- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403814
Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines (SCOBES-AR)
Mixed Reality Prototype of Multimodal Screening for Early Detection of Cognitive Impairments in Elderly: Protocol Development and Usability Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wolfgang Staubmann, MSc
- Phone Number: +43 (0)316 5453 6768
- Email: wolfgang.staubmann@fh-joanneum.at
Study Locations
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-
Styria
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Graz, Styria, Austria, 8020
- Recruiting
- FH-Joanneum
-
Contact:
- Wolfgang Staubmann, BSc MSc
- Phone Number: 6768 433165453
- Email: wolfgang.staubmann@fh-joanneum.at
-
Contact:
- Monica Christova, Dr
- Email: monica.christova@fh-joanneum.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy individuals aged 60-75 years
- Interest in participating in the study
- Signed written informed consent form
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Smell Identification Test.
Time Frame: Day 1.
|
The test evaluates the olfactory functions.
Scale 0-12 points: higher values indicate better olfactory performance.
|
Day 1.
|
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).
|
Day 1.
|
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). |
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.
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.
|
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.
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.
|
Day 1.
|
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.
|
Day 1.
|
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.
|
Day 1.
|
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.
|
Day 1.
|
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.
|
Day 1.
|
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.
|
Day 1.
|
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.
|
Day 1.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability evaluation using video observations.
Time Frame: Day 1.
|
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. |
Day 1.
|
Usability evaluation using questionnaire.
Time Frame: Day 1.
|
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.
|
Day 1.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wolfgang Staubmann, MSc, FH Joanneum
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCOBES-AR Validation Study 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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