Intracerebral HemorrhageCR-4-Health-VRNCT07882810
Haptic-Assisted Virtual Reality Upper-Limb Rehabilitation After Intracerebral Haemorrhage
A study testing Haptic-assisted virtual reality training (Bimeo PRO) and Conventional rehabilitation in people with Intracerebral Hemorrhage and Hemorrhagic Stroke, run by University Medical Centre Maribor at 3 sites in 2 countries.
Trial summary
After spontaneous intracerebral haemorrhage (ICH), many survivors have persistent weakness of the arm and hand. Virtual reality (VR) training with haptic (force-feedback) devices may support upper-limb recovery, but evidence comes mainly from ischaemic or mixed stroke populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Hemorrhagic Stroke, Paresis
- What is being tested?
- Haptic-assisted virtual reality training (Bimeo PRO) and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2026to 30 Apr 2028
- Phase
- Interventional
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
- Participant in the CrossReg-4-Health cohort (age 18 years or older, acute spontaneous non-traumatic intracerebral haemorrhage confirmed by non-contrast CT or MRI)
- Residual upper-limb motor impairment
- Clinical stability
- Ability to participate safely in exercise
- Written informed consent for the substudy from the patient or a legally authorised representative
Who cannot join
- Intracerebral haemorrhage secondary to head trauma, intracranial neoplasm, isolated subarachnoid haemorrhage or another primary type of intracranial haemorrhage
- End-of-life care decision
- Withdrawal of consent or major protocol violation
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Austria2 sites
LKH-Universitätsklinikum Graz, Medical University of Graz
Graz, 8036
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Slovenia1 site
University Medical Centre Maribor, Department of Neurology
Maribor, 2000
About this study
Official title: Feasibility and Preliminary Efficacy of Haptic-Assisted Virtual Reality Rehabilitation for Upper-Limb Motor Impairment After Spontaneous Intracerebral Haemorrhage: An Exploratory Substudy of the CrossReg-4-Health Cohort
After spontaneous intracerebral haemorrhage (ICH), many survivors have persistent weakness of the arm and hand. Virtual reality (VR) training with haptic (force-feedback) devices may support upper-limb recovery, but evidence comes mainly from ischaemic or mixed stroke populations.
This exploratory substudy of the CrossReg-4-Health cohort will include 100 adults with upper-limb motor impairment after ICH. All participants will receive conventional physiotherapy and occupational therapy (ten 60-minute sessions over two weeks). Half will additionally receive 15 minutes of supervised haptic-assisted VR training per session using the Bimeo PRO system. Upper-limb motor function, disability, adherence, tolerability and adverse events will be assessed before and after the two-week programme to estimate feasibility and preliminary effect sizes for future trials.
Read the detailed description
This is an exploratory interventional substudy embedded in the CrossReg-4-Health prospective multicentre cohort of patients with spontaneous intracerebral haemorrhage (registered separately on ClinicalTrials.gov), conducted within the Interreg Slovenia-Austria project CrossReg-4-Health (grant SIAT00307).
Participants: 100 cohort participants with residual upper-limb motor impairment who are clinically stable and able to participate safely in exercise; separate written consent is obtained for the substudy.
Interventions: Both groups receive standard physiotherapy and occupational therapy, including manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation and task-specific upper-limb training, delivered as 10 sessions of 60 minutes over 2 weeks. The intervention group additionally receives 15 minutes of supervised VR training per session with the Bimeo PRO system (Kinestica d.o.o., Slovenia) in a unimanual two-dimensional configuration on a flat surface, comprising three task-oriented exercises (reaching, tracking, labyrinth navigation) at fixed difficulty, for a total additional dose of 150 minutes. Frequency, duration, number of sessions, adherence and adverse events are recorded.
Allocation: Participants are allocated to the two groups without randomisation. Upper-limb outcome assessments are performed by an assessor blinded to group allocation.
Assessments are performed at baseline and after the two-week intervention period. Between-group differences in FMA-UE, WMFT and grip strength will be estimated with baseline-adjusted regression models and reported with 95% confidence intervals. Feasibility, adherence, tolerability and adverse events will be summarised descriptively. The substudy is not powered for definitive efficacy; results are hypothesis-generating and will inform the design of future trials.
- Conditions
- Intracerebral Hemorrhage, Hemorrhagic Stroke, Paresis
- Being tested
- Haptic-assisted virtual reality training (Bimeo PRO), Conventional rehabilitation
- Keywords
- virtual reality, haptic device, Bimeo, upper limb rehabilitation, Fugl-Meyer, intracerebral haemorrhage, stroke rehabilitation
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haptic-assisted virtual reality training (Bimeo PRO)Device
Also called Bimeo PRO
Supervised 15-minute VR sessions with the Bimeo PRO haptic system (Kinestica d.o.o., Slovenia) in a unimanual two-dimensional configuration on a flat surface, consisting of reaching, tracking and labyrinth navigation tasks at fixed difficulty; delivered in each of 10 sessions over 2 weeks.
Conventional rehabilitationOther
Standard physiotherapy and occupational therapy including manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation and task-specific upper-limb training; 10 sessions of 60 minutes over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Conventional rehabilitation plus haptic-assisted VR | Experimental | Conventional physiotherapy and occupational therapy (10 sessions of 60 minutes over 2 weeks) plus 15 minutes of supervised haptic-assisted virtual reality training per session with the Bimeo PRO system (total additional dose 150 minutes). Receives: Device: Haptic-assisted virtual reality training (Bimeo PRO); Other: Conventional rehabilitation |
| Conventional rehabilitation | Active comparator | Conventional physiotherapy and occupational therapy only (10 sessions of 60 minutes over 2 weeks). Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment - Upper Extremity (FMA-UE) motor score
FMA-UE motor score, 0-66; higher scores indicate better upper-limb motor function.
Measured: Baseline and after the 2-week intervention period
Secondary outcomes (7)
Change in Wolf Motor Function Test (WMFT)
WMFT performance time and functional ability scale (0-5 per task; higher functional ability scores indicate better function; shorter times indicate better performance).
Measured: Baseline and after the 2-week intervention period
Change in grip strength
Maximal grip strength of the affected hand measured with a hand-held dynamometer, in kilograms.
Measured: Baseline and after the 2-week intervention period
Change in neurological deficit (NIHSS)
National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit).
Measured: Baseline and after the 2-week intervention period
Change in disability (modified Rankin Scale)
mRS score (0 = no symptoms to 6 = death; higher scores indicate worse outcome).
Measured: Baseline and after the 2-week intervention period
Adherence to the rehabilitation programme
Number and proportion of planned sessions and planned VR minutes completed.
Measured: During the 2-week intervention period
Tolerability
Proportion of sessions shortened or discontinued because of fatigue, pain, dizziness, discomfort or other intolerance.
Measured: During the 2-week intervention period
Adverse events
Number and type of adverse events and serious adverse events, including fatigue, transient pain, dizziness and falls.
Measured: During the 2-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, Klinikum Klagenfurt am Wörthersee
- Responsible party
- Sponsor
- Investigators
- Martin Rakuša, MD, PhD, Principal investigator, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882810
- Sponsor's protocol ID
- CrossReg-4-Health-VR
- Other IDs
- SIAT00307
- Acronym
- CR-4-Health-VR
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to legal restrictions.