Haptic-Assisted Virtual Reality Upper-Limb Rehabilitation After Intracerebral Haemorrhage

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.

• Haptic-assisted virtual reality training (Bimeo PRO) (Device), also known as 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 rehabilitation (Other): 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.

Primary outcomes

• Change in Fugl-Meyer Assessment - Upper Extremity (FMA-UE) motor score [Baseline and after the 2-week intervention period]: FMA-UE motor score, 0-66; higher scores indicate better upper-limb motor function.

Secondary outcomes

• Change in Wolf Motor Function Test (WMFT) [Baseline and after the 2-week intervention period]: WMFT performance time and functional ability scale (0-5 per task; higher functional ability scores indicate better function; shorter times indicate better performance).
• Change in grip strength [Baseline and after the 2-week intervention period]: Maximal grip strength of the affected hand measured with a hand-held dynamometer, in kilograms.
• Change in neurological deficit (NIHSS) [Baseline and after the 2-week intervention period]: National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit).
• Change in disability (modified Rankin Scale) [Baseline and after the 2-week intervention period]: mRS score (0 = no symptoms to 6 = death; higher scores indicate worse outcome).
• Adherence to the rehabilitation programme [During the 2-week intervention period]: Number and proportion of planned sessions and planned VR minutes completed.
• Tolerability [During the 2-week intervention period]: Proportion of sessions shortened or discontinued because of fatigue, pain, dizziness, discomfort or other intolerance.
• Adverse events [During the 2-week intervention period]: Number and type of adverse events and serious adverse events, including fatigue, transient pain, dizziness and falls.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

• Martin Rakuša, MD, PhD, Principal investigator, University Medical Centre Maribor