Acute Stroke InterventionVRNCT07254676
Virtual Reality-Enhanced Rehabilitation for Upper Limb Recovery in Acute Post-Stroke Patients
A study testing Virtual Reality-enhanced rehabilitation and Conventional rehabilitation therapy (CRT) in people with Acute Stroke Intervention and Rehabilitation Exercise, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke Intervention, Rehabilitation Exercise
- What is being tested?
- Virtual Reality-enhanced rehabilitation and Conventional rehabilitation therapy (CRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 May 2022to 24 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe cognitive impairment that precludes following instructions.
- Aphasia or severe visual/hearing impairment that prevents meaningful participation.
- End-stage/terminal illness.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia
Maribor, 2000
About this study
Official title: 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:
- 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.
- 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.
Read the 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).
- Conditions
- Acute Stroke Intervention, Rehabilitation Exercise
- Being tested
- Virtual Reality-enhanced rehabilitation, Conventional rehabilitation therapy (CRT)
- Keywords
- virtual reality, stroke rehabilitation, upper limb, cognition, acute phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-enhanced rehabilitationBehavioural
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.
Conventional rehabilitation therapy (CRT)Other
Also called physiotherapy, occupational therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) | Experimental | 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. Receives: Behavioral: Virtual Reality-enhanced rehabilitation; Other: Conventional rehabilitation therapy (CRT) |
| CRT (Conventional rehabilitation therapy) | Active comparator | 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. Receives: Other: Conventional rehabilitation therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
The Wolf Motor Function Test (WMFT)
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).
Measured: Change from baseline to 2 weeks (end of intervention)
Grip strength
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.
Measured: Change from baseline to 2 weeks (end of intervention)
Secondary outcomes (3)
The National Institutes of Health Stroke Scale (NIHSS)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
The Modified Rankin Scale (mRS)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
The Montreal Cognitive Assessment (MoCA)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start5 May 2022
- Primary completion10 Sep 2024
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Stroke InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomly allocated to the experimental group (VR training in addition to CRT) or the control group (only CRT) using sealed envelopes with group tasks in numerical sequence.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadeja Hernja Rumpf, University Medical Centre Maribor
- Investigators
- Tadeja Hernja Rumpf, MD, PhD, Principal investigator, University Medical Centre Maribor, Ljubljanska 5, 2000 Maribor, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254676
- Sponsor's protocol ID
- UKC-MB-KME-36/21
- Other IDs
- IRP-2021/02-08
- Acronym
- VR
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7.
PubMed 31821799Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
PubMed 29156493Chen X, Liu F, Lin S, Yu L, Lin R. Effects of Virtual Reality Rehabilitation Training on Cognitive Function and Activities of Daily Living of Patients With Poststroke Cognitive Impairment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2022 Jul;103(7):1422-1435. doi: 10.1016/j.apmr.2022.03.012. Epub 2022 Apr 10.
PubMed 35417757Li J, Wang J, Wu B, Xu H, Wu X, Zhou L, Deng B. Association Between Early Cognitive Impairment and Midterm Functional Outcomes Among Chinese Acute Ischemic Stroke Patients: A Longitudinal Study. Front Neurol. 2020 Feb 26;11:20. doi: 10.3389/fneur.2020.00020. eCollection 2020.
PubMed 32174878Kim WS, Cho S, Ku J, Kim Y, Lee K, Hwang HJ, Paik NJ. Clinical Application of Virtual Reality for Upper Limb Motor Rehabilitation in Stroke: Review of Technologies and Clinical Evidence. J Clin Med. 2020 Oct 21;9(10):3369. doi: 10.3390/jcm9103369.
PubMed 33096678Gorsic M, Cikajlo I, Novak D. Competitive and cooperative arm rehabilitation games played by a patient and unimpaired person: effects on motivation and exercise intensity. J Neuroeng Rehabil. 2017 Mar 23;14(1):23. doi: 10.1186/s12984-017-0231-4.
PubMed 28330504
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Enhanced Rehabilitation on Upper Limb Recovery in Acute Post-Stroke Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT07254676
- Acronym / sponsor ID
- VR / UKC-MB-KME-36/21
- Conditions
- Acute Stroke Intervention, Rehabilitation Exercise
- Keywords
- virtual reality, stroke rehabilitation, upper limb, cognition, acute phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to the experimental group (VR training in addition to CRT) or the control group (only CRT) using sealed envelopes with group tasks in numerical sequence.
| Arm | Type | Receives |
|---|---|---|
| VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) | Experimental | Behavioral: Virtual Reality-enhanced rehabilitation, Other: Conventional rehabilitation therapy (CRT)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. |
| CRT (Conventional rehabilitation therapy) | Active comparator | Other: Conventional rehabilitation therapy (CRT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe cognitive impairment that precludes following instructions.
- Aphasia or severe visual/hearing impairment that prevents meaningful participation.
- End-stage/terminal illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-enhanced rehabilitationDose 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. | Behavioural | VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) |
| Conventional rehabilitation therapy (CRT)Also: physiotherapy, occupational therapyPhysiotherapy 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 | CRT (Conventional rehabilitation therapy), VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) |
Primary outcome
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.
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).
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.
3 secondary outcomes
The National Institutes of Health Stroke Scale (NIHSS)
Time frame: 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 Montreal Cognitive Assessment (MoCA)
Time frame: Change from baseline to 2 weeks (end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 31821799Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7.
- Background: PubMed 29156493Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
- Background: PubMed 35417757Chen X, Liu F, Lin S, Yu L, Lin R. Effects of Virtual Reality Rehabilitation Training on Cognitive Function and Activities of Daily Living of Patients With Poststroke Cognitive Impairment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2022 Jul;103(7):1422-1435. doi: 10.1016/j.apmr.2022.03.012. Epub 2022 Apr 10.
- Background: PubMed 32174878Li J, Wang J, Wu B, Xu H, Wu X, Zhou L, Deng B. Association Between Early Cognitive Impairment and Midterm Functional Outcomes Among Chinese Acute Ischemic Stroke Patients: A Longitudinal Study. Front Neurol. 2020 Feb 26;11:20. doi: 10.3389/fneur.2020.00020. eCollection 2020.
- Background: PubMed 33096678Kim WS, Cho S, Ku J, Kim Y, Lee K, Hwang HJ, Paik NJ. Clinical Application of Virtual Reality for Upper Limb Motor Rehabilitation in Stroke: Review of Technologies and Clinical Evidence. J Clin Med. 2020 Oct 21;9(10):3369. doi: 10.3390/jcm9103369.
- Background: PubMed 28330504Gorsic M, Cikajlo I, Novak D. Competitive and cooperative arm rehabilitation games played by a patient and unimpaired person: effects on motivation and exercise intensity. J Neuroeng Rehabil. 2017 Mar 23;14(1):23. doi: 10.1186/s12984-017-0231-4.
- research projectsLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Acute Stroke Intervention
Recruiting
Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions
Acute Ischemic Stroke
Recruiting
Efficacy of a Telehealth Delivered Group Lifestyle Balance for People Post Stroke (tGLB-CVA)
Stroke, Acute, Stroke
Recruiting
Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring
Acute Ischemic Stroke, Cerebral Autoregulation
Recruiting
A Comparison of Cyclic Manual Direct Aspiration Thrombectomy (Plunger Technique) vs. Static Manual Direct Aspiration Thrombectomy for Treatment of Acute Large Vessel Occlusion Stroke
Acute Ischemic Stroke Patients, Large Vessel Occlusion
RecruitingObservational study
Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Stroke, Stroke, Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadeja Hernja Rumpf, MD, PhD principal investigator
University Medical Centre Maribor, Ljubljanska 5, 2000 Maribor, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-enhanced rehabilitation and Conventional rehabilitation therapy (CRT) in people with Acute Stroke Intervention and Rehabilitation Exercise, run by University Medical Centre Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fugl-Meyer Upper Extremity Assessment (FMA-UE) (time frame: Change from baseline to 2 weeks (end of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254676, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.