Stroke (Subacute)NCT07506486
Effect of Immersive Virtual Reality Cognitive Rehabilitation on Subacute Stroke Patients (A Pilot Study)
A study testing Immersive Virtual Reality System and Conventional Paper-and-Pencil Cognitive Training in people with Stroke (Subacute), run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
This pilot randomized controlled trial aims to evaluate the effectiveness of cognitive rehabilitation using an immersive Virtual Reality (VR) system compared to conventional paper-and-pencil cognitive training in subacute stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Stroke (Subacute)
- What is being tested?
- Immersive Virtual Reality System and Conventional Paper-and-Pencil Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 40-59 years old
- Stroke patient 2-4 months onset of stroke
- Burnstorm stage V or above
- First-time stroke that has been diagnosed by a neurologist with CT scan and/or MRI
- Stroke risk factors and comorbidities are controlled with medication
- Mild and moderate level of cognitive impairment based on MOCA and can use devices
Show all 9Show fewer
- Participants can grip and operate VR console with their hand
- Participants can follow instructions and exercises
- Participants were cooperative and willing to participate in the study by signing a consent form after receiving an explanation.
Who cannot join
- Participants with severe cognitive impairment or aphasia struggle to understand instructions
- Neglected patient
- Participants with low vision unable to perceive content on screens
- Participant with eyestrain characterized by blurring vision, dry eyes, foreign body sensation, itching watering, neck stiffness and backache
- Severe musculoskeletal disorders causing problem in standing and following instruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Farida Arisanti, MD, PMR, Neurorehab contact
Indonesia1 site
RSUD Majalengka
Majalengka, West Java, 45411
Henny Luthfianingrum, MD, PMR, +628997282496, hennyluthfianingrum@gmail.com
About this study
Official title: Effect of Cognitive Rehabilitation Using Immersive Virtual Reality on Cognitive Function and Functional Activity of Subacute Stroke Patients: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial aims to evaluate the effectiveness of cognitive rehabilitation using an immersive Virtual Reality (VR) system compared to conventional paper-and-pencil cognitive training in subacute stroke patients. A total of 22 participants will be randomly assigned to either the VR intervention group (n=11) or the conventional control group (n=11). The study will measure changes in cognitive function and functional independence
Read the detailed description
Cognitive impairment is a common and debilitating consequence of stroke that hinders functional recovery. This pilot study investigates immersive Virtual Reality (VR) as a novel, engaging modality for cognitive rehabilitation in subacute stroke patients.
Twenty-two eligible subacute stroke patients treated at Dr. Hasan Sadikin General Hospital will be recruited and randomized into two parallel arms. The experimental group (n=11) will receive cognitive rehabilitation using an immersive VR system, while the active control group (n=11) will receive conventional cognitive rehabilitation using standardized paper-and-pencil tests. Both interventions will be administered alongside standard stroke rehabilitation care. Assessments will be conducted at baseline and post-intervention to evaluate cognitive improvement using the Indonesian version of the Montreal Cognitive Assessment (MoCA-INA) and functional activity using the Functional Independence Measure (FIM).
- Conditions
- Stroke (Subacute)
- Being tested
- Immersive Virtual Reality System, Conventional Paper-and-Pencil Cognitive Training
- Keywords
- cognitive impairment
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality SystemDevice
Intervention Description: Treatment Method: Participants will wear a fully immersive VR headset to engage in interactive, gamified virtual environments specifically designed to stimulate cognitive domains (memory, attention, visuospatial, and executive functions).
Duration \& Frequency: Each VR session will last for [30 to 45 minutes]. The treatment will be administered at a frequency of [3 sessions per week] for a total duration of [8 consecutive weeks].
Standard Care: This intervention is provided in addition to the hospital's standard conventional stroke rehabilitation program (e.g., standard physical therapy).
Conventional Paper-and-Pencil Cognitive TrainingBehavioural
Intervention Description: Treatment Method: Participants will perform standardized paper-and-pencil tasks, puzzles, and therapeutic worksheets guided by a therapist, targeting identical cognitive domains (memory, attention, visuospatial, and executive functions) as the experimental group.
Duration \& Frequency: Each conventional session will last for [30 to 45 minutes] to match the experimental arm. The treatment will be administered at a frequency of [3 sessions per week] for a total duration of [8 consecutive weeks].
Standard Care: This intervention is provided in addition to the hospital's standard conventional stroke rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Immersive VR Cognitive Rehabilitation | Experimental | articipants in this group (n=11) will receive cognitive rehabilitation sessions using an immersive Virtual Reality (VR) headset and software, in addition to standard stroke care Receives: Device: Immersive Virtual Reality System |
| Active Comparator: Conventional Cognitive Rehabilitation | Active comparator | Participants in this group (n=11) will receive standard cognitive rehabilitation using conventional paper-and-pencil tasks, in addition to standard stroke care. Receives: Behavioral: Conventional Paper-and-Pencil Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA)
The MoCA-INA assesses several cognitive domains including visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered normal.
