AgingSCOBES-ARNCT05403814
Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines
An observational study of Aging and Cognitive Change, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
Trial summary
The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Change
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 25 Apr 2022to Oct 2022
- Phase
- Observational
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the city of Graz and Graz suburbs
Who may be able to join
- Healthy individuals aged 60-75 years
- Interest in participating in the study
- Signed written informed consent form
Who cannot join
- Clinical diagnosis of mild cognitive impairment or dementia
- Clinical diagnosis of mental illness (e.g. depression, psychosis)
- Reduced mobility (walking aid, wheelchair)
- Aided hearing or visual impairment
- Participation in any other cognitive training study within the last 6 months
- Present guardianship according to the provisions of the Austrian adult protection law
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
FH-Joanneum
Graz, Styria, 8020
Wolfgang Staubmann, BSc MSc, 433165453 ext. 6768, wolfgang.staubmann@fh-joanneum.at
Monica Christova, Dr, monica.christova@fh-joanneum.at
About this study
Official title: Mixed Reality Prototype of Multimodal Screening for Early Detection of Cognitive Impairments in Elderly: Protocol Development and Usability Study
The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.
Read the detailed description
Early diagnosis of cognitive impairments is an important step in the adequate management of dementia. The project "Smart Cognition \& Behavior Screening powered by Augmented Reality" (SCOBES-AR) aims to develop a multimodal screening tool (MST) for early detection of cognitive impairments using augmented and virtual reality. In the first project phase validated assessments were selected, combined in MST and tested in 174 healthy elderly adults. In the present project phase, the developed MST will be partly enhanced by mixed reality (MR). This MR-enhanced prototype of screening tool (MR-MST) will be tested and compared to the previously developed MST. In addition, the usability of this enhanced prototype will be examined.
The study aims to establish a protocol for implementation and usability of MR-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.
In this cross-over design study protocol 100 healthy participants (aged 60-75years) will be screened for cognitive declines using: i) specially developed MST (assessment of cognitive functions, olfactory sensitivity, nutritional preferences, gait parameters, reaction times, activities of daily living, and ii) MR-enhanced MST in which the assessments of cognitive functions, reaction time, activities of daily living and gait are performed using tailor made software and augmented reality and virtual reality hardware. The results of the MR-enhanced MST will be compared with those without MR. The usability of the developed MR-enhanced MST will be tested on 10 investigators and 10 test participants using observed summative evaluation and the co-discovery method and on 2 usability experts using the co-discovery method.
This study was funded by the Austrian Research Promotion Agency and received Ethic Vote from the Ethic committee of the Medical University of Graz. The MR-MST prototype and the study protocol for the present study were developed. To date, no results are available for this study protocol.
The development of the MR-MST prototype enables identifying best practise procedure for evaluating cognitive declines in the elderly using multimodal and MR-enhanced model.
- Conditions
- Aging, Cognitive Change
- Being tested
- observational screening procedure (no intervention)
- Keywords
- mixed reality, multimodal screening, cognitive impairment, smart cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational screening procedure (no intervention)Other
observational screening procedure (no intervention)
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Smell Identification Test.
The test evaluates the olfactory functions. Scale 0-12 points: higher values indicate better olfactory performance.
Measured: Day 1.
Food-Frequency-Index.
This assessment evaluates the dietary behavior. Dietary behavior is classified as poor (< 32 points), moderate (32-34 points), good (35-39 points), and very good (> 39 points).
Measured: Day 1.
Dementia-Detection-Test.
The test evaluates the cognitive functions (recall of word list, number transcoding, semantic word fluency, digit span reverse).
Scale 0-18 points: probability of dementia (0-8 points), light cognitive changes (9-12 points), healthy (13-18 points).
Measured: Day 1.
Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with pen-and-paper.
For each of the 2 items ("mobility" and "finances") a score 0-6 points is given. Higher score indicates better performance.
Measured: Day 1.
Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with Virtual Reality.
For each of the 2 items ("mobility" and "finances") a score 0-6 points is given using tailor-made software. Higher score indicates better performance.
Measured: Day 1.
Trail-Making Test, performed with pen-and-paper.
The test evaluates the cognitive abilities and consists of two parts: connecting numbers and connecting numbers and letters in ascending order. The time (sec.) to perform the task is measured using a stop watch. Shorter time indicates better performance.
Measured: Day 1.
Trail-Making Test, performed with Augmented Reality.
