NCT04419285

Mobility Protocol Adapted for Advanced Visually Impaired Subjects

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pigmentary Retinopathy

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2020-03-02
• Primary completion: 2024-06-02
• Completion: 2024-06-04
• First posted: 2020-06-05
• Last updated: 2020-06-05

Locations

1 site across 1 country: France