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NCT Number: NCT07506486

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

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

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Key information

Conditions

Stroke (Subacute) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders Stroke Vascular Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ani Purwati, MD

CONTACT

[email protected]

+62 852-2131-4160

Farida Arisanti, MD, PMR, Neurorehab

CONTACT

+6285351111946

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

Effect of Cognitive Rehabilitation Using Immersive Virtual Reality on Cognitive Function and Functional Activity of Subacute Stroke Patients: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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