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

NCT05403814 | Unknown

• 1 other identifier: SCOBES-AR Validation Study 2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging; Cognitive Change

Keywords

mixed reality; multimodal screening; cognitive impairment; smart cognition

Outcome Measures

Primary Outcomes (11)

• Brief Smell Identification Test.

  The test evaluates the olfactory functions. Scale 0-12 points: higher values indicate better olfactory performance.

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Day 1.

Secondary Outcomes (2)

• Usability evaluation using video observations.

  Day 1.

• Usability evaluation using questionnaire.

  Day 1.

Interventions

observational screening procedure (no intervention) OTHER

observational screening procedure (no intervention)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Residents of the city of Graz and Graz suburbs

You may qualify if:

• Healthy individuals aged 60-75 years
• Interest in participating in the study
• Signed written informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• FH Joanneum Gesellschaft mbH: lead

Study Sites (1)

FH-Joanneum

Graz, Styria, 8020, Austria

RECRUITING

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wolfgang Staubmann, MSc

  FH Joanneum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Staubmann, MSc

CONTACT

+43 (0)316 5453 6768; wolfgang.staubmann@fh-joanneum.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 3, 2022
• Study Start: April 25, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

AU (1)