Post-stroke rehabilitation is essential for maximising motor recovery. Virtual reality (VR) is emerging as a promising adjunct to conventional therapy (CRT), potentially enhancing upper limb motor outcomes. The goals of the study are: 1. To evaluate the efficiency of VR in addition to CRT on upper limb function in the acute phase of post-stroke rehabilitation, which is underrepresented in the literature. 2. To explore the relationship between cognitive impairment and upper limb motor recovery using VR. The investigators hypothesise that combining VR and CRT improves upper limb functional outcomes in acute stroke beyond the effects of CRT.
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 in improving upper limb function in acute post-stroke patients. Participants will be randomly assigned to a two-week program of VR training combined with conventional therapy (experimental group) or conventional therapy alone (control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Dose of practice and difficulty: In each VR session, participants will perform three tasks, completing one trial of each-reaching, tracking, and labyrinth-with no within-session repetitions. Across ten sessions, participants will complete ten trials of each task (30 trials 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.
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.
University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia
Maribor, Slovenia
The Fugl-Meyer Upper Extremity Assessment (FMA-UE)
Fugl-Meyer Upper Extremity Assessment (FMA-UE). Will evaluate post-stroke body functions-motor function, sensation, passive joint motion, and joint pain. Scoring will sum all item scores to a total of 0-126, with higher scores indicating better function.
Time frame: Change from baseline to 2 weeks (end of intervention)
The Wolf Motor Function Test (WMFT)
Wolf Motor Function Test (WMFT). Will assess upper-limb performance with 17 items (2 strength items and 15 timed tasks) that progress from proximal to distal/whole-limb movements. Outcomes will include task times and the Functional Ability Scale (FAS); the mean FAS will be computed as total FAS/15 (range 0-5).
Time frame: Change from baseline to 2 weeks (end of intervention)
Grip strength
Grip strength. Will be measured in kilograms using a calibrated hand dynamometer. Participants will perform three maximal efforts with the affected hand while seated (elbow 90°, forearm neutral); the best of three will be recorded for analysis.
Time frame: Change from baseline to 2 weeks (end of intervention)
The National Institutes of Health Stroke Scale (NIHSS)
The NIHSS is a comprehensive assessment tool used to evaluate the severity of a stroke. The scale generates scores ranging from 0, denoting the absence of deficits, to 46, signifying severe impairment.
Time frame: 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.
Time frame: Change from baseline to 2 weeks (end of intervention)
The Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) serves as a cognitive screening instrument, encompassing the evaluation of visuospatial/executive function, naming, memory, attention, language, abstraction, recall, and orientation.
Time frame: Change from baseline to 2 weeks (end of intervention)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.