The test evaluates the cognitive abilities and consists of two parts: connecting numbers and connecting numbers and letters in ascending order. The time (sec.) to perform the task is measured using a tailor-made software. Shorter time indicates better performance.
Measured: Day 1.
Reaction Time Test, performed with contact plates.
The test evaluates the complex reactivity (eye-hand, eye-leg and eye-hand-leg reactions) in response to visual signals displayed in a randomized order. The time (sec.) to perform the task is measured using a stop watch. Shorter time indicates better performance.
Measured: Day 1.
Reaction Time Test, performed with smartphone mobile application.
The test evaluates the complex reactivity (eye-hand, eye-leg and eye-hand-leg reactions) in response to visual signals displayed in a randomized order. The time (sec.) to perform the task is measured using mobile application. Shorter time indicates better performance.
Measured: Day 1.
Dual Task Assessments, performed with direct observation.
The assessment measures the influence of a cognitive task on gait parameters. Time to complete the task (sec.), number of steps and walking speed (steps/min.) will be calculated for the single task (walking) and the double task (walking and counting). Bigger difference between the parameters in both tasks indicates cognitive declines.
Measured: Day 1.
Dual Task Assessments, performed with Augmented Reality.
The assessment measures the influence of a cognitive task on gait parameters. Time to complete the task (sec.), number of steps and walking speed (steps/min.) will be calculated for the single task (walking) and the double task (walking and counting) using tailor-made software. Bigger difference between the parameters in both tasks indicates cognitive declines.
Measured: Day 1.
Secondary outcomes (2)
Usability evaluation using video observations.
Videos of the test procedure obtained from the target groups will be evaluated by usability experts.
The video observations will be evaluated using the "Eisenhower's Urgent/Important Principle", in which items are evaluated as: "not urgent" - "urgent" and as "not important" - "important", whereby the "urgent" and the "important" items indicate higher needs of improvement.
Measured: Day 1.
Usability evaluation using questionnaire.
Questionnaire addressing the personal experience with the screening procedure will be obtained from the target groups and will be evaluated by usability experts. The questionnaires will be evaluated using a score system (1-5), where 1 indicates very good usability.
Measured: Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start25 Apr 2022
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FH Joanneum Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Staubmann, MSc, Principal investigator, FH Joanneum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403814
- Sponsor's protocol ID
- SCOBES-AR Validation Study 2
- Acronym
- SCOBES-AR
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Reality Prototype of Multimodal Screening for Early Detection of Cognitive Impairments in Elderly: Protocol Development and Usability Study
- ClinicalTrials.gov ID
- NCT05403814
- Acronym / sponsor ID
- SCOBES-AR / SCOBES-AR Validation Study 2
- Conditions
- Aging, Cognitive Change
- Keywords
- mixed reality, multimodal screening, cognitive impairment, smart cognition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- FH Joanneum Gesellschaft mbHIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 3 Jun 2022 (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.
The aim of this study as part of the SCOBES-AR project is to establish and test a protocol for implementation and usability of mixed reality-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.
Detailed description
Early diagnosis of cognitive impairments is an important step in the adequate management of dementia. The project "Smart Cognition \& Behavior Screening powered by Augmented Reality" (SCOBES-AR) aims to develop a multimodal screening tool (MST) for early detection of cognitive impairments using augmented and virtual reality. In the first project phase validated assessments were selected, combined in MST and tested in 174 healthy elderly adults. In the present project phase, the developed MST will be partly enhanced by mixed reality (MR). This MR-enhanced prototype of screening tool (MR-MST) will be tested and compared to the previously developed MST. In addition, the usability of this enhanced prototype will be examined.
The study aims to establish a protocol for implementation and usability of MR-enhanced multidisciplinary screening tool for early detection of cognitive impairments in the elderly.
In this cross-over design study protocol 100 healthy participants (aged 60-75years) will be screened for cognitive declines using: i) specially developed MST (assessment of cognitive functions, olfactory sensitivity, nutritional preferences, gait parameters, reaction times, activities of daily living, and ii) MR-enhanced MST in which the assessments of cognitive functions, reaction time, activities of daily living and gait are performed using tailor made software and augmented reality and virtual reality hardware. The results of the MR-enhanced MST will be compared with those without MR. The usability of the developed MR-enhanced MST will be tested on 10 investigators and 10 test participants using observed summative evaluation and the co-discovery method and on 2 usability experts using the co-discovery method.
This study was funded by the Austrian Research Promotion Agency and received Ethic Vote from the Ethic committee of the Medical University of Graz. The MR-MST prototype and the study protocol for the present study were developed. To date, no results are available for this study protocol.
The development of the MR-MST prototype enables identifying best practise procedure for evaluating cognitive declines in the elderly using multimodal and MR-enhanced model.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the city of Graz and Graz suburbs
Key inclusion criteria (3 listed)
- Healthy individuals aged 60-75 years
- Interest in participating in the study
- Signed written informed consent form
Key exclusion criteria (6 listed)
- Clinical diagnosis of mild cognitive impairment or dementia
- Clinical diagnosis of mental illness (e.g. depression, psychosis)
- Reduced mobility (walking aid, wheelchair)
- Aided hearing or visual impairment
- Participation in any other cognitive training study within the last 6 months
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 |
|---|---|---|
| observational screening procedure (no intervention)observational screening procedure (no intervention) | Other | – |
Primary outcome
Brief Smell Identification Test.
Time frame: Day 1.
The test evaluates the olfactory functions. Scale 0-12 points: higher values indicate better olfactory performance.
Food-Frequency-Index.
Time frame: Day 1.
This assessment evaluates the dietary behavior. Dietary behavior is classified as poor (< 32 points), moderate (32-34 points), good (35-39 points), and very good (> 39 points).
Dementia-Detection-Test.
Time frame: Day 1.
The test evaluates the cognitive functions (recall of word list, number transcoding, semantic word fluency, digit span reverse). Scale 0-18 points: probability of dementia (0-8 points), light cognitive changes (9-12 points), healthy (13-18 points).
Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with pen-and-paper.
Time frame: Day 1.
For each of the 2 items ("mobility" and "finances") a score 0-6 points is given. Higher score indicates better performance.
Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment: items "mobility" and "finances", performed with Virtual Reality.
Time frame: Day 1.
For each of the 2 items ("mobility" and "finances") a score 0-6 points is given using tailor-made software. Higher score indicates better performance.
Trail-Making Test, performed with pen-and-paper.
Time frame: Day 1.
The test evaluates the cognitive abilities and consists of two parts: connecting numbers and connecting numbers and letters in ascending order. The time (sec.) to perform the task is measured using a stop watch. Shorter time indicates better performance.
Trail-Making Test, performed with Augmented Reality.
Time frame: Day 1.
The test evaluates the cognitive abilities and consists of two parts: connecting numbers and connecting numbers and letters in ascending order. The time (sec.) to perform the task is measured using a tailor-made software. Shorter time indicates better performance.
Reaction Time Test, performed with contact plates.
Time frame: Day 1.
The test evaluates the complex reactivity (eye-hand, eye-leg and eye-hand-leg reactions) in response to visual signals displayed in a randomized order. The time (sec.) to perform the task is measured using a stop watch. Shorter time indicates better performance.
Reaction Time Test, performed with smartphone mobile application.
Time frame: Day 1.
The test evaluates the complex reactivity (eye-hand, eye-leg and eye-hand-leg reactions) in response to visual signals displayed in a randomized order. The time (sec.) to perform the task is measured using mobile application. Shorter time indicates better performance.
Dual Task Assessments, performed with direct observation.
Time frame: Day 1.
The assessment measures the influence of a cognitive task on gait parameters. Time to complete the task (sec.), number of steps and walking speed (steps/min.) will be calculated for the single task (walking) and the double task (walking and counting). Bigger difference between the parameters in both tasks indicates cognitive declines.
Dual Task Assessments, performed with Augmented Reality.
Time frame: Day 1.
The assessment measures the influence of a cognitive task on gait parameters. Time to complete the task (sec.), number of steps and walking speed (steps/min.) will be calculated for the single task (walking) and the double task (walking and counting) using tailor-made software. Bigger difference between the parameters in both tasks indicates cognitive declines.
2 secondary outcomes
Usability evaluation using video observations.
Time frame: Day 1.
Usability evaluation using questionnaire.
Time frame: Day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Project homepageLink provided by the sponsor.
- Eisenhower's Urgent/Important Principle: Using Time Effectively, Not Just EfficientlyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Wolfgang Staubmann, MSc principal investigator
FH Joanneum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Cognitive Change, run by FH Joanneum Gesellschaft mbH at 1 site in Austria.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Staubmann, MSc (+43 (0)316 5453 6768, wolfgang.staubmann@fh-joanneum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Smell Identification Test. (time frame: Day 1.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022.