Status:
COMPLETED
ARIADE : Augmented Reality for Improving Autonomy in Dementia
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
INRIA, Hybrid team
Ecole Centrale Nantes, laboratoire Ambiances, Architectures, Urbanités - UMR 1563 CNRS-ECN-ENSAN-ENSAG
Conditions:
Alzheimer or Mild Cognitive Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Navigating according to a specific goal is a common activity of everyday life. Spatial navigation requires the implementation of motor and perceptual functions (sight, walking, proprioception), but al...
Detailed Description
The ARIADE project was preceded by: * A phase of systematic literature review and selection of the different types of visual aids to be tested (completed) * A design phase with implementation of thes...
Eligibility Criteria
Inclusion
- Existence of a probable Alzheimer's disease (AD) according to the NIAA criteria (McKhann et al., 2011) with a Mini Mental State Examination (MMSE) greater than or equal to 20 (threshold defined in order not to include certain participants whose comprehension problems would not be compatible with the ARIADE project) OR Existence of an Alzheimer-type Mild Cognitive Impairment (MCI) according to the criteria of Albert et al. (2011)
- Adult person
- Affiliation to a social security scheme
- Free, informed and signed written consent The diagnosis of dementia or MCI of the probable Alzheimer type will be made by the medical and paramedical team of the Memory, Resources and Research Center (CMRR) of the Rennes University Hospital (Department of Dr Serge Belliard). The proposal for voluntary participation in the ARIADE project will be made by one of the project's clinical investigators to CMRR patients who have already expressed their interest in participating in a clinical research project (list already updated by the CMRR team) and to members of the Association Bistrot Mémoire de Rennes, partner of the ARIADE project, after validation of the inclusion and non-inclusion criteria by the CMRR team at Rennes University Hospital.
Exclusion
- Clinical history of neurological event in the central nervous system
- Untreated anxiety-depressive syndrome with a sub-score A (anxiety) or D (depression) on the HADS questionnaire, i.e. Hospital Anxiety and Depression Scale, greater than or equal to 11
- Moderate or greater deafness (loss of at least 40dB from the "good" ear) or an asymmetry of more than 10dB between the left and right ear on tone audiometry
- Insufficient corrected visual acuity (decree of August 31, 2010 for driving a light vehicle) (incompatibility if binocular visual acuity is less than 5 / 10th OR if the acuity of one eye is less than 1 / 10th and the acuity of the other eye is less than 5 / 10th)
- Severe comprehension disorder, preventing the understanding of the instructions
- Severe behavioral disorder, not allowing participation in the experiment (DSM-V)
- Acute decompensated pathology (example: heart failure)
- Lack of social security
- Safeguarding effective justice
- Severe balance disorders noted when performing a Timed Up and Go Test with a risk of falling noted by the assessor or an inability to perform a 6-minute walk test.
- Non-French speaking person
- Pregnant or breastfeeding woman
- The existence of a simple curatorship, a reinforced curatorship or a tutorship will not constitute a criterion for non-inclusion. Indeed, people with a neurocognitive disorder under legal protection are those who probably present the most loss of autonomy and loss of social participation and inclusion in the city, in connection with the disease and / or with isolation. social and family. These are therefore the people most in need of technological aids that we are going to offer. It therefore seems illogical to exclude them insofar as they will represent the sub-part of this population that will need them the most and will probably derive great benefit from them, with minimal risks in this study.
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04742465
Start Date
June 7 2021
End Date
June 25 2021
Last Update
May 23 2023
Active Locations (1)
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1
Rennes University Hospital
Rennes, France, 35033