Condition category
Mental and Behavioural Disorders
Date applied
29/08/2019
Date assigned
10/09/2019
Last edited
02/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dementia is a syndrome (a group of related symptoms) associated with an ongoing decline of brain functioning. The aim of the study was to evaluate the effectiveness of VR-based cognitive training for older adults and to compare this effectiveness among older adults without cognitive impairment and with mild dementia.

Who can participate?
Adults aged 60 years or older with no cognitive impairment or with mild dementia.

What does the study involve?
Cognitive training with the use of GRADYS software – a computer game with elements of VR was used. It consists of eight sessions and lasts four weeks. The training program is preceded and followed by a cognitive assessment of processes corresponding to the modules of the game which aim to improve:
1. Attention
2. Memory
3. Language
4. Visuospatial processing.

What are the possible benefits and risks of participating?
Participation in the study is associated with possible benefits in cognitive functioning resulting from the training. All subjects were also diagnosed with their current cognitive status, including dementia screening tests. No financial benefits were provided for the participants.
The only inconvenience arising from participation in the study could have been the cybersickness - unwanted experiences associated with the use of VR headset (information leaflet in the attachment to the informed consent for participants, please find it attached). Participants experiencing serious cybersickness were excluded from further training.

Where is the study run from?
Kazimierz Wielki University Institute of Psychology, Poland

When is the study starting and how long is it expected to run for?
December 2015 to August 2016

Who is funding the study?
The National Centre for Research and Development, Poland

Who is the main contact?
Dr Ludmila Zając-Lamparska
lzajac@ukw.edu.pl

Trial website

http://eee.gradys.eu

Contact information

Type

Scientific

Primary contact

Dr Ludmiła Zając-Lamparska

ORCID ID

http://orcid.org/0000-0003-4618-547X

Contact details

Kazimierz Wielki University Institute of Psychology
ul. Staffa 1
Bydgoszcz
85-867
Poland
+48604251762
lzajac@ukw.edu.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IS-1/004/NCBR/2014

Study information

Scientific title

GRADYS – computer simulation software with virtual reality elements for enhancement of cognitive functions in the elderly with healthy aging and with dementia diseases

Acronym

GRADYS

Study hypothesis

1. Training using GRADYS game will result in an improvement in performance and reaching higher levels of the game difficulty in training modules.
2. The effect of the training will result in an improvement in the performance of standard cognitive measures.
3. Belonging to the group of non-demented and mildly demented older adults will differentiate the participants in terms of cognitive performance in pretest and in terms of training effects. The cognitive performance in pretest will be better in non-demented older adults. Training effects in both groups will be significant and positive, but in the group of non-demented older adults they will be greater.

Ethics approval

Approved 26/04/2016, Bioethics Committee of the Nicolaus Copernicus University in Toruń functioning at Collegium Medicum in Bydgoszcz (Komisja Bioetyczna Uniwersytetu Mikołaja Kopernika w Toruniu przy Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, ul. M. Curie Skłodowskiej 9, 85-094 Bydgoszcz; +48 52 585-35-63; komisja.bioetyczna@cm.umk.pl), ref: 320/2016

Study design

Non randomised interventional pretest-posttest study design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet. The participant information sheet is in Polish because all the participants were Polish.

Condition

Mild dementia

Intervention

There were two groups: non-demented and mildly demented older adults. Participants with mild dementia were recruited from patients of a geriatric clinic, from patients of a healthcare facility of the "Nowa Wspolna Droga" Association in Gniezno and through advertisement. Participants without cognitive impairment were recruited through advertisement.

VR-based cognitive training with the use of GRADYS game. The game contains 4 modules:
1. Attention
2. Memory
3. Language
4. Visuospatial processing

The training lasted 4 weeks, it comprised 8 individual training sessions, two per week. A single session lasted 45 minutes to one hour.

There are separate game scripts for four different cognitive domains: attention, memory, language, visuospatial processing. Each cognitive domain has its own gameplay, composed of several tasks involving the same cognitive function and forming a coherent storyline inspired by everyday life.

Attention: The tasks of the attention module were designed to activate selective and focused attention, sustained attention (vigilance), divided and alternating attention, and executive attention.
Example: On their way to the shop the player needs to cross the street, tramway tracks and a bike lane. To get to the other side of the street the player needs to mind the current traffic lights and the traffic on the road. When the difficulty level rises, the situation in the street gets more complicated and the number of elements that need to be taken into consideration when making the decision about crossing the street increases.

Memory: The tasks designed to stimulate memory functions concern short-term memory, long-term memory, and prospective memory.
Example: The player goes to the kitchen to prepare the salad. The recipe is displayed in the centre of the visual field for as long as the player needs to memorize all the ingredients. The number of the ingredients to memorize rises with the difficulty level of the game. To prepare the salad the player has to select the ingredients visible on the table. Once the salad is ready, the next task is to call a friend and give them the recipe.

