Alzheimer or Mild Cognitive ImpairmentARIADENCT04742465
ARIADE : Augmented Reality for Improving Autonomy in Dementia
A study of Alzheimer or Mild Cognitive Impairment, run by Rennes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer or Mild Cognitive Impairment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 25 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ARIADE : Augmented Reality for Improving Autonomy in Dementia. Creation, Implementation and Testing of an Augmented Reality Tool to Help People With Alzheimer's Type Dementia in Their Travels.
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.
Read the 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 these visual aids in augmented reality and determination of methods for measuring the effectiveness of devices for detecting wanderings (criteria linked to changes in gait: length of steps, frequency, regularity, direction , pauses) with detection using accelerometers (completed)
- A phase to assess the a priori acceptability of an Augmented Reality device by people with Alzheimer's disease or an Alzheimer-type MCI and by their relatives (completed)
The ARIADE project (9 months) will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of an Augmented Reality assistance, and of the devices adapted for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and their acceptance of the device.
Three routes each comprising seven intersections will allow us in 20 patients to compare the three different visual aids offered in augmented reality, i.e. arrows, path illumination and a little companion. We will assess the effectiveness of these aids to complete the course without trajectory errors, the safety of the participant throughout the course, the effectiveness of the system for detecting wanderings, and the acceptance of the device by the participant.
The participation of a patient in this phase will not exceed one hour, including breaks.
Patients will be called beforehand by one of the study investigators from a list of patients who volunteered to participate in clinical research studies held by the CMRR of Rennes University Hospital. Verification of the inclusion and non-inclusion criteria will be carried out by CMRR's investigating physicians from the patient's paper file and then during a usual follow-up consultation. The travel of participants to the Ker Lann gymnasium will be compensated.
Visual aids tested:
Based on previous experimental results, we aimed at testing the usability of three types of directional stimuli, i.e. information provided regarding the location of the user as well as the direction regarding the path to follow to reach a destination.
- The first type of aid proposed, which consists of the use of a directional arrow, is classic since it is the one whose use is most regularly reported in the literature. Arrows will be placed at ground level at each intersection.
- The second type of assistance consists of a path illumination. This type of help has only been tested with people with dementia as part of a single decision-making task. However, previous studies based on the illumination of certain areas indicate that this method is promising.
- Finally, the third type of help consists of the use of an animated companion standing in front of the person. This character does not interact with the person. However, it provides a social presence during the ride. The use of a personal aid should help on reducing the anxiety generated by navigation tasks. In the long term, and according to the results of this first study, the use of a learning companion, ie a type of educational agent that can provide a complex form of social presence and emotional feedback in a controlled environment, could be considered. To the best of our knowledge, a personified navigation aid has never been tested with people with dementia.
Exploratory, prospective, single-center, pilot study.
- Conditions
- Alzheimer or Mild Cognitive Impairment
- Being tested
- Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Destination
Reaching the final destination (ecological goal, determined by the configuration of the journey in a controlled environment).
Measured: 1 hour
Secondary outcomes (4)
Event of an endangerment
Safety of the participant: evaluation by the patient (Likert scale) and by an outside health professional (occupational therapist), with intervention in the event of endangerment, e.g. risk of falling (number of interventions noted)
Measured: 1 hour
6-minute walking test
Means of detecting participant wandering: step length, walking speed, asymmetry of step, pauses, deviation of the walking axis. Each patient will be compared to himself based on the parameters of the 6-minute walk test obtained previously
Measured: 1 hour
Senior Technology Acceptance
Senior Technology Acceptance : 3 items ranged from 1 to 4.
Measured: 1 hour
Personality
16PF5 questionnaire : The 16PF5 test by R.B. Cattel (1995) is a personality test in 16 primary scales. Indeed, Cattell's hierarchical system has 15 primary personality dimensions and a reasoning scale which are grouped into 5 global factors: Extraversion, Anxiety, Hardness-Intransigence, Independence and Self-control. Analyzes show that these 5 global factors are very close to the Big-Five: Extraversion, Neuroticism, Pleasantness, Openness, Consciousness.
