Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (REEDUC-ACP)

March 21, 2023 updated by: Centre Hospitalier Universitaire de Nice

Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)

Posterior cortical atrophy (PCA) is manifested by neuro-visual disorders that alter the spatial location of objects, their manipulation and/or recognition. Its etiology is most often neurodegenerative, with a major impact on the autonomy and mood of patients and their families. Few studies have focused on non-medication management of these disorders.

The present study thus has a double objective: the development of a complete tool to work on the recognition, localization and/or manipulation of objects; and the evaluation of the effectiveness of this type of management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alpes-Maritime
      • Nice, Alpes-Maritime, France, 06100
        • Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
        • Contact:
        • Principal Investigator:
          • MOUTON Aurélie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >50 years old
  • Male or Female
  • Patients with a diagnosis of PCA according to the criteria of Tang-Wai et al (2004)
  • MMS>15
  • Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator), with oral consent of the patient in all cases
  • Anti-Alzheimer's and psychotropic treatments stable for one month, if taken by the patient
  • Affiliation to a social security system

Exclusion Criteria:

  • Uncorrected visual disorders with non-degenerative etiology (AV<0.5)
  • Person under the protection of justice
  • Pregnant women (a pregnancy test will be performed in premenopausal women)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recognition of objects
Patients will do the therapy in the following order: object location, object manipulation and object recognition
Behavioral: Recognition of objects
  • Name of shapes / colors / images / objects
  • Classification of shapes / colors / images / objects
Experimental: Location of objects
Patients will do the therapy in the following order: object recognition, object location, and object manipulation
Behavioral: Location of objects
  • Search for frequent/rarse targets among distractors sharing one or more characteristics with the target
  • Hit/catch a stationary/mobile target as quickly as possible
Experimental: Manipulation of objects
Patients will do the therapy in the following order: object manipulation, object recognition and object location
Behavioral: Manipulation of objects
  • Storage of shapes/objects
  • Use of everyday objects (pen, cutlery, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness evaluation
Time Frame: At week 34
Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .
At week 34

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: MOUTON Aurélie, Ph, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2022

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-AOI-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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