Language: The tasks stimulating language functions are based on spoken and written text processing. To achieve this, one needs to activate phonological, spelling, semantic, and syntactic knowledge.
Example: The first task is to use an ATM machine. The player has to withdraw money and top up his phone account. To achieve this, they need to follow the instructions displayed on the ATM screen. The more difficult the game, the more complex the instructions provided to the player, and the more options to choose from on the screen.

Visuospatial processing:
The visuospatial modules in the game rely on visuospatial analysis, mental rotation, and visual search.
Example: The player needs to glue broken dish pieces together. On the desk, the player can see all parts that need to be glued together. Additionally, in the centre, the player can see in a different colour the piece that should be picked from the available ones and glued as the next one. To select the right piece the player has to mentally rotate it as the pieces on the desk are placed in a different position than the part being displayed in the centre. The complexity of the dish and hence the number of parts to glue together rise with the difficulty level.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Cognitive abilities measured at baseline and at 8-weeks
1. Attention measured using: Digit Symbol from WAIS – R (PL); Colour trial test (CTT) – Adult version, d2 Test of Attention (indices: WZ – speed of processing, %B – percentage of errors, WZ-B – error-corrected speed of processing, ZK – ability to concentrate);
2. Memory measured using: Digit Span from WAIS – R (PL), Benton Visual Retention Test (BVRT), Rey Auditory Verbal Learning Test (AVLT), Famous Faces Test, Rey-Osterrieth complex figure test (ROCF) – delayed reproduction;
3. Language measured using: Verbal Fluency from ACE – III; Boston Naming Test (BNT);
4. Visuospatial processing measured using: Block Design from WAIS – R (PL), Rey-Osterrieth complex figure test (ROCF) – direct copying.

Secondary outcome measures

None

Overall trial start date

28/03/2013

Overall trial end date

30/09/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Polish citizens for whom Polish was a native language
2. 60 years or older
3. Cognitively healthy older adults: Mini-Mental State Examination score of 27-30
4. Older adults with mild dementia: Mini-Mental State Examination score of 19-23

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

150

Total final enrolment

150

Participant exclusion criteria

1. Mental disorders
2. Serious somatic illnesses
3. Auditory and motor impairments preventing the use of the game peripherals
4. Taking medication disrupting cognitive functioning
5. Cybersickness

Recruitment start date

01/12/2015

Recruitment end date

01/08/2016

Locations

Countries of recruitment

Poland

Trial participating centre

Kazimierz Wielki University
ul. Chodkiewicza 30
Bydgoszcz
85-064
Poland

Trial participating centre

Nicolaus Copernicus University in Toruń Ludwik Rydygier Collegium Medicum in Bydgoszcz
Jagiellońska 13-15
Bydgoszcz
85-067
Poland

Trial participating centre

„Nowa Wspolna Droga” Association
Grudzińskiego 18A/8
Swarzędz
62-020
Poland

Trial participating centre

Wyższa Szkoła Technologii Informatycznych w Warszawie (ang. The University of Information Technology in Warsaw)
Okopowa 59
Warszawa
01-043
Poland

Sponsor information

Organisation

The National Centre for Research and Development, Poland

Sponsor details

Narodowe Centrum Badań i Rozwoju
Nowogrodzka 47a
Warszawa
00-695
Poland
+48 22 390 74 01
sekretariat@ncbr.gov.pl

Sponsor type

Government

Website

https://www.ncbr.gov.pl/

Funders

Funder type

Government

Funder name

Narodowe Centrum Badań i Rozwoju

Alternative name(s)

National Centre for Research and Development, NCBR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Poland

Results and Publications

Publication and dissemination plan

Publications in peer-reviewed journals, conference presentations.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: Ludmiła Zając-Lamparska (lzajac@ukw.edu.pl); Paweł Izdebski (pawel@ukw.edu.pl) and Monika Wiłkość-Dębczyńska (monikawilkosc@gmail.com) in two weeks after request via e-mail. They will be available for scientist and for use in meta-analyses and / or systematic reviews. The raw data and/ or descriptive statistics will be provided without personal data of study participants (only anonymous data or aggregated data). This is consistent with the informed consent was obtained from all individual participants included in the study (all subjects gave written informed consent in accordance with the Declaration of Helsinki; if the participants with mild dementia had a legal guardian, the legal guardian gave written informed consent in accordance with the Declaration of Helsinki).

Intention to publish date

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

2017 results in: https://www.semanticscholar.org/paper/Virtual-reality-in-cognitive-interventions-for-and-Zaj%C4%85c-Lamparska-Wi%C5%82ko%C5%9B%C4%87-D%C4%99bczy%C5%84ska/1105179af2a909383e7c160027069ded52bb2bd0 (added 30/08/2019)
2017 results in: https://www.termedia.pl/Effectiveness-of-GRADYS-a-cognitive-training-with-elements-of-virtual-reality-in-adults-older-than-60-and-without-cognitive-impairment,46,32144,0,1.html (added 30/08/2019)

Publication citations

Additional files

Editorial Notes

02/09/2019: Trial’s existence confirmed by Narodowe Centrum Badań i Rozwoju (National Centre for Research and Development)