Virtual Reality-Enhanced Rehabilitation for Upper Limb Recovery in Acute Post-Stroke Patients (VR)

University Medical Centre Maribor

Status: Completed

Conditions: Acute Stroke Intervention; Rehabilitation Exercise

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07254676

UKC-MB-KME-36/21

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

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 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.

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 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).

Enrollment: 52 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.
• Upper-limb activity limitation with some preserved function (e.g., ability to grasp).
• Able to understand instructions and provide informed consent.

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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52 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:

Behavioral: Virtual Reality-enhanced rehabilitation

Other: Conventional rehabilitation therapy (CRT)

CRT (Conventional rehabilitation therapy)

Active Comparator group

Description:

The control group will receive ten sessions over two weeks of 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.

Treatment:

Other: Conventional rehabilitation therapy (CRT)