Mobility Protocol Adapted for Advanced Visually Impaired Subjects
NCT ID: NCT04419285
Last Updated: 2020-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-03-02
2024-06-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Retinitis Pigmentosa patients
50 patients with very severe Retinitis Pigmentosa
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.
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.
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
OTHER
Responsible Party
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Principal Investigators
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Saddek SM MOHAND-SAID, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Locations
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A00937-50
Identifier Type: OTHER
Identifier Source: secondary_id
P19-04
Identifier Type: -
Identifier Source: org_study_id
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