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

Primary Purpose

Posterior Cortical Atrophy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recognition of objects
Location of objects
Manipulation of objects
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Cortical Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Recognition of objects

Location of objects

Manipulation of objects

Arm Description

Patients will do the therapy in the following order: object location, object manipulation and object recognition

Patients will do the therapy in the following order: object recognition, object location, and object manipulation

Patients will do the therapy in the following order: object manipulation, object recognition and object location

Outcomes

Primary Outcome Measures

Effectiveness evaluation
Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .

Secondary Outcome Measures

Full Information

First Posted
July 30, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04041089
Brief Title
Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy
Acronym
REEDUC-ACP
Official Title
Development and Evaluation of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy (PCA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Cortical Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recognition of objects
Arm Type
Experimental
Arm Description
Patients will do the therapy in the following order: object location, object manipulation and object recognition
Arm Title
Location of objects
Arm Type
Experimental
Arm Description
Patients will do the therapy in the following order: object recognition, object location, and object manipulation
Arm Title
Manipulation of objects
Arm Type
Experimental
Arm Description
Patients will do the therapy in the following order: object manipulation, object recognition and object location
Intervention Type
Behavioral
Intervention Name(s)
Recognition of objects
Intervention Description
Name of shapes / colors / images / objects Classification of shapes / colors / images / objects
Intervention Type
Behavioral
Intervention Name(s)
Location of objects
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Manipulation of objects
Intervention Description
Storage of shapes/objects Use of everyday objects (pen, cutlery, etc.)
Primary Outcome Measure Information:
Title
Effectiveness evaluation
Description
Effectiveness will be evaluated a score based on success rate (from 0 to 10), reaction time and eye-recording .
Time Frame
At week 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOUTON Aurélie, Ph
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice
City
Nice
State/Province
Alpes-Maritime
ZIP/Postal Code
06100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of the Effectiveness of Rehabilitation Tools for Neurovisual Disorders in Patients With Posterior Cortical Atrophy

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