Acute Stroke Intervention, Cognitive Assessment, Rehabilitation Exercise
Conditions
Keywords
virtual reality, stroke rehabilitation, cognition, acute phase
Brief summary
Post-stroke rehabilitation is essential for maximising the recovery of cognitive function. Virtual reality (VR) has emerged as a promising adjunct to conventional rehabilitation therapy (CRT), with the potential to enhance cognitive performance outcomes. This study aims to evaluate the effects of VR-based rehabilitation compared with CRT on cognitive function and activities of daily living in patients with acute stroke.
Detailed description
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 on cognitive function and activities of daily living in patients with acute stroke. Participants will be randomly assigned to a two-week VR training program combined with conventional therapy (experimental group) or to conventional therapy alone (control group).
Interventions
BEHAVIORALVirtual reality-enhanced rehabilitation
Dose of practice and difficulty: In each VR session, participants will perform two tasks, completing one trial of each-a memory task and a meal-preparation task -with no within-session repetitions. Over ten sessions, participants will complete 10 trials of each task (30 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.
Sponsors
Tadeja Hernja Rumpf
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Therapists who will evaluate participants with scales will be blinded to group allocation.
Intervention model description
Participants will be randomly allocated to the experimental group (VR training in addition to CRT) or the control group (only CRT) using sealed envelopes with group tasks in numerical sequence.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18 years. * First-ever acute stroke, occurring \<7 days before therapy start * Cognitive impairment on admission (Mini-Mental State Examination score \< 24 * Ability to understand and perform virtual reality (VR) tasks.
Exclusion criteria
* Severe cognitive impairment that precludes following instructions. * Aphasia or severe visual/hearing impairment that prevents meaningful participation. * End-stage/terminal illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mini-Mental State Examination (MMSE) | Change from baseline to 2 weeks (end of intervention) | It is a widely used screening tool for global cognitive function. It evaluates orientation, immediate registration and short-term recall, attention and calculation, and language and praxis. The total score ranges from 0 to 30, and scores below 24 are commonly interpreted as suggestive of cognitive impairment. |
| The Barthel Index (BI) | Change from baseline to 2 weeks (end of intervention) | The Barthel Index (BI) evaluates an individual's level of independence and mobility in activities of daily living (ADLs), including feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, walking/ambulation, and stair climbing. It also helps determine the degree of assistance required for care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The National Institutes of Health Stroke Scale (NIHSS) | Change from baseline to 2 weeks (end of intervention) | The NIHSS is a comprehensive assessment tool used to evaluate stroke severity. The scale generates scores ranging from 0 (denoting the absence of deficits) to 46 (signifying severe impairment). |
| The Modified Rankin Scale (mRS) | Change from baseline to 2 weeks (end of intervention) | 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 |
Countries
Slovenia
Contacts
PRINCIPAL_INVESTIGATORTadeja Hernja Rumpf
University Medical Centre Maribor, Slovenia
Outcome results
None listed