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

May 3, 2026 updated by: Tadeja Hernja Rumpf

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

  • Slovenia
      • Maribor, Slovenia, 2000
        • University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy)
The experimental group will receive 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), ten sessions over two weeks of 60 minutes per session and an additional 15 minutes of virtual-reality (VR) training per session using the Bimeo PRO system (Kinestica d.o.o., Slovenia) in a unimanual, two-dimensional configuration on a flat surface, with continuous therapist supervision.
Behavioral: Virtual reality-enhanced rehabilitation
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.
Other: Conventional rehabilitation therapy (CRT)
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.
Active Comparator: CRT (Conventional rehabilitation therapy)
The control group will receive 10 sessions over 2 weeks of physiotherapy and occupational therapy (manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training, such as moving an object horizontally across a surface), each lasting 60 minutes.
Other: Conventional rehabilitation therapy (CRT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 2 weeks (end of intervention)
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.
Change from baseline to 2 weeks (end of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline to 2 weeks (end of intervention)
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
Change from baseline to 2 weeks (end of intervention)

Collaborators and Investigators

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

Sponsor

Tadeja Hernja Rumpf

Investigators

  • Principal Investigator: Tadeja Hernja Rumpf, University Medical Centre Maribor, Slovenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

May 5, 2024

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

September 24, 2025

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

January 24, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UKC-MB-KME-3/24
  • IRP-2021/02-08 (Other Grant/Funding Number: UKC Maribor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to the small sample size and increased re-identification risk under GDPR. Aggregate results, study protocol, and statistical analysis plan will be made available upon publication.

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.

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