Mobility Protocol Adapted for Advanced Visually Impaired Subjects

Pigmentary Retinopathy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419285
• Other study ID #: P19-04
• Secondary ID: 2019-A00937-50
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: June 4, 2024

Study information

• Verified date: April 2020
• Source: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Contact: Tania TR RILCY
• Phone: +33140021126
• Email: trilcy[@]15-20.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 4, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pigmentary Retinopathy
• Retinitis Pigmentosa

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 1
Primary	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.	Month 1
Primary	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.	Month 1
Secondary	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.	Month 1