<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/NCT04419285</url>
  </required_header>
  <id_info>
    <org_study_id>P19-04</org_study_id>
    <secondary_id>2019-A00937-50</secondary_id>
    <nct_id>NCT04419285</nct_id>
  </id_info>
  <brief_title>Mobility Protocol Adapted for Advanced Visually Impaired Subjects</brief_title>
  <acronym>PROMA</acronym>
  <official_title>Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</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>
      Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors,&#xD;
      responsible for a progressive and severe loss of vision.&#xD;
&#xD;
      People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life,&#xD;
      specifically for:&#xD;
&#xD;
        -  Visual research&#xD;
&#xD;
        -  Visuo-motor coordination in tasks requiring fine motor control&#xD;
&#xD;
        -  Visuo-motor coordination in mobility tasks&#xD;
&#xD;
      This study aims to assess the difficulties in the daily life of subjects with Retinitis&#xD;
      Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified&#xD;
      locomotion tasks in real situation and a posture task.&#xD;
&#xD;
      They are proposing a new test adapted and carried out in real situations, in binocular and&#xD;
      monocular vision, making it possible to finely assess locomotion especially for &quot;very low&#xD;
      vision&quot; patients.&#xD;
&#xD;
      This test will also ultimately make it possible to better evaluate the effectivements, that&#xD;
      is to say to observe and quantify objectively by a score the performance progression obtained&#xD;
      for locomotion tasks related to the visual recovery generated by the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is monocentric study and the total duration of the study is 48 months. The duration of&#xD;
      participation for each research subject is 3 months and maximum 4 visits. This is research&#xD;
      involving the human type of non-invasive interventional research, with minimal risks and&#xD;
      constraints.&#xD;
&#xD;
      This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at&#xD;
      a very advanced stage.&#xD;
&#xD;
      There will be an inclusion visit including a visual assessment and an ophthalmological&#xD;
      consultation. Two experimental visits with tests carried out in a real environment including&#xD;
      a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following&#xD;
      the second experimental visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Anticipated">June 4, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2, 2024</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>
    <intervention_model_description>The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Discriminating</measure>
    <time_frame>Month 1</time_frame>
    <description>Study of the correlation between the severity of the impairment with regard to visual evaluations (visual acuity, visual field, ect) and the performance score for locomotion and posture tests.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproducibility</measure>
    <time_frame>Month 1</time_frame>
    <description>Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validity of construction</measure>
    <time_frame>Month 1</time_frame>
    <description>Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of postural parameters</measure>
    <time_frame>Month 1</time_frame>
    <description>The locomotion task which takes place in a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns. For the other tests, the number of turns and the distance to be covered are identical, but the shapes of the courses are systematically different.&#xD;
The posturology task SOT (Sensory Organization Test) takes place in a StreetLab platform with uniform walls without decorations so as to remove any localization element.&#xD;
The subject is instructed to stand with his hands on his hips as steadily as possible. This test includes 4 experimental conditions for disturbing sensory inputs. the duration of acquisition is 30 seconds, during which the subject must hold a standing position as tatic as possible, without speaking, els hands positioned on the hips while looking straight ahead. Four experimental conditions are tested: Eyes open on a hard floor, eyes closed on a hard floor, eyes open on a foam tray, eyes closed on a foam tray.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pigmentary Retinopathy</condition>
  <arm_group>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 patients with very severe Retinitis Pigmentosa</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Locomotion task</intervention_name>
    <description>The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.</description>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <other_name>Streetlab platform</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Posturology task SOT (Sensory Organization Test)</intervention_name>
    <description>The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.</description>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <other_name>Streetlab platform</other_name>
    <other_name>Opal MobilityLab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The quality of life questionnaire</intervention_name>
    <description>Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance.</description>
    <arm_group_label>Retinitis Pigmentosa patients</arm_group_label>
    <other_name>NEI-VFQ-25</other_name>
    <other_name>ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an&#xD;
             ophtmalmologist&#xD;
&#xD;
          -  ETDRS visual acuity less than 2/10 (&gt;+0.7 logMAR; &lt;20/100 Snellen)&#xD;
&#xD;
          -  Doesn't participate in clinical research that may interfere with this study&#xD;
&#xD;
          -  Sufficient knowledge of the French language to ensure a perfect understanding of the&#xD;
             tasks to be performed and the instructions received&#xD;
&#xD;
          -  Consent to the study signed after information by the investigator&#xD;
&#xD;
          -  Health insurance affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Inability to give personal consent&#xD;
&#xD;
          -  Cataract surgery in the 3 months preceding inclusion&#xD;
&#xD;
          -  Amblyopia&#xD;
&#xD;
          -  Inability to comply with the instructions for carrying out the study tasks or to&#xD;
             complete the study visits&#xD;
&#xD;
          -  MMSE score without visual item ≤ 20/25&#xD;
&#xD;
          -  Drug treatment which can lead to motor, visual or cognitive disorders (PSA,&#xD;
             neuroleptics,etc.) or which may interfere with the study's evaluations&#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>Saddek SM MOHAND-SAID, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tania TR RILCY</last_name>
    <phone>+33140021126</phone>
    <email>trilcy@15-20.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hayet HS SERHANE</last_name>
    <phone>+3314021144</phone>
    <email>hserhane@15-20.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Saddek SM MOHAND-SAID, MD</last_name>
      <phone>01400021421</phone>
      <email>smolhand@15-20.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinitis Pigmentosa</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/NCT04419285
org study id: P19-04
secondary id: 2019-A00937-50
nct id: NCT04419285
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors,
      responsible for a progressive and severe loss of vision.

