<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/NCT04460833</url>
  </required_header>
  <id_info>
    <org_study_id>BestOf_ARRoW Feedback</org_study_id>
    <nct_id>NCT04460833</nct_id>
  </id_info>
  <brief_title>Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy</brief_title>
  <acronym>BestOf_ARRoW</acronym>
  <official_title>Feedback in Augmented Reality to Control the Gait Parameters in Children With Cerebral Palsy (BestOf_ARRoW)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ellen Poidatz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Université Paris-Sud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondation Ellen Poidatz</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>
      Cerebral palsy (CP) describes a group of permanent disorders of the development of movement&#xD;
      and posture, causing activity limitation, that are attributed to non progressive disturbances&#xD;
      that occurred in the developing fetal or infant brain. The motor disorder of CP are often&#xD;
      accompanied by disturbances of sensation, perception, cognition, communication, and&#xD;
      behaviour; by epilepsy, and by secondary musculoskeletal problems.&#xD;
&#xD;
      Motor activities, especially walking, can be affected by many factors including sensory&#xD;
      deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide&#xD;
      feedback, during gait rehabilitation is a complementary approach to improve motor learning&#xD;
      during the rehabilitation protocol. However, the feedback modalities are multiple and no&#xD;
      study has compared these modalities. This study aims to test which feedback modalities could&#xD;
      control the gait parameters (speed, cadence, step length) of the child with CP in real-time,&#xD;
      through an augmented reality environment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">November 26, 2021</completion_date>
  <primary_completion_date type="Actual">July 7, 2020</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Feedback modalities are given through an augmented reality headset by random</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>1 year</time_frame>
    <description>Walking speed recorded with the augmented reality headset in real-time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>step length</measure>
    <time_frame>1 year</time_frame>
    <description>step length recorded with the augmented reality headset in real-time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moizer Questionary</measure>
    <time_frame>1 year</time_frame>
    <description>User experience survey; 25 items scored 1 for &quot;I perfectly agree&quot; to 5 &quot;I completly disagree&quot; this item; max score = 25; min score = 125</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Cerebral Palsy</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <condition>Feedback, Psychological</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All children will have the 6 feedback modalities + the control given randomly</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Feedback modalities given through an augmented reality headset</intervention_name>
    <description>All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with Cerebral palsy (medical file)&#xD;
&#xD;
          -  Age 12-18&#xD;
&#xD;
          -  Global Motor Function Classification System (GMFCS) I-III&#xD;
&#xD;
          -  Functional Mobility Scale (FMS) minimum 2 for &quot;50 meters&quot;&#xD;
&#xD;
          -  Ability to cooperate, to understand and to follow instructions&#xD;
&#xD;
          -  Patient affiliated to the French social security system&#xD;
&#xD;
          -  Patient volunteers whose the parents given their authorization to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical decision for any reason&#xD;
&#xD;
          -  Child or parent decision for any reason&#xD;
&#xD;
          -  Inability to cooperate, to understand and to follow instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric DESAILLY, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondation Ellen Poidatz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondation Ellen Poidatz</name>
      <address>
        <city>Saint-Fargeau-Ponthierry</city>
        <state>ILE DE France</state>
        <zip>77310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.fondationpoidatz.com/</url>
    <description>Website of the EllenPoidatz Foundation (See Research and Innovation)</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 22, 2022</last_update_submitted>
  <last_update_submitted_qc>June 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Serious Game</keyword>
  <keyword>Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <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>


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/NCT04460833
org study id: BestOf_ARRoW Feedback
nct id: NCT04460833
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cerebral palsy (CP) describes a group of permanent disorders of the development of movement
      and posture, causing activity limitation, that are attributed to non progressive disturbances
      that occurred in the developing fetal or infant brain. The motor disorder of CP are often
      accompanied by disturbances of sensation, perception, cognition, communication, and
      behaviour; by epilepsy, and by secondary musculoskeletal problems.

      Motor activities, especially walking, can be affected by many factors including sensory
      deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide
      feedback, during gait rehabilitation is a complementary approach to improve motor learning
      during the rehabilitation protocol. However, the feedback modalities are multiple and no
      study has compared these modalities. This study aims to test which feedback modalities could
      control the gait parameters (speed, cadence, step length) of the child with CP in real-time,
      through an augmented reality environment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
masking description: Feedback modalities are given through an augmented reality headset by random
measure: walking speed
time frame: 1 year
description: Walking speed recorded with the augmented reality headset in real-time
measure: step length
time frame: 1 year
description: step length recorded with the augmented reality headset in real-time
measure: Moizer Questionary
time frame: 1 year
description: User experience survey; 25 items scored 1 for "I perfectly agree" to 5 "I completly disagree" this item; max score = 25; min score = 125
arm group label: Test group
arm group type: Experimental
description: All children will have the 6 feedback modalities + the control given randomly
intervention type: Device
intervention name: Feedback modalities given through an augmented reality headset
description: All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.
arm group label: Test group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Eric DESAILLY, PhD
role: Principal Investigator
affiliation: Fondation Ellen Poidatz
facility: 
country: France
url: https://www.fondationpoidatz.com/
description: Website of the EllenPoidatz Foundation (See Research and Innovation)
responsible party type: Sponsor
mesh term: Cerebral Palsy
mesh term: Nervous System Diseases
mesh term: Gait Disorders, Neurologic
sharing ipd: No