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Not yet recruiting NCT07506486

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

No phase Interventional Stroke (Subacute)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immersive Virtual Reality System, Conventional Paper-and-Pencil Cognitive Training.
Who it may be relevant to
Registry conditions: Stroke (Subacute). Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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).

Interventions

  • 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
  • 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 durat

Primary outcome measures

  • Change in Cognitive Function Assessed by Montreal Cognitive Assessment - Indonesian Version (MoCA-INA) [Time frame: Baseline and Post-Intervention (Week 8)]
  • Change in Functional Activity Assessed by Functional Independence Measure (FIM) [Time frame: Baseline and Post-Intervention (Week 8)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • RSUD Majalengka — Majalengka

Identifiers

NCT: NCT07506486 · IKFR-202603.02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