Mobility Protocol Adapted for Advanced Visually Impaired Subjects (PROMA)

June 3, 2020 updated by: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Retinitis Pigmentosa patients
50 patients with very severe Retinitis Pigmentosa
Behavioral: Locomotion task
The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
Other Names:
  • Streetlab platform
Behavioral: Posturology task SOT (Sensory Organization Test)
The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
Other Names:
  • Streetlab platform
  • Opal MobilityLab
Behavioral: The quality of life questionnaire
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.
Other Names:
  • NEI-VFQ-25
  • ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Discriminating
Time Frame: Month 1
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.
Month 1
Reproducibility
Time Frame: Month 1
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.
Month 1
Validity of construction
Time Frame: Month 1
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.
Month 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of postural parameters
Time Frame: Month 1

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.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saddek SM MOHAND-SAID, MD, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P19-04
  • 2019-A00937-50 (OTHER: IDRCB Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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