Virtual Reality-Enhanced Rehabilitation for Upper Limb Recovery in Acute Post-Stroke Patients (VR)

November 27, 2025 updated by: Tadeja Hernja Rumpf, University Medical Centre Maribor

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

Post-stroke rehabilitation is essential for maximising motor recovery. Virtual reality (VR) is emerging as a promising adjunct to conventional therapy (CRT), potentially enhancing upper limb motor outcomes. The goals of the study are:

  1. To evaluate the efficiency of VR in addition to CRT on upper limb function in the acute phase of post-stroke rehabilitation, which is underrepresented in the literature.
  2. To explore the relationship between cognitive impairment and upper limb motor recovery using VR.

The investigators hypothesise that combining VR and CRT improves upper limb functional outcomes in acute stroke beyond the effects of CRT.

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 in improving upper limb function in acute post-stroke patients. Participants will be randomly assigned to a two-week program of VR training combined with conventional therapy (experimental group) or conventional therapy alone (control group).

Study Type

Interventional

Enrollment (Actual)

52

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.
  • Upper-limb activity limitation with some preserved function (e.g., ability to grasp).
  • Able to understand instructions and provide informed consent.

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 three tasks, completing one trial of each-reaching, tracking, and labyrinth-with no within-session repetitions. Across ten sessions, participants will complete ten trials of each task (30 trials 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.
Other Names:
  • physiotherapy
  • occupational therapy
Active Comparator: CRT (Conventional rehabilitation therapy)
The control group will receive ten sessions over two weeks of 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.
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.
Other Names:
  • physiotherapy
  • occupational therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Time Frame: Change from baseline to 2 weeks (end of intervention)
Fugl-Meyer Upper Extremity Assessment (FMA-UE). Will evaluate post-stroke body functions-motor function, sensation, passive joint motion, and joint pain. Scoring will sum all item scores to a total of 0-126, with higher scores indicating better function.
Change from baseline to 2 weeks (end of intervention)
The Wolf Motor Function Test (WMFT)
Time Frame: Change from baseline to 2 weeks (end of intervention)
Wolf Motor Function Test (WMFT). Will assess upper-limb performance with 17 items (2 strength items and 15 timed tasks) that progress from proximal to distal/whole-limb movements. Outcomes will include task times and the Functional Ability Scale (FAS); the mean FAS will be computed as total FAS/15 (range 0-5).
Change from baseline to 2 weeks (end of intervention)
Grip strength
Time Frame: Change from baseline to 2 weeks (end of intervention)
Grip strength. Will be measured in kilograms using a calibrated hand dynamometer. Participants will perform three maximal efforts with the affected hand while seated (elbow 90°, forearm neutral); the best of three will be recorded for analysis.
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 the severity of a stroke. 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)
The Montreal Cognitive Assessment (MoCA)
Time Frame: Change from baseline to 2 weeks (end of intervention)
The Montreal Cognitive Assessment (MoCA) serves as a cognitive screening instrument, encompassing the evaluation of visuospatial/executive function, naming, memory, attention, language, abstraction, recall, and orientation.
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

University Medical Centre Maribor

Investigators

  • Principal Investigator: Tadeja Hernja Rumpf, MD, PhD, University Medical Centre Maribor, Ljubljanska 5, 2000 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.

General Publications

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, 2022

Primary Completion (Actual)

September 10, 2024

Study Completion (Actual)

April 24, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKC-MB-KME-36/21
  • 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 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

product manufactured in and exported from the U.S.

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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