ARIADE : Augmented Reality for Improving Autonomy in Dementia

NCT04742465 | Completed

• 2 other identifiers: 35RC20_8889_ARIADE2021-A00062-39
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 also various cognitive functions (executive functions, memory, spatial orientation skills). Many people affected by a neurodegenerative disease have topographical difficulties which have a major impact on their autonomy in daily life, by gradually limiting their movements outside their home, then inside their home, and which are the main factor leading to the institutionalization of this population. People with dementia or MCI (Mild Cognitive Impairment) of the Alzheimer type, according to the definition of the NIAA (National Institute on Aging-Alzheimer's Association) have navigation and spatial memory disorders, with difficulty in acquiring mental spatial representations of their environment. These topographical difficulties have been shown to be related to the reduction in volume of the temporal cortex, in particular the hippocampal regions, as well as to atrophy of the retrosplenial cortex. Augmented Reality (AR), often defined as an intermediary between the totally artificial world of VR and the real world in which we operate, makes it possible in particular to add summary information to the natural environment in which a participant operates. Even if, in particular in outside environment, AR must solve many challenges, such as the integration of the real and virtual worlds in real time, the selection of the modalities of restitution of information, its use is exponential in the medical field, in particular in surgery for the assistance of the practitioner, but also in the field of sensory substitution, in particular to facilitate the movements of people with visual impairment. Other works focused in helping people with dementia of the Alzheimer type, such as those of Quintana and Favela (2012) who proposed preliminary systems of annotations in AR. Hervás et al. were the first in 2014 to test the use of augmented reality to provide navigation assistance to people with dementia. In 2017, Firouzian et al. as well as Sejunaite et al. implemented related systems. Firouzian et al. have developed spectacle frames comprising around ten LED lights in order to provide directional indications to people who moved outdoor. However, the influence of this system on navigation performance has not been tested yet. On the other hand, although simple to develop, this system requires training on the part of the users and only makes it possible to provide directional information, which is not recommended for the implementation of a tool for this population. Finally, Sejunaite et al. used an environmentally tested smart glasses to allow users to display information in the form of a map to help older people navigate independently. However, the literature review indicates that even increased card use does not seem to be suitable for people with dementia or Alzheimer's-type MCI. Finally, these two tools do not allow navigational information to be co-located in the field of vision of people, which represents one of the major advantages of augmented reality. To our knowledge, there is not yet an AR device providing co-located information in the environment dedicated to outdoor navigation of people with dementia or Alzheimer's type MCI.

Conditions

Alzheimer or Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Destination

  Reaching the final destination (ecological goal, determined by the configuration of the journey in a controlled environment).

  1 hour

Secondary Outcomes (4)

• Event of an endangerment

  1 hour

• 6-minute walking test

  1 hour

• Senior Technology Acceptance

  1 hour

• Personality

  1 hour

Study Arms (1)

Augmented reality

EXPERIMENTAL

Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment. The ARIADE project will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of Augmented Reality assistance, that of the devices for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and his acceptance of the device. Three routes each comprising seven intersections, i.e. a location requiring a decision on navigation, will allow us in 20 patients to objectively compare the three different visual aids offered in augmented reality, i.e. arrows, light path, animated companion.

Other: Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.

Interventions

Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment. OTHER

Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment. The ARIADE project will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of Augmented Reality assistance, that of the devices for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and his acceptance of the device. Three routes each comprising seven intersections, i.e. a location requiring a decision on navigation, will allow us in 20 patients to objectively compare the three different visual aids offered in augmented reality, i.e. arrows, light path, animated companion.

Augmented reality

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead
• INRIA, Hybrid team: collaborator
• Ecole Centrale Nantes, laboratoire Ambiances, Architectures, Urbanités - UMR 1563 CNRS-ECN-ENSAN-ENSAG: collaborator

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Related Publications (1)

• Pillette L, Moreau G, Normand JM, Perrier M, Lecuyer A, Cogne M. A Systematic Review of Navigation Assistance Systems for People With Dementia. IEEE Trans Vis Comput Graph. 2023 Apr;29(4):2146-2165. doi: 10.1109/TVCG.2022.3141383. Epub 2023 Feb 28.

  PMID: 35007194 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Amyloid beta-Protein Precursor

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

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: Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment. The ARIADE project will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of Augmented Reality assistance, that of the devices for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and his acceptance of the device. Three routes each comprising seven intersections, i.e. a location requiring a decision on navigation, will allow us in 20 patient "testers" to objectively compare the three different visual aids offered in augmented reality, i.e. arrows, light path, animated character.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 8, 2021
• Study Start: June 7, 2021
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)