For each item, three answers are proposed. The subject must check one. The 15 items of factor B, which assess the ability to reason, are grouped together at the end of the test, after the personality items. The raw notes are transformed into stens (standardized ten). Then the stens scores obtained for the 5 global factors and the 16 primary factors (scales) are represented in the form of a graph which reflects the personality patterns.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start7 Jun 2021
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer or Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- INRIA, Hybrid team, Ecole Centrale Nantes, laboratoire Ambiances, Architectures, Urbanités - UMR 1563 CNRS-ECN-ENSAN-ENSAG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742465
- Sponsor's protocol ID
- 35RC20_8889_ARIADE
- Other IDs
- 2021-A00062-39
- Acronym
- ARIADE
- Status last verified
- May 2023
- First submitted
- 1 Feb 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35007194
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARIADE : Augmented Reality for Improving Autonomy in Dementia. Creation, Implementation and Testing of an Augmented Reality Tool to Help People With Alzheimer's Type Dementia in Their Travels.
- ClinicalTrials.gov ID
- NCT04742465
- Acronym / sponsor ID
- ARIADE / 35RC20_8889_ARIADE
- Conditions
- Alzheimer or Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- INRIA, Hybrid team, Ecole Centrale Nantes, laboratoire Ambiances, Architectures, Urbanités - UMR 1563 CNRS-ECN-ENSAN-ENSAG
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 these visual aids in augmented reality and determination of methods for measuring the effectiveness of devices for detecting wanderings (criteria linked to changes in gait: length of steps, frequency, regularity, direction , pauses) with detection using accelerometers (completed)
- A phase to assess the a priori acceptability of an Augmented Reality device by people with Alzheimer's disease or an Alzheimer-type MCI and by their relatives (completed)
The ARIADE project (9 months) will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of an Augmented Reality assistance, and of the devices adapted for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and their acceptance of the device.
Three routes each comprising seven intersections will allow us in 20 patients to compare the three different visual aids offered in augmented reality, i.e. arrows, path illumination and a little companion. We will assess the effectiveness of these aids to complete the course without trajectory errors, the safety of the participant throughout the course, the effectiveness of the system for detecting wanderings, and the acceptance of the device by the participant.
The participation of a patient in this phase will not exceed one hour, including breaks.
Patients will be called beforehand by one of the study investigators from a list of patients who volunteered to participate in clinical research studies held by the CMRR of Rennes University Hospital. Verification of the inclusion and non-inclusion criteria will be carried out by CMRR's investigating physicians from the patient's paper file and then during a usual follow-up consultation. The travel of participants to the Ker Lann gymnasium will be compensated.
Visual aids tested:
Based on previous experimental results, we aimed at testing the usability of three types of directional stimuli, i.e. information provided regarding the location of the user as well as the direction regarding the path to follow to reach a destination.
- The first type of aid proposed, which consists of the use of a directional arrow, is classic since it is the one whose use is most regularly reported in the literature. Arrows will be placed at ground level at each intersection.
- The second type of assistance consists of a path illumination. This type of help has only been tested with people with dementia as part of a single decision-making task. However, previous studies based on the illumination of certain areas indicate that this method is promising.
- Finally, the third type of help consists of the use of an animated companion standing in front of the person. This character does not interact with the person. However, it provides a social presence during the ride. The use of a personal aid should help on reducing the anxiety generated by navigation tasks. In the long term, and according to the results of this first study, the use of a learning companion, ie a type of educational agent that can provide a complex form of social presence and emotional feedback in a controlled environment, could be considered. To the best of our knowledge, a personified navigation aid has never been tested with people with dementia.
Exploratory, prospective, single-center, pilot study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Augmented reality | Experimental | Other: Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.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 |
Primary outcome
Destination
Time frame: 1 hour
Reaching the final destination (ecological goal, determined by the configuration of the journey in a controlled environment).
4 secondary outcomes
Event of an endangerment
Time frame: 1 hour
6-minute walking test
Time frame: 1 hour
Senior Technology Acceptance
Time frame: 1 hour
Personality
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 35007194Pillette 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alzheimer or Mild Cognitive Impairment, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Destination (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04742465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.