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

NCT07506486 | Not Yet Recruiting

• 1 other identifier: IKFR-202603.02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Stroke (Subacute)

Keywords

cognitive impairment

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

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

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.

Behavioral: Conventional Paper-and-Pencil Cognitive Training

Interventions

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).

Experimental: Immersive VR Cognitive Rehabilitation

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.

Active Comparator: Conventional Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

RSUD Majalengka

Majalengka, West Java, 45411, Indonesia

Location

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Ani Purwati, MD

CONTACT

+62 852-2131-4160; anipurwati21@gmail.com

Farida Arisanti, MD, PMR, Neurorehab Consultant

CONTACT

+6285351111946

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 15, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

ID (1)