Cognitive rehabilitation using immersive virtual reality in stroke patients
| ISRCTN | ISRCTN14922230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14922230 |
| Secondary identifying numbers | S-MIP-23-137 |
- Submission date
- 22/12/2023
- Registration date
- 03/01/2024
- Last edited
- 04/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Stroke is one of the most common causes of death and long-term disability in the entire world. Post-stroke patients suffer not only motor impairments but also cognitive function deterioration. It is important to look into ways that could improve the rehabilitation of stroke patients. The aims of this study are:
1. To test the feasibility and effectiveness of short-term visual memory training tasks in immersive virtual reality in stroke patients;
2. To test the effect of these tasks on emotional state and motor functions in stroke patients.
Who can participate?
Stroke patients aged 18 to 85 years
What does the study involve?
The participants are randomly allocated to three groups: the experimental group (who, during the conventional rehabilitation program, participate in short-term visual memory training in immersive virtual reality); the active control group (who, during the conventional rehabilitation program, participate in short-term visual memory training in non-immersive virtual reality) and the passive control group (who participate in a conventional rehabilitation program).
What are the possible benefits and risks of participating?
Participants can benefit from participation in this study expecting to improve their cognitive functions and have the opportunity to try innovative methods. Participating in the study also is associated with possible risks such as dizziness, and cybersickness which are related to immersive virtual reality, even the tasks were created in order to avoid these symptoms.
Where is the study run from?
Vytautas Magnus University (Lithuania)
When is the study starting and how long is it expected to run for?
February 2022 to October 2025
Who is funding the study?
Lietuvos Mokslo Taryba (Research Council of Lithuania)
Who is the main contact?
Jovita Janavičiūtė-Pužauske, jovita.janaviciute-puzauske@vdu.lt
Contact information
Public, Scientific, Principal Investigator
Jonavos g. 66
Kaunas
44138
Lithuania
 ORCID ID |
0000-0001-7021-5806 |
|---|---|
| Phone | +370 63682100 |
| jovita.janaviciute-puzauske@vdu.lt |
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | The potential of cognitive rehabilitation in immersive virtual reality on near and far transfer effects in stroke patients |
| Study hypothesis | 1. Stroke patients who enroll in conventional rehabilitation and short-term visual memory training in immersive virtual reality improve cognitive functions and emotional state more than stroke patients who enroll just in conventional rehabilitation; 2. Stroke patients who enroll in conventional rehabilitation and short-term visual memory training in immersive virtual reality improve cognitive functions and emotional state more than stroke patients who enroll in conventional rehabilitation and short-term visual memory training in non-immersive virtual reality; 3. Stroke patients who enroll in conventional rehabilitation and short-term visual memory training in non-immersive virtual reality improve cognitive functions and emotional state more than stroke patients who enroll in conventional rehabilitation; |
| Ethics approval(s) |
Approved 15/02/2022, Vilnius Regional Biomedical Research Ethics Committee (M. K. Čiurlionio g. 21, Vilnius, LT-03101, Lithuania; +370 614 26126; rbtek@mf.vu.lt), ref: 2022/2-1408-880 |
| Condition | Cognitive function improvement in post-stroke patients |
| Intervention | All stroke patients who agree to participate complete pre-assessment and post-assessment. After the consent, they will be randomly allocated into one of the three groups. The randomization will be made each time rolling the dice (1-2 numbers mean participants randomly allocated to the passive control group; 3-4 numbers - active control group; and 5-6 numbers - experimental group). The pre-assessment includes the collection of demographic and clinical information. Demographic information includes sex, education, residence and the dominant hand. Clinical information included the type of stroke, its localization, the stroke stage, the use of medications, and leading diseases. Furthermore, questions about adverse symptoms (e.g. dizziness, cybersickness, air tightness, visual or coordination impairments, etc.) were included during the intervention. All participants completed pre-assessment and post-assessment. Patients in the experimental group participate in short-term visual memory training in immersive virtual reality and conventional rehabilitation. Patients in the active control group participate in short-term visual memory training in non-immersive virtual reality and conventional rehabilitation. Patients in the passive control group participate in conventional rehabilitation. The system of immersive virtual reality tasks in this study consists of two components: 