Measured: Baseline and Post-Intervention (Week 8)
Change in Functional Activity Assessed by Functional Independence Measure (FIM)
The FIM is an 18-item measurement tool that explores an individual's physical, psychological, and social function. The tool assesses the level of independence a patient has in daily tasks. Total scores range from 18 to 126, with higher scores indicating a higher level of functional independence
Measured: Baseline and Post-Intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (Subacute)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farida Arisanti, MD, PMR, Neurorehab, Study chair, PMR Department, Faculty of Medicine - Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506486
- Sponsor's protocol ID
- IKFR-202603.02
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Rehabilitation Using Immersive Virtual Reality on Cognitive Function and Functional Activity of Subacute Stroke Patients: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07506486
- Acronym / sponsor ID
- IKFR-202603.02
- Conditions
- Stroke (Subacute)
- Keywords
- cognitive impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized controlled trial aims to evaluate the effectiveness of cognitive rehabilitation using an immersive Virtual Reality (VR) system compared to conventional paper-and-pencil cognitive training in subacute stroke patients. A total of 22 participants will be randomly assigned to either the VR intervention group (n=11) or the conventional control group (n=11). The study will measure changes in cognitive function and functional independence
Detailed description
Cognitive impairment is a common and debilitating consequence of stroke that hinders functional recovery. This pilot study investigates immersive Virtual Reality (VR) as a novel, engaging modality for cognitive rehabilitation in subacute stroke patients.
Twenty-two eligible subacute stroke patients treated at Dr. Hasan Sadikin General Hospital will be recruited and randomized into two parallel arms. The experimental group (n=11) will receive cognitive rehabilitation using an immersive VR system, while the active control group (n=11) will receive conventional cognitive rehabilitation using standardized paper-and-pencil tests. Both interventions will be administered alongside standard stroke rehabilitation care. Assessments will be conducted at baseline and post-intervention to evaluate cognitive improvement using the Indonesian version of the Montreal Cognitive Assessment (MoCA-INA) and functional activity using the Functional Independence Measure (FIM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Immersive VR Cognitive Rehabilitation | Experimental | Device: Immersive Virtual Reality Systemarticipants in this group (n=11) will receive cognitive rehabilitation sessions using an immersive Virtual Reality (VR) headset and software, in addition to standard stroke care |
| Active Comparator: Conventional Cognitive Rehabilitation | Active comparator | Behavioral: Conventional Paper-and-Pencil Cognitive TrainingParticipants in this group (n=11) will receive standard cognitive rehabilitation using conventional paper-and-pencil tasks, in addition to standard stroke care. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female aged 40-59 years old
- Stroke patient 2-4 months onset of stroke
- Burnstorm stage V or above
- First-time stroke that has been diagnosed by a neurologist with CT scan and/or MRI
- Stroke risk factors and comorbidities are controlled with medication
Key exclusion criteria (5 listed)
- Participants with severe cognitive impairment or aphasia struggle to understand instructions
- Neglected patient
- Participants with low vision unable to perceive content on screens
- Participant with eyestrain characterized by blurring vision, dry eyes, foreign body sensation, itching watering, neck stiffness and backache
- Severe musculoskeletal disorders causing problem in standing and following instruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality SystemIntervention Description: Treatment Method: Participants will wear a fully immersive VR headset to engage in interactive, gamified virtual environments specifically designed to stimulate cognitive domains (memory, attention, visuospatial, and executive functions). Duration \& Frequency: Each VR session will last for [30 to 45 minutes]. The treatment will be administered at a frequency of [3 sessions per week] for a total duration of [8 consecutive weeks]. Standard Care: This intervention is provided in addition to the hospital's standard conventional stroke rehabilitation program (e.g., standard physical therapy). | Device | Experimental: Immersive VR Cognitive Rehabilitation |
| Conventional Paper-and-Pencil Cognitive TrainingIntervention Description: Treatment Method: Participants will perform standardized paper-and-pencil tasks, puzzles, and therapeutic worksheets guided by a therapist, targeting identical cognitive domains (memory, attention, visuospatial, and executive functions) as the experimental group. Duration \& Frequency: Each conventional session will last for [30 to 45 minutes] to match the experimental arm. The treatment will be administered at a frequency of [3 sessions per week] for a total duration of [8 consecutive weeks]. Standard Care: This intervention is provided in addition to the hospital's standard conventional stroke rehabilitation program. | Behavioural | Active Comparator: Conventional Cognitive Rehabilitation |
Primary outcome
Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA)
Time frame: Baseline and Post-Intervention (Week 8)
The MoCA-INA assesses several cognitive domains including visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered normal.
Change in Functional Activity Assessed by Functional Independence Measure (FIM)
Time frame: Baseline and Post-Intervention (Week 8)
The FIM is an 18-item measurement tool that explores an individual's physical, psychological, and social function. The tool assesses the level of independence a patient has in daily tasks. Total scores range from 18 to 126, with higher scores indicating a higher level of functional independence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farida Arisanti, MD, PMR, Neurorehab contact
Farida Arisanti, MD, PMR, Neurorehab study chair
PMR Department, Faculty of Medicine - Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality System and Conventional Paper-and-Pencil Cognitive Training in people with Stroke (Subacute), run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ani Purwati, MD (+62 852-2131-4160, anipurwati21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA) (time frame: Baseline and Post-Intervention (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.