Effect of Immersive Virtual Reality Cognitive Rehabilitation on Subacute Stroke Patients (A Pilot Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversitas Padjadjaran

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Experimental: Immersive VR Cognitive RehabilitationExperimental treatment 1 intervention
Group B: Active Comparator: Conventional Cognitive RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and Post-Intervention (Week 8)
2

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

Time frame
Baseline and Post-Intervention (Week 8)

Secondary outcomes

Other outcomes

Sponsors and contacts

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