CR-4-Health-VRNCT07882810

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

StatusNot Yet Recruiting

PhaseNot applicable

SponsorUniversity Medical Centre Maribor

Primary completionApr 30, 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 12, 2026 Study First Submitted

Endpoints

Primary

Change in Fugl-Meyer Assessment - Upper Extremity (FMA-UE) motor score

Timeframe: Baseline and after the 2-week intervention period

Secondary (7)

Change in Wolf Motor Function Test (WMFT)

Change in grip strength

Change in neurological deficit (NIHSS)

Change in disability (modified Rankin Scale)

Adherence to the rehabilitation programme

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Tolerability

Adverse events

Arms and interventions

Conventional rehabilitation plus haptic-assisted VRExperimental

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).

Conventional rehabilitationActive comparator

Conventional physiotherapy and occupational therapy only (10 sessions of 60 minutes over 2 weeks).

Devices: Haptic-assisted virtual reality training (Bimeo PRO)

Other: Conventional rehabilitation

Sites

3 sites in 2 countries

Austria 2, Slovenia 1

About this trial

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.

Trial details

Enrollment: 100 participants (estimated)
Started: Nov 1, 2026
Study completion: Apr 30, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, non-randomized, single blind, treatment
Oversight: Data monitoring committee
Conditions: Cerebral Hemorrhage, Hemorrhagic Stroke, Paresis, Intracerebral Hemorrhage
Collaborators: Medical University of Graz, Klinikum Klagenfurt am Wörthersee
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
First posted: Oct 20, 2026
Registry updated: Oct 20, 2026
Last verified: Oct 2026

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