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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immersive Virtual Reality System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Baseline and Post-Intervention (Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ani Purwati, MD | Contact | +62 852-2131-4160 | anipurwati21@gmail.com | |
| Farida Arisanti, MD, PMR, Neurorehab | Contact | +6285351111946 |
| Name | Affiliation | Role |
|---|---|---|
| Farida Arisanti, MD, PMR, Neurorehab | PMR Department, Faculty of Medicine - Universitas Padjadjaran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUD Majalengka | Majalengka | West Java | 45411 | Indonesia |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional Paper-and-Pencil Cognitive Training | Behavioral | 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. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |