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
About this trial
This is an interventional treatment trial for Posterior Cortical Atrophy
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)
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
NCT ID
NCT04041089
First Posted
July 30, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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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