GRADYS – computer simulation software with virtual reality elements for enhancement of cognitive functions in the elderly with healthy aging and with dementia diseases
| ISRCTN | ISRCTN17613444 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17613444 |
| Secondary identifying numbers | IS-1/004/NCBR/2014 |
- Submission date
- 29/08/2019
- Registration date
- 10/09/2019
- Last edited
- 07/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Kazimierz Wielki University Institute of Psychology
ul. Staffa 1
Bydgoszcz
85-867
Poland
 ORCID ID |
0000-0003-4618-547X |
|---|---|
| Phone | +48604251762 |
| lzajac@ukw.edu.pl |
Study information
| Study design | Non randomised interventional pretest-posttest study design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant 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. |
| 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 |
| Study acronym | GRADYS |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 28/03/2013 |
| Completion date | 30/09/2016 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 99 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2015 |
| Date of final enrolment | 01/08/2016 |
Locations
Countries of recruitment
- Poland
Study participating centres
Bydgoszcz
85-064
Poland
Bydgoszcz
85-067
Poland
Swarzędz
62-020
Poland
Warszawa
01-043
Poland
Sponsor information
Government
Narodowe Centrum Badań i Rozwoju
Nowogrodzka 47a
Warszawa
00-695
Poland
| Phone | +48 22 390 74 01 |
|---|---|
| sekretariat@ncbr.gov.pl | |
| Website | https://www.ncbr.gov.pl/ |
"ROR" |
https://ror.org/05pwfyy15 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Centre for Research and Development, The National Centre for Research and Development, Polish National Center for Research and Development, National Center for Research & Development, NCBR, NCBiR, NCRD
- Location
- Poland
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications in peer-reviewed journals, conference presentations. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/10/2017 | 30/08/2019 | Yes | No |
| Results article | results | 01/01/2017 | 30/08/2019 | Yes | No |
| Results article | results | 27/11/2019 | 02/12/2019 | Yes | No |
Editorial Notes
07/11/2023: Internal review.
02/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
02/09/2019: Trial’s existence confirmed by Narodowe Centrum Badań i Rozwoju (National Centre for Research and Development)
