StrokeVR-TENSNCT06887231
Virtual Reality and Neurostimulation for Early Stroke Rehabilitation
A study testing VR+TENS and Conventional rehabilitation in people with Stroke, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- VR+TENS and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- 17 Mar 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Department of Neurology
Vienna, State of Vienna, 1090
Bernhard Fasching, MSc, +43 40400 34540, bernhard.fasching@meduniwien.ac.at
About this study
Official title: Virtual Reality (VR) Platform and Transcutaneous Electrical Nerve Stimulation (TENS) for Early Stroke Rehabilitation
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.
Read more
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
- Being tested
- VR+TENS, Conventional rehabilitation
- Keywords
- Stroke, Virtual Reality, Transcutaneous Electrical Nerve Stimulation, Multisensory integration, Task oriented movement, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR+TENSOther
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 rehabilitationOther
Patients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
To assess the degree of assistance required by an individual on ten mobility and self-care the investigators will use the Barthel Index. The score goes from 0 to 100. It consists of an ordinal scale which measures a person's ability to complete activities of daily living (ADL)
Measured: 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
The investigators will use Modified Ashworth Scale to test resistance to passive movement about a joint with varying degrees of velocity. This test is performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met).
Measured: 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
To measure the peri-personal space of stroke patients (the space in which multisensory integration is enhanced). Test Performance: In VR, the subject is sitting on a table and sees balls approaching him. He/she's asked to press a controller whenever he/she feels electrical stimulation.
Measured: 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
To measure the tactile acuity of patients we will use the Two-Point discrimination test. While blindfolded, the patient is repetitively touched with either one or two pins (fixed distance) and he asked to tell how many pins he/she feels.
Measured: 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)
To measure spatial neglect, participants will be assessed using the Catherine Bergego Scale, which comprises 10 everyday tasks observed during self-care activities. A therapist scores the patient on behaviors such as neglecting the left side of the body and difficulties in grooming, eating, movement, and spatial awareness. The CBS uses a 4-point scale (0-3) to rate neglect severity, with a total score of 30.
Measured: 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 (LBT)
To measure spatial neglect, patients will perform a line bisection test. The Line Bisection Test is a test is a quick measure to detect the presence of unilateral spatial neglect (USN). To complete the test, one must place a mark with a pencil through the center of a series of horizontal lines. Usually, a displacement of the bisection mark towards the side of the brain lesion is interpreted as a symptom of neglect.
Measured: 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 kinematics (Velocity)
To assess changes in velocity the investigators will measure kinematic velocity of the patients while performing rehabilitation tasks.
Measured: Every day, from day 1 to day 14
Changes in upper limb kinematics (Smoothness)
To assess changes in smoothness the investigators will measure kinematic smoothness of the patients while performing rehabilitation tasks.
Measured: Every day, from day 1 to day 14
Changes in upper limb kinematics (Efficiency)
To assess changes in efficiency the investigators will measure the amount and rate of task-oriented movements of the patients.
Measured: Every day, from day 1 to day 14
Changes in upper limb kinematics (Precision)
To assess changes in precision the investigators will measure the spatial precision (error with respect to a predefined correct movement) during the task-oriented movements of the patient.
Measured: Every day, from day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Mar 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Stanisa Raspopovic, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887231
- Sponsor's protocol ID
- 2280/2024
- Acronym
- VR-TENS
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1135616G. V. Aurucci et al., 'Targeted neural stimulation congruent with immersive reality decreases neuropathic pain - a Randomized Controlled Trial', Dec. 11, 2024, medRxiv. doi: 10.1101/2024.12.10.24318374.
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.
PubMed 37407726Bolognini 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.
PubMed 27080070Perez-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.
PubMed 30477527Hao 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.
PubMed 36959332Laver 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.
PubMed 29156493Chen 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.
PubMed 30654899A. 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.
PubMed 35590144Bassolino 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.
PubMed 35950092Mastria 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.
PubMed 39532102Matamala-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.
PubMed 32973612Takeuchi 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.
PubMed 22792492Doyle 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.
PubMed 20556766
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality (VR) Platform and Transcutaneous Electrical Nerve Stimulation (TENS) for Early Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06887231
- Acronym / sponsor ID
- VR-TENS / 2280/2024
- Conditions
- Stroke
- Keywords
- Stroke, Virtual Reality, Transcutaneous Electrical Nerve Stimulation, Multisensory integration, Task oriented movement, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR+TENS | Experimental | Other: VR+TENSPatients 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. |
| Conventional Rehabilitation | Active comparator | Other: Conventional rehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR+TENSPatients 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. | Other | VR+TENS |
| Conventional rehabilitationPatients will perform dose-matched conventional rehabilitation (aligned with the intervention group), which will include physiotherapy, occupational therapy, and physical therapy. | Other | Conventional Rehabilitation |
Primary outcome
Changes in functional performances
Time frame: 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)
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.
Changes in sensorimotor impairments
Time frame: 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)
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.
Changes in upper limb body representation
Time frame: 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)
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
10 secondary outcomes
Changes in degree of assistance required
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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 (LBT)
Time frame: 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 kinematics (Velocity)
Time frame: Every day, from day 1 to day 14
Changes in upper limb kinematics (Smoothness)
Time frame: Every day, from day 1 to day 14
Changes in upper limb kinematics (Efficiency)
Time frame: Every day, from day 1 to day 14
Changes in upper limb kinematics (Precision)
Time frame: Every day, from day 1 to day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background: PubMed 1135616Fugl-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.
- BackgroundG. V. Aurucci et al., 'Targeted neural stimulation congruent with immersive reality decreases neuropathic pain - a Randomized Controlled Trial', Dec. 11, 2024, medRxiv. doi: 10.1101/2024.12.10.24318374.
- Background: PubMed 37407726Aurucci 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.
- Background: PubMed 27080070Bolognini 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.
- Background: PubMed 30477527Perez-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.
- Background: PubMed 36959332Hao 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.
- Background: PubMed 29156493Laver 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.
- Background: PubMed 30654899Chen 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.
- BackgroundA. 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: PubMed 35590144Crema 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.
- Background: PubMed 35950092Bassolino 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.
- Background: PubMed 39532102Mastria 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.
- Individual participant dataSharing planned: No
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR+TENS and Conventional rehabilitation in people with Stroke, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Cimolato, PhD (+4314040039224, andrea.cimolato@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in functional performances (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887231, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.