NCT07381452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 24, 2026

Last Update Submit

February 9, 2026

Conditions

Acute Stroke InterventionRehabilitation ExerciseCognitive Assessment

Keywords

virtual realitystroke rehabilitationcognitionacute phase

Outcome Measures

Primary Outcomes (2)

  • The Mini-Mental State Examination (MMSE)

    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.

    Change from baseline to 2 weeks (end of intervention)

  • The Barthel Index (BI)

    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.

    Change from baseline to 2 weeks (end of intervention)

Secondary Outcomes (2)

  • The National Institutes of Health Stroke Scale (NIHSS)

    Change from baseline to 2 weeks (end of intervention)

  • The Modified Rankin Scale (mRS)

    Change from baseline to 2 weeks (end of intervention)

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Virtual reality-enhanced rehabilitationOther: Conventional rehabilitation therapy (CRT)

CRT (Conventional rehabilitation therapy)

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation therapy (CRT)

Interventions

Virtual reality-enhanced rehabilitationBEHAVIORAL

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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Severe cognitive impairment that precludes following instructions.
  • Aphasia or severe visual/hearing impairment that prevents meaningful participation.
  • End-stage/terminal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia

Maribor, 2000, Slovenia

Location

Related Links

Study Officials

  • Tadeja Hernja Rumpf

    University Medical Centre Maribor, Slovenia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Therapists who will evaluate participants with scales will be blinded to group allocation.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2026

First Posted

February 2, 2026

Study Start

May 5, 2024

Primary Completion

June 10, 2025

Study Completion

September 24, 2025

Last Updated

February 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to the small sample size and increased re-identification risk under GDPR. Aggregate results, study protocol, and statistical analysis plan will be made available upon publication.

Locations

SL(1)