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Completed

NCT Number: NCT07381452

Virtual Reality-Enhanced Rehabilitation for Cognitive Recovery in Acute Post-Stroke Patients: Pilot Study

Post-stroke rehabilitation is essential for maximising the recovery of cognitive function. Virtual reality (VR) has emerged as a promising adjunct to conventional rehabilitation therapy (CRT), with the potential to enhance cognitive performance outcomes. This study aims to evaluate the effects of VR-based rehabilitation compared with CRT on cognitive function and activities of daily living in patients with acute stroke.

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Key information

Conditions

Acute Stroke Intervention Cognitive Assessment Rehabilitation Exercise

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia

Maribor, 2000, Slovenia

About this study

The investigators will conduct a prospective randomised single- blind pilot controlled trial to evaluate the efficacy of VR-based rehabilitation with the Bimeo PRO system on cognitive function and activities of daily living in patients with acute stroke. Participants will be randomly assigned to a two-week VR training program combined with conventional therapy (experimental group) or to conventional therapy alone (control group).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥18 years.
  • First-ever acute stroke, occurring <7 days before therapy start
  • Cognitive impairment on admission (Mini-Mental State Examination score < 24
  • Ability to understand and perform virtual reality (VR) tasks.

Exclusion criteria

  • Severe cognitive impairment that precludes following instructions.
  • Aphasia or severe visual/hearing impairment that prevents meaningful participation.
  • End-stage/terminal illness.

Treatment and study plan

Virtual Reality-enhanced rehabilitation

Behavioral

Dose of practice and difficulty: In each VR session, participants will perform two tasks, completing one trial of each-a memory task and a meal-preparation task -with no within-session repetitions. Over ten sessions, participants will complete 10 trials of each task (30 in total). Task difficulty will be fixed and identical for all participants throughout the intervention (no automatic progression or therapist-driven difficulty changes). Adherence, tolerability, and adverse events: Participants will be scheduled to complete the prescribed VR dose (10 sessions; 150 minutes total). Adherence will be recorded at each session. Serious adverse events are not expected; all adverse events will be actively monitored and documented.

Conventional rehabilitation therapy (CRT)

Other

Physiotherapy and occupational therapy: manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training, such as horizontally moving an object across a surface, 60 minutes per session.

Primary outcomes

  1. The Mini-Mental State Examination (MMSE)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    It is a widely used screening tool for global cognitive function. It evaluates orientation, immediate registration and short-term recall, attention and calculation, and language and praxis. The total score ranges from 0 to 30, and scores below 24 are commonly interpreted as suggestive of cognitive impairment.

  2. The Barthel Index (BI)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The Barthel Index (BI) evaluates an individual's level of independence and mobility in activities of daily living (ADLs), including feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, walking/ambulation, and stair climbing. It also helps determine the degree of assistance required for care.

Secondary outcomes

  1. The National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The NIHSS is a comprehensive assessment tool used to evaluate stroke severity. The scale generates scores ranging from 0 (denoting the absence of deficits) to 46 (signifying severe impairment).

  2. The Modified Rankin Scale (mRS)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The Modified Rankin Scale (mRS) is a widely utilised and reliable functional assessment tool in clinical trials for stroke patients. Deviating from task-specific evaluations, the mRS measures the level of independence on a scale of 0 to 6

Sponsors and collaborators

Lead sponsor

Tadeja Hernja Rumpf

Other

Registry information

Official study title

Effects of Virtual Reality-Enhanced Rehabilitation on Cognitive Recovery in Acute Post-Stroke Patients: a Pilot Study

Acronym: VR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
May 7, 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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