Virtual Reality and Neurostimulation for Early Stroke Rehabilitation

NCT06887231 | Recruiting

• 1 other identifier: 2280/2024
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is one of the leading causes of disability, leaving millions of individuals each year impaired with lasting motor and sensory impairments. In the subacute phase, which goes from the first week to 3 months post-stroke, the patient has the highest recovery, which could be boosted by proper technologies intended for the rehabilitation of the patients. The impairments that the patients experience are extremely heterogeneous and go from muscle weakness to spasticity of the paretic side of the body. Beyond motor deficits, stroke survivors also suffer from sensory impairment (they do not properly feel with the paretic side of their body), impaired body representation (misjudging the size, position, and movement of their affected limb), which can further hinder recovery. 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.

Conditions

Stroke

Keywords

Stroke; Virtual Reality; Transcutaneous Electrical Nerve Stimulation; Multisensory integration; Task oriented movement; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Changes in functional performances

  To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in sensorimotor impairments

  To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in upper limb body representation

  To measure the body representation of the subjects the investigators will use body-landmark metric. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) describing the proportion of patients' arm while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimension of patients' arm

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

Secondary Outcomes (10)

• Changes in degree of assistance required

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in spasticity at hand and elbow level

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in peripersonal space

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in tactile acuity

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Changes in spatial neglect (CBS)

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

Other Outcomes (2)

• Changes in pain

  day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

• Treatment Satisfaction

  3 weeks (one day after the last rehabilitation session, T2)

Study Arms (2)

VR+TENS

EXPERIMENTAL

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.

Other: VR+TENS

Conventional Rehabilitation

ACTIVE COMPARATOR

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.

Other: Conventional rehabilitation

Interventions

VR+TENS OTHER

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.

VR+TENS

Conventional rehabilitation OTHER

Patients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy.

Conventional Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of ischemic or hemorrhagic stroke
• 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

You may not qualify if:

• Other neurological or physical impairment or mental condition that, in the judgment of the investigator, does not allow participation in the study.
• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Neurology

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (21)

• 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.

  PMID: 1135616 BACKGROUND

• 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.

  PMID: 40886914 BACKGROUND

• 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.

  PMID: 37407726 BACKGROUND

• 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.

  PMID: 27080070 BACKGROUND

• 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.

  PMID: 30477527 BACKGROUND

• 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.

  PMID: 36959332 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 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.

  PMID: 30654899 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35590144 BACKGROUND

• 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.

  PMID: 35950092 BACKGROUND

• 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.

  PMID: 39532102 BACKGROUND

• 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.

  PMID: 32973612 BACKGROUND

• 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.

  PMID: 22792492 BACKGROUND

• 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.

  PMID: 20556766 BACKGROUND

• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

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• 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.

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• 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.

  PMID: 35027963 BACKGROUND

• 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.

  PMID: 33069326 BACKGROUND

• 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.

  PMID: 39417225 BACKGROUND

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  PMID: 17141640 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Andrea Cimolato, PhD

CONTACT

+4314040039224; andrea.cimolato@meduniwien.ac.at

Anna Sparapani, MSc

CONTACT

+4314040039224; anna.sparapani@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)