Test and Usability of Mixed-reality Screening Tool for Early Detection of Cognitive Declines

NCT ID: NCT05403814

Last Updated: 2022-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Aging Cognitive Change

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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observational screening procedure (no intervention)

observational screening procedure (no intervention)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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FH Joanneum Gesellschaft mbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Staubmann, MSc

Role: PRINCIPAL_INVESTIGATOR

FH Joanneum

Locations

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FH-Joanneum

Graz, Styria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Wolfgang Staubmann, MSc

Role: CONTACT

+43 (0)316 5453 6768

Facility Contacts

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Wolfgang Staubmann, BSc MSc

Role: primary

433165453 ext. 6768

Monica Christova, Dr

Role: backup

Related Links

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http://www.mindtools.com

Eisenhower's Urgent/Important Principle: Using Time Effectively, Not Just Efficiently

Other Identifiers

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SCOBES-AR Validation Study 2

Identifier Type: -

Identifier Source: org_study_id

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