An interventional study of Haptic-assisted virtual reality training (Bimeo PRO) and Conventional rehabilitation in Intracerebral Hemorrhage, Hemorrhagic Stroke and Paresis, sponsored by University Medical Centre Maribor. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University Medical Centre Maribor · Not applicable, Interventional, and Treatment
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.
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 178 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 286 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →University Medical Centre Maribor is the lead sponsor of 36 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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).
Device: Haptic-assisted virtual reality training (Bimeo PRO) · Other: Conventional rehabilitation
Conventional physiotherapy and occupational therapy only (10 sessions of 60 minutes over 2 weeks).
Other: Conventional rehabilitation
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.
Also known as: Bimeo PRO
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.
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.
Time frame: Baseline and after the 2-week intervention period
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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline and after the 2-week intervention period
Adherence to the rehabilitation programme
Number and proportion of planned sessions and planned VR minutes completed.
Time frame: During the 2-week intervention period
Tolerability
Proportion of sessions shortened or discontinued because of fatigue, pain, dizziness, discomfort or other intolerance.
Time frame: 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.
Time frame: During the 2-week intervention period
Plan to share: No — Due to legal restrictions.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.
Of 81 non-industry interventional studies with no phase under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 71. This study's planned 17 months is below that.
Counting every sponsor, half of 89 studies reached it within 38 months; a quarter within 19 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University Medical Centre Maribor