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

NCT07254676 | Completed

• 2 other identifiers: UKC-MB-KME-36/21IRP-2021/02-08
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 goals of the study are:

1. 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. 2.To explore the relationship between cognitive impairment and upper limb motor recovery using VR.

Conditions

Acute Stroke Intervention; Rehabilitation Exercise

Keywords

virtual reality; stroke rehabilitation; upper limb; cognition; acute phase

Outcome Measures

Primary Outcomes (3)

• The Fugl-Meyer Upper Extremity Assessment (FMA-UE)

  Fugl-Meyer Upper Extremity Assessment (FMA-UE). Will evaluate post-stroke body functions-motor function, sensation, passive joint motion, and joint pain. Scoring will sum all item scores to a total of 0-126, with higher scores indicating better function.

  Change from baseline to 2 weeks (end of intervention)

• The Wolf Motor Function Test (WMFT)

  Wolf Motor Function Test (WMFT). Will assess upper-limb performance with 17 items (2 strength items and 15 timed tasks) that progress from proximal to distal/whole-limb movements. Outcomes will include task times and the Functional Ability Scale (FAS); the mean FAS will be computed as total FAS/15 (range 0-5).

  Change from baseline to 2 weeks (end of intervention)

• Grip strength

  Grip strength. Will be measured in kilograms using a calibrated hand dynamometer. Participants will perform three maximal efforts with the affected hand while seated (elbow 90°, forearm neutral); the best of three will be recorded for analysis.

  Change from baseline to 2 weeks (end of intervention)

Secondary Outcomes (3)

• 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)

• The Montreal Cognitive Assessment (MoCA)

  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 rehabilitation; Other: Conventional rehabilitation therapy (CRT)

CRT (Conventional rehabilitation therapy)

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation therapy (CRT)

Interventions

Virtual Reality-enhanced rehabilitation 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.

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.

Also known as: physiotherapy, occupational therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• University Medical Centre Maribor: lead

Study Sites (1)

University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia

Maribor, 2000, Slovenia

Location

Related Publications (6)

• Karamians R, Proffitt R, Kline D, Gauthier LV. Effectiveness of Virtual Reality- and Gaming-Based Interventions for Upper Extremity Rehabilitation Poststroke: A Meta-analysis. Arch Phys Med Rehabil. 2020 May;101(5):885-896. doi: 10.1016/j.apmr.2019.10.195. Epub 2019 Dec 7.

  PMID: 31821799 BACKGROUND

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

• Chen X, Liu F, Lin S, Yu L, Lin R. Effects of Virtual Reality Rehabilitation Training on Cognitive Function and Activities of Daily Living of Patients With Poststroke Cognitive Impairment: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2022 Jul;103(7):1422-1435. doi: 10.1016/j.apmr.2022.03.012. Epub 2022 Apr 10.

  PMID: 35417757 BACKGROUND

• Li J, Wang J, Wu B, Xu H, Wu X, Zhou L, Deng B. Association Between Early Cognitive Impairment and Midterm Functional Outcomes Among Chinese Acute Ischemic Stroke Patients: A Longitudinal Study. Front Neurol. 2020 Feb 26;11:20. doi: 10.3389/fneur.2020.00020. eCollection 2020.

  PMID: 32174878 BACKGROUND

• Kim WS, Cho S, Ku J, Kim Y, Lee K, Hwang HJ, Paik NJ. Clinical Application of Virtual Reality for Upper Limb Motor Rehabilitation in Stroke: Review of Technologies and Clinical Evidence. J Clin Med. 2020 Oct 21;9(10):3369. doi: 10.3390/jcm9103369.

  PMID: 33096678 BACKGROUND

• Gorsic M, Cikajlo I, Novak D. Competitive and cooperative arm rehabilitation games played by a patient and unimpaired person: effects on motivation and exercise intensity. J Neuroeng Rehabil. 2017 Mar 23;14(1):23. doi: 10.1186/s12984-017-0231-4.

  PMID: 28330504 BACKGROUND

Related Links

• research projects

MeSH Terms

Interventions

Physical Therapy Modalities; Occupational Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Tadeja Hernja Rumpf, MD, PhD

  University Medical Centre Maribor, Ljubljanska 5, 2000 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: May 5, 2022
• Primary Completion: September 10, 2024
• Study Completion: April 24, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)