group_label>&quot;Robot Poppy&quot; group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual rehabilitation program</intervention_name>
    <description>Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Low back pain (more than 6 months)&#xD;
&#xD;
          -  Patient who has completed an outpatient rehabilitation program with at least 20&#xD;
             spine-centric sessions&#xD;
&#xD;
          -  Inclusion in a low back pain rehabilitation program in an inpatient our outpatient&#xD;
             unit.&#xD;
&#xD;
          -  Adult between 18 and 70 years old&#xD;
&#xD;
          -  Patient affiliated to French social security system&#xD;
&#xD;
          -  Patient having signed an informed consent of participation for research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic low back pain (identified medical etiology)&#xD;
&#xD;
          -  Isolated sciatica, whatever the cause&#xD;
&#xD;
          -  Cruralgia&#xD;
&#xD;
          -  Chronic widespread pain&#xD;
&#xD;
          -  Age lower than 18 and higher than 70&#xD;
&#xD;
          -  Unfit of agreeing or refusing to participate in the study&#xD;
&#xD;
          -  Unstable medical situation preventing the continuous realization of a program of at&#xD;
             least 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondation ILDYS - Service de MPR de l'appareil locomoteur de PERHARIDY</name>
      <address>
        <city>Roscoff</city>
        <zip>29680</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Low Back Pain</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Robot Poppy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</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/NCT03260738
org study id: 29BRC17.0084
nct id: NCT03260738
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of KERAAL technological project is to create a new intelligent robot which
      allows a humanoid robot to record then to show and to follow the progress of rehabilitation
      sessions proposed by a physiotherapist to a patient, the latter being able to practice
      without the physiotherapist. The final objective is to stimulate and increase the overseen
      time of rehabilitation. Poppy robot was chosen as it is able to realize all kind of movements
      notably movements of the spine with 5 degrees of freedom associated to the several levels of
      the spine. It will allow to address the population included in the protocol. RCOOL study
      tries to validate this prototype device as tool of rehabilitation.

      The main objective is the feasibility of the supervision by a humanoid robot of a succession
      of rehabilitation exercises.

      RCOOL study is a randomized clinical trial checked under single-blind condition to compare
      two rehabilitation strategies, one with exercises executed by the patients and supervised by
      Poppy and the other one with usual rehabilitation protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Single (Outcomes Assessor)
measure: Average time of the daily physical activity
time frame: Day 0 to Week 4
description: Each therapist note the time of each physical activity session with the usually breaks. The time of kinesitherapy included the activity supervised by poppy will allow to evaluate the prototype device feasibility.
measure: Visual Analog Scale (EVA) of lumbar pain
time frame: Day 0, Week 4 and Month 6
measure: Roland-Morris questionnaire
time frame: Day 0, Week 4 and Month 6
measure: Dallas questionnaire
time frame: Day 0, Week 4 and Month 6
measure: Fear Avoidance and Belief Questionnaire (FABQ)
time frame: Day 0, Week 4 and Month 6
measure: Number of adverse events
time frame: Day 0 to Day 90
measure: Acceptability questionnaire
time frame: Week 4 and Month 6
measure: Number of exercises done during rehabilitation supervised by robot Poppy (30 minutes each day for 4 weeks)
time frame: Day 0 to Week 4
arm group label: "Robot Poppy" group
arm group type: Experimental
description: 30 minutes of daily rehabilitation program (physical exercises dedicated to the mobility of the spine) supervised by Poppy robot during 3 weeks included in a 3hours daily (5 days a week) rehabilitation program.
arm group label: Control group
arm group type: Active Comparator
description: Usual 3hours daily (5 days a week) rehabilitation program without robot during 3 weeks
intervention type: Device
intervention name: Rehabilitation program with Poppy robot
description: Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy.
arm group label: "Robot Poppy" group
intervention type: Other
intervention name: Usual rehabilitation program
description: Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain