Mobility Protocol Adapted for Advanced Visually Impaired Subjects

NCT04419285 | Unknown DMC

• 2 other identifiers: P19-042019-A00937-50
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pigmentary Retinopathy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Measurement of postural parameters

  Month 1

Study Arms (1)

Retinitis Pigmentosa patients

EXPERIMENTAL

50 patients with very severe Retinitis Pigmentosa

Behavioral: Locomotion task; Behavioral: Posturology task SOT (Sensory Organization Test); Behavioral: The quality of life questionnaire

Interventions

Locomotion task BEHAVIORAL

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

Retinitis Pigmentosa patients

Posturology task SOT (Sensory Organization Test) BEHAVIORAL

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

Retinitis Pigmentosa patients

The quality of life questionnaire BEHAVIORAL

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)

Retinitis Pigmentosa patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women
• Inability to give personal consent
• 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

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Sites (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Saddek SM MOHAND-SAID, MD

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tania TR RILCY

CONTACT

+33140021126; trilcy@15-20.fr

Hayet HS SERHANE

CONTACT

+3314021144; hserhane@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The exploratory study will focus on 50 subjects with Retinitis Pigmentosa at very advanced stages

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: June 5, 2020
• Study Start: March 2, 2020
• Primary Completion: June 2, 2024
• Study Completion: June 4, 2024
• Last Updated: June 5, 2020

Record last verified: 2020-04

Locations

FR (1)