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Not yet recruitingNCT07506486Updated Apr 6, 2026

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

An interventional study of Immersive Virtual Reality System and Conventional Paper-and-Pencil Cognitive Training in Stroke (Subacute), sponsored by Universitas Padjadjaran. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • Stroke (Subacute)

Keywords

  • cognitive impairment
03

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
22 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceImmersive 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).

  • BehavioralConventional 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.

05

What researchers measure

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)

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07506486
Lead sponsor
Universitas Padjadjaran
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
Apr 15, 2026 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Apr 6, 2026

Study contacts

Ani Purwati, MD
Contact
anipurwati21@gmail.com
+62 852-2131-4160
Farida Arisanti, MD, PMR, Neurorehab
Contact
+6285351111946
Farida Arisanti, MD, PMR, Neurorehab
study chair · PMR Department, Faculty of Medicine - Universitas Padjadjaran

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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