      People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life,
      specifically for:

        -  Visual research

        -  Visuo-motor coordination in tasks requiring fine motor control

        -  Visuo-motor coordination in mobility tasks

      This study aims to assess the difficulties in the daily life of subjects with Retinitis
      Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified
      locomotion tasks in real situation and a posture task.

      They are proposing a new test adapted and carried out in real situations, in binocular and
      monocular vision, making it possible to finely assess locomotion especially for "very low
      vision" patients.

      This test will also ultimately make it possible to better evaluate the effectivements, that
      is to say to observe and quantify objectively by a score the performance progression obtained
      for locomotion tasks related to the visual recovery generated by the treatment.
This is monocentric study and the total duration of the study is 48 months. The duration of
      participation for each research subject is 3 months and maximum 4 visits. This is research
      involving the human type of non-invasive interventional research, with minimal risks and
      constraints.

      This exploratory study will be conducted on a group of patients with Retinitis Pigmentosa at
      a very advanced stage.

      There will be an inclusion visit including a visual assessment and an ophthalmological
      consultation. Two experimental visits with tests carried out in a real environment including
      a locomotion and a posture tasks. An end-of-study visit within a maximum of 1 month following
      the second experimental visit.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages
primary purpose: Other
masking: None (Open Label)
measure: Discriminating
time frame: Month 1
description: Study of the correlation between the severity of the impairment with regard to visual evaluations (visual acuity, visual field, ect) and the performance score for locomotion and posture tests.
measure: Reproducibility
time frame: Month 1
description: Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
measure: Validity of construction
time frame: Month 1
description: Graphical and tabular representations will be prepared to represent the correlation between test results and visual function measures on the one hand and daily life activities on the other.
measure: Measurement of postural parameters
time frame: Month 1
description: The locomotion task which takes place in a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns. For the other tests, the number of turns and the distance to be covered are identical, but the shapes of the courses are systematically different.
The posturology task SOT (Sensory Organization Test) takes place in a StreetLab platform with uniform walls without decorations so as to remove any localization element.
The subject is instructed to stand with his hands on his hips as steadily as possible. This test includes 4 experimental conditions for disturbing sensory inputs. the duration of acquisition is 30 seconds, during which the subject must hold a standing position as tatic as possible, without speaking, els hands positioned on the hips while looking straight ahead. Four experimental conditions are tested: Eyes open on a hard floor, eyes closed on a hard floor, eyes open on a foam tray, eyes closed on a foam tray.
arm group label: Retinitis Pigmentosa patients
arm group type: Experimental
description: 50 patients with very severe Retinitis Pigmentosa
intervention type: Behavioral
intervention name: Locomotion task
description: The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
arm group label: Retinitis Pigmentosa patients
other name: Streetlab platform
intervention type: Behavioral
intervention name: Posturology task SOT (Sensory Organization Test)
description: The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
arm group label: Retinitis Pigmentosa patients
other name: Streetlab platform
other name: Opal MobilityLab
intervention type: Behavioral
intervention name: The quality of life questionnaire
description: Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance.
arm group label: Retinitis Pigmentosa patients
other name: NEI-VFQ-25
other name: ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Saddek SM MOHAND-SAID, MD
role: Principal Investigator
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
last name: Tania TR RILCY
phone: +33140021126
email: trilcy@15-20.fr
last name: Hayet HS SERHANE
phone: +3314021144
email: hserhane@15-20.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Retinitis Pigmentosa