Virtual Reality-Enhanced Rehabilitation for Cognitive Recovery in Acute Post-Stroke Patients: Pilot Study (VR)

University Medical Centre Maribor

Status: Completed

Conditions: Cognitive Assessment; Acute Stroke Intervention; Rehabilitation Exercise

Treatments: Behavioral: Virtual reality-enhanced rehabilitation; Other: Conventional rehabilitation therapy (CRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07381452

IRP-2021/02-08 (Other Grant/Funding Number)

UKC-MB-KME-3/24

Details and patient eligibility

About

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 goal of the study is to investigate the impact of virtual reality rehabilitation compared to conventional rehabilitation therapy on cognitive function and activities of daily living in patients with acute stroke.

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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36 participants in 2 patient groups

VR + CRT (Virtual reality-enhanced rehabilitation plus Conventional rehabilitation therapy)

Experimental group

Description:

The experimental group will receive 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), ten sessions over two weeks of 60 minutes per session and an additional 15 minutes of virtual-reality (VR) training per session using the Bimeo PRO system (Kinestica d.o.o., Slovenia) in a unimanual, two-dimensional configuration on a flat surface, with continuous therapist supervision.

Treatment:

Other: Conventional rehabilitation therapy (CRT)

Behavioral: Virtual reality-enhanced rehabilitation

CRT (Conventional rehabilitation therapy)

Active Comparator group

Description:

The control group will receive 10 sessions over 2 weeks of physiotherapy and occupational therapy (manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training, such as moving an object horizontally across a surface), each lasting 60 minutes.

Treatment:

Other: Conventional rehabilitation therapy (CRT)