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

March 31, 2026 updated by: Universitas Padjadjaran

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Farida Arisanti, MD, PMR, Neurorehab
  • Phone Number: +6285351111946

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Immersive VR Cognitive Rehabilitation
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
Device: Immersive Virtual Reality System

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).
Active Comparator: Active Comparator: Conventional Cognitive Rehabilitation
Participants in this group (n=11) will receive standard cognitive rehabilitation using conventional paper-and-pencil tasks, in addition to standard stroke care.
Behavioral: Conventional Paper-and-Pencil Cognitive Training

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Post-Intervention (Week 8)
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
Baseline and Post-Intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Study Chair: Farida Arisanti, MD, PMR, Neurorehab, PMR Department, Faculty of Medicine - Universitas Padjadjaran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKFR-202603.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke (Subacute)

Clinical Trials on Immersive Virtual Reality System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe