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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2025-04-24

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Stroke Intervention Rehabilitation Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Therapists who will evaluate participants with scales will be blinded to group allocation.

Study Groups

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

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.

Group Type EXPERIMENTAL

Virtual Reality-enhanced rehabilitation

Intervention Type BEHAVIORAL

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.

Conventional rehabilitation therapy (CRT)

Intervention Type OTHER

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.

CRT (Conventional rehabilitation therapy)

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.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation therapy (CRT)

Intervention Type OTHER

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.

Interventions

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Virtual Reality-enhanced rehabilitation

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.

Intervention Type BEHAVIORAL

Conventional rehabilitation therapy (CRT)

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.

Intervention Type OTHER

Other Intervention Names

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physiotherapy occupational therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No