Virtual Reality and Neurostimulation for Early Stroke Rehabilitation
NCT ID: NCT06887231
Last Updated: 2025-04-06
Study Results
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Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2025-03-17
2027-01-31
Brief Summary
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Traditional rehabilitation primarily targets motor function, often without considering at all the role of sensory feedback and body perception in the recovery process. However, growing evidence suggests that the combination of multiple sensory modalities towards a multifaceted rehabilitation can enhance neuroplasticity and improve rehabilitation outcomes.
To address this, the investigators have developed a novel rehabilitation approach that integrates immersive virtual reality (VR) with transcutaneous electrical nerve stimulation (TENS). This system allows stroke patients to interact with a virtual environment while receiving synchronized tactile stimulation, reinforcing sensorimotor integration. Unlike conventional therapy, which relies on passive or repetitive exercises, this approach engages patients in active, goal-oriented movements, tailored to their individual recovery progress.
By focusing on the subacute stroke population, this project aims to leverage the brain's heightened plasticity during early recovery to maximize functional improvements. The VR-based intervention will adapt to each patient's motor abilities, providing real-time feedback to encourage precise movements and enhance sensory processing. Through this multisensory experience, the investigators seek to improve not only motor control but also sensory and body representation measures.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VR+TENS
Patients will engage in goal-directed upper-limb rehabilitation exercises within a virtual reality environment. During these exercises, they will receive synchronized electrical stimulation targeting the median nerve.
The intervention phase will span three weeks, with patients participating in at least three sessions per week, each lasting approximately 60 minutes.
VR+TENS
Patients will perform task-oriented movements in an immersive scenario while receiving congruent electrical stimulation. During each session, multiple games will be played, with the type and difficulty calibrated based on the patient's level of impairment.
Conventional Rehabilitation
Participants will undergo the same therapy duration, engaging in conventional physiotherapy, occupational therapy, or physical therapy. Exercises and movements will be designed to align with those in the experimental group.
Conventional rehabilitation
Patients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy.
Interventions
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VR+TENS
Patients will perform task-oriented movements in an immersive scenario while receiving congruent electrical stimulation. During each session, multiple games will be played, with the type and difficulty calibrated based on the patient's level of impairment.
Conventional rehabilitation
Patients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy.
Eligibility Criteria
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Inclusion Criteria
* In the subacute phase (from 7 days to 3 months from last stroke onset)
* Fugl-Meyer-Upper Extremity (FMUE) scale for the motor part: FMUE ≥ 10
* Ability to sit in an upright position
* Age between 18 and 80 years
Exclusion Criteria
* Mini-Mental State Examination (MMSE) \< 24
* Epilepsy
* Nausea, headaches or fatigue due to VR-generated environment ("virtual reality motion sickness")
* Peripheral nerve damage in the affected arm or hand
* Pacemaker or other electronic implants
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Prof. Stanisa Raspopovic
Professor
Locations
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Medical University of Vienna, Department of Neurology
Vienna, Vienna, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
Aurucci GV, Gozzi N, Wagner M, Preatoni G, Brunello N, Cimolato A, Secerovic N, Zipser CM, Raspopovic S. Targeted neural stimulation congruent with immersive reality decreases neuropathic pain. Brain Stimul. 2025 Sep-Oct;18(5):1671-1674. doi: 10.1016/j.brs.2025.08.023. Epub 2025 Aug 29. No abstract available.
Aurucci GV, Preatoni G, Damiani A, Raspopovic S. Brain-Computer Interface to Deliver Individualized Multisensory Intervention for Neuropathic Pain. Neurotherapeutics. 2023 Sep;20(5):1316-1329. doi: 10.1007/s13311-023-01396-y. Epub 2023 Jul 5.
Bolognini N, Russo C, Edwards DJ. The sensory side of post-stroke motor rehabilitation. Restor Neurol Neurosci. 2016 Apr 11;34(4):571-86. doi: 10.3233/RNN-150606.
Perez-Marcos D. Virtual reality experiences, embodiment, videogames and their dimensions in neurorehabilitation. J Neuroeng Rehabil. 2018 Nov 26;15(1):113. doi: 10.1186/s12984-018-0461-0.
Hao J, He Z, Yu X, Remis A. Comparison of immersive and non-immersive virtual reality for upper extremity functional recovery in patients with stroke: a systematic review and network meta-analysis. Neurol Sci. 2023 Aug;44(8):2679-2697. doi: 10.1007/s10072-023-06742-8. Epub 2023 Mar 23.
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.
Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11.
A. Serino et al., 'Peripersonal Space: An Index of Multisensory Body-Environment Interactions in Real, Virtual, and Mixed Realities', Front. ICT, vol. 4, Jan. 2018, doi: 10.3389/fict.2017.00031.
Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.
Bassolino M, Franza M, Guanziroli E, Sorrentino G, Canzoneri E, Colombo M, Crema A, Bertoni T, Mastria G, Vissani M, Sokolov AA, Micera S, Molteni F, Blanke O, Serino A. Body and peripersonal space representations in chronic stroke patients with upper limb motor deficits. Brain Commun. 2022 Aug 5;4(4):fcac179. doi: 10.1093/braincomms/fcac179. eCollection 2022.
Mastria G, Bertoni T, Perrin H, Akulenko N, Risso G, Akselrod M, Guanziroli E, Molteni F, Hagmann P, Bassolino M, Serino A. Body ownership alterations in stroke emerge from reduced proprioceptive precision and damage to the frontoparietal network. Med. 2025 Apr 11;6(4):100536. doi: 10.1016/j.medj.2024.10.013. Epub 2024 Nov 11.
Matamala-Gomez M, Malighetti C, Cipresso P, Pedroli E, Realdon O, Mantovani F, Riva G. Changing Body Representation Through Full Body Ownership Illusions Might Foster Motor Rehabilitation Outcome in Patients With Stroke. Front Psychol. 2020 Aug 21;11:1962. doi: 10.3389/fpsyg.2020.01962. eCollection 2020.
Takeuchi N, Izumi S. Maladaptive plasticity for motor recovery after stroke: mechanisms and approaches. Neural Plast. 2012;2012:359728. doi: 10.1155/2012/359728. Epub 2012 Jun 26.
Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
Lucas-Noll J, Clua-Espuny JL, Lleixa-Fortuno M, Gavalda-Espelta E, Queralt-Tomas L, Panisello-Tafalla A, Carles-Lavila M. The costs associated with stroke care continuum: a systematic review. Health Econ Rev. 2023 May 17;13(1):32. doi: 10.1186/s13561-023-00439-6.
Strilciuc S, Grad DA, Radu C, Chira D, Stan A, Ungureanu M, Gheorghe A, Muresanu FD. The economic burden of stroke: a systematic review of cost of illness studies. J Med Life. 2021 Sep-Oct;14(5):606-619. doi: 10.25122/jml-2021-0361.
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
He Q, Wang W, Zhang Y, Xiong Y, Tao C, Ma L, Ma J, You C, Wang C. Global, Regional, and National Burden of Stroke, 1990-2021: A Systematic Analysis for Global Burden of Disease 2021. Stroke. 2024 Dec;55(12):2815-2824. doi: 10.1161/STROKEAHA.124.048033. Epub 2024 Oct 17.
Lang CE, Wagner JM, Dromerick AW, Edwards DF. Measurement of upper-extremity function early after stroke: properties of the action research arm test. Arch Phys Med Rehabil. 2006 Dec;87(12):1605-10. doi: 10.1016/j.apmr.2006.09.003.
Other Identifiers
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2280/2024
Identifier Type: -
Identifier Source: org_study_id
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