Spinal Cord InjuryNCT07870044
Investigating Techniques to Enhance the Sense of Embodiment in Immersive Virtual Reality
A study testing Immersive Virtual Reality Embodiment Manipulations in people with Spinal Cord Injury and Stroke, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
Embodiment is an important aspect of virtual reality because it affects how natural and engaging the experience feels and can influence performance and learning in VR-based applications, including rehabilitation [McAnally \& Wallis, 2022]. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Stroke, Healthy
- What is being tested?
- Immersive Virtual Reality Embodiment Manipulations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2026to Aug 2028
- Phase
- Interventional
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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 12 to 50 years
- Typically developing participants (healthy volunteers) OR participants with spinal cord injury OR participants with history of stroke
- Score ≥ 7 on the "Vocabulary" subtest of WISC (for minors) or WAIS (for adults)
Who cannot join
- History of epilepsy or epileptic seizures
- Poor head control
- Visual acuity not correctable with glasses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Eugenio Medea
Bosisio Parini, Lecco, 23842
Emilia Biffi, PhD Eng, +39 031877862, