Acute Stroke InterventionVRNCT07381452
Virtual Reality-Enhanced Rehabilitation for Cognitive Recovery in Acute Post-Stroke Patients: Pilot Study
A study testing Virtual reality-enhanced rehabilitation and Conventional rehabilitation therapy (CRT) in people with Acute Stroke Intervention and Rehabilitation Exercise, run by Tadeja Hernja Rumpf at 1 site in Slovenia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke Intervention, Rehabilitation Exercise, Cognitive Assessment
- 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
- 36 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 May 2024to 24 Sep 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
- Cognitive impairment on admission (Mini-Mental State Examination score < 24
- Ability to understand and perform virtual reality (VR) tasks.
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 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.
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 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).
- Being tested
- Virtual reality-enhanced rehabilitation, Conventional rehabilitation therapy (CRT)
- Keywords
- virtual reality, stroke rehabilitation, 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 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.
| 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 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. Receives: Other: Conventional rehabilitation therapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini-Mental State Examination (MMSE)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
The Barthel Index (BI)
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.
Measured: Change from baseline to 2 weeks (end of intervention)
Secondary outcomes (2)
The National Institutes of Health Stroke Scale (NIHSS)
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).
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start5 May 2024
- Primary completion10 Jun 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tadeja Hernja Rumpf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tadeja Hernja Rumpf, University Medical Centre Maribor
- Investigators
- Tadeja Hernja Rumpf, Principal investigator, University Medical Centre Maribor, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381452
- Sponsor's protocol ID
- UKC-MB-KME-3/24
- Other IDs
- IRP-2021/02-08
- Acronym
- VR
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 7 May 2026
- 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 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality-Enhanced Rehabilitation on Cognitive Recovery in Acute Post-Stroke Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT07381452
- Acronym / sponsor ID
- VR / UKC-MB-KME-3/24
- Keywords
- virtual reality, stroke rehabilitation, cognition, acute phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tadeja Hernja RumpfUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 2 Feb 2026 (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 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.
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 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 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. |
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
- Cognitive impairment on admission (Mini-Mental State Examination score < 24
- Ability to understand and perform virtual reality (VR) tasks.
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 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. | Behavioural | VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) |
| 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 | CRT (Conventional rehabilitation therapy), VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy) |
Primary outcome
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.
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.
2 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)
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 7 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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 principal investigator
University Medical Centre 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 Tadeja Hernja Rumpf 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 7 May 2026. 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 Mini-Mental State Examination (MMSE) (time frame: Change from baseline to 2 weeks (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.