1. An app installed on the Oculus Quest 2 head-mounted display (HMD) and 2. A tablet where a researcher can see the broadcasted view of the tasks. The two tasks were created based on four stages which are proposed by (Cordoso et al., 2017) 1. The initial development stage 2. The program construction 3. The program testing 4. The final development stage Sixteen experts (one neurologist, 3 physical medicine and rehabilitation physicians, 3 health psychologists, 4 occupational therapists, 3 physiotherapists, and 2 Doctors of Psychology) were asked to perform tasks in immersive VR and fill in the evaluation form. During the evaluation of validity, three aspects were assessed: 1. Suitability of the procedure 2. Suitability of the first task 3. Suitability of the second task. The content validity index showed that the procedure, the first task, and the second task were suitable for stroke patients. The first task is about recalling the cooking ingredients that are shown for the exact amount of time. The second task is about recalling the sequence of the cooking ingredients. Patients in the experimental group complete the tasks in immersive virtual reality using head-mounted display and the active control group complete these tasks using a tablet. The tasks in both settings are identical. Additionally, participants in the experimental or active control group attend ten 30-minute sessions (five times per week for two weeks) of short-term visual memory training. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Short-term visual memory is assessed using The Medical College of Georgia Complex Figures (MCGCF), forms A and B, during pre-assessment and post-assessment. 2. General cognitive functions and five domains (attention, memory, verbal fluency, language and visuospatial abilities) Addenbrooke's Cognitive Examination III forms A and B during pre-assessment and post-assessment. 3. Visual search, working memory, and executive functions are measured using the Trail Making tests Part A and Part B during pre-assessment and post-assessment. 4. Memory and learning are assessed using The Mnemonic Similarity Task C and D parts during pre-assessment and post-assessment. |
| Secondary outcome measures | 1. Depression symptoms are measured using The Patient Health Questionnaire – 9 at pre-assessment and post-assessment. 2. Anxiety symptoms are measured using The Generalized Anxiety Disorder scale - 7 at pre-assessment and post-assessment. 3. Psychomotor functions are measured using The Finger Tapping Test at pre-assessment and post-assessment. The several questionnaires additionally include during the post-assessment of experimental and active control groups: 4. The sense of presence in a virtual environment is measured using The Igroup Presence Questionnaire (IPQ) at post-assessment. 5. The system's usability is measured using The System Usability Scale (SUS) at post-assessment. |
| Overall study start date | 15/02/2022 |
| Overall study end date | 01/10/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 156 |
| Participant inclusion criteria | 1. Confirmed diagnosis of stroke 2. No severe cognitive impairment (fully understand the purpose and terms of the study) 3. The native language is Lithuanian 4. At least 3 days after the arrival at the rehabilitation center 5. Being able to sit |
| Participant exclusion criteria | 1. To be over the age of 85 years 2. To have epilepsy 3. To have such a degree of aphasia that a patient cannot understand spoken instructions and cannot answer meaningfully 4. To have the psychiatric diagnoses established 5. To experience unilateral neglect 6. To be characterized by severe motor disorders that restrict movements of both hands 7. To have other communication impairments that may prevent the patient from understanding task instructions or the purpose of the study |
| Recruitment start date | 01/03/2022 |
| Recruitment end date | 30/09/2025 |
Locations
Countries of recruitment
- Lithuania
Study participating centre
Abromiškės
LT-26130
Lithuania
Sponsor information
University/education
Jonavog g. 66
Kaunas
44138
Lithuania
| Phone | +370 37 327 947 |
|---|---|
| pka@smf.vdu.lt | |
| Website | http://www.vdu.lt/en/ |
"ROR" |
https://ror.org/04y7eh037 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Research Council of Lithuania, LIETUVOS MOKSLO TARYBA - Lithuania, Lietuvos mokslo taryba., LMT
- Location
- Lithuania
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal on pilot study and general findings. |
| IPD sharing plan | The datasets generated during the current study will be available on request. Also, the datasets generated during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 02/01/2024 | No | No | ||
| Statistical Analysis Plan | 02/01/2024 | No | No |
Additional files
Editorial Notes
04/10/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2024 to 30/09/2025.
2. The overall end date was changed from 01/10/2024 to 01/10/2025.
3. The plain English summary was updated to reflect these changes.
02/01/2024: Trial's existence confirmed by Vilnius Regional Biomedical Research Ethics Committee.
