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Mobility Protocol Adapted for Advanced Visually Impaired Subjects (PROMA)

Primary Purpose

Pigmentary Retinopathy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Locomotion task
Posturology task SOT (Sensory Organization Test)
The quality of life questionnaire
Sponsored by
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pigmentary Retinopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist
  • ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen)
  • Doesn't participate in clinical research that may interfere with this study
  • Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received
  • Consent to the study signed after information by the investigator
  • Health insurance affiliation

Exclusion Criteria:

  • Pregnant women
  • Inability to give personal consent
  • Cataract surgery in the 3 months preceding inclusion
  • Amblyopia
  • Inability to comply with the instructions for carrying out the study tasks or to complete the study visits
  • MMSE score without visual item ≤ 20/25
  • Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations

Sites / Locations

  • Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Retinitis Pigmentosa patients

Arm Description

50 patients with very severe Retinitis Pigmentosa

Outcomes

Primary Outcome Measures

Discriminating
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.
Reproducibility
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.
Validity of construction
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.

Secondary Outcome Measures

Measurement of postural parameters
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.

Full Information

First Posted
May 7, 2020
Last Updated
June 3, 2020
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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1. Study Identification

Unique Protocol Identification Number
NCT04419285
Brief Title
Mobility Protocol Adapted for Advanced Visually Impaired Subjects
Acronym
PROMA
Official Title
Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
June 2, 2024 (Anticipated)
Study Completion Date
June 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmentary Retinopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retinitis Pigmentosa patients
Arm Type
Experimental
Arm Description
50 patients with very severe Retinitis Pigmentosa
Intervention Type
Behavioral
Intervention Name(s)
Locomotion task
Other Intervention Name(s)
Streetlab platform
Intervention Description
The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
Intervention Type
Behavioral
Intervention Name(s)
Posturology task SOT (Sensory Organization Test)
Other Intervention Name(s)
Streetlab platform, Opal MobilityLab
Intervention Description
The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
Intervention Type
Behavioral
Intervention Name(s)
The quality of life questionnaire
Other Intervention Name(s)
NEI-VFQ-25, ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)
Intervention 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.
Primary Outcome Measure Information:
Title
Discriminating
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.
Time Frame
Month 1
Title
Reproducibility
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.
Time Frame
Month 1
Title
Validity of construction
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.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Measurement of postural parameters
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.
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Retinitis Pigmentosa, non-syndromic, the diagnosis of which has been confirmed by an ophtmalmologist ETDRS visual acuity less than 2/10 (>+0.7 logMAR; <20/100 Snellen) Doesn't participate in clinical research that may interfere with this study Sufficient knowledge of the French language to ensure a perfect understanding of the tasks to be performed and the instructions received Consent to the study signed after information by the investigator Health insurance affiliation Exclusion Criteria: Pregnant women Inability to give personal consent Cataract surgery in the 3 months preceding inclusion Amblyopia Inability to comply with the instructions for carrying out the study tasks or to complete the study visits MMSE score without visual item ≤ 20/25 Drug treatment which can lead to motor, visual or cognitive disorders (PSA, neuroleptics,etc.) or which may interfere with the study's evaluations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania TR RILCY
Phone
+33140021126
Email
trilcy@15-20.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hayet HS SERHANE
Phone
+3314021144
Email
hserhane@15-20.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saddek SM MOHAND-SAID, MD
Organizational Affiliation
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saddek SM MOHAND-SAID, MD
Phone
01400021421
Email
smolhand@15-20.fr

12. IPD Sharing Statement

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Mobility Protocol Adapted for Advanced Visually Impaired Subjects

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