An interventional study of Locomotion task and Posturology task SOT (Sensory Organization Test) in Pigmentary Retinopathy, sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. Status unknown at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts · Not applicable, Interventional, and Other
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:
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.
268 studies on the registry are indexed under Retinitis Pigmentosa; 71 are open to participants now.
This study's planned enrollment of 50 is above the median of 27 across 173 interventional studies indexed under Retinitis Pigmentosa.
Browse Retinitis Pigmentosa studies →Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts is the lead sponsor of 28 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 patients with very severe Retinitis Pigmentosa
Behavioral: Locomotion task · Behavioral: Posturology task SOT (Sensory Organization Test) · Behavioral: The quality of life questionnaire
The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
Also known as: Streetlab platform
The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
Also known as: Streetlab platform, Opal MobilityLab
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.
Also known as: NEI-VFQ-25, ULV VFQ (Ultra Low Vision Visual Funnctioning Questionnaire)
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.
Time frame: Month 1
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.
Time frame: Month 1
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.
Time frame: Month 1
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.
Time frame: Month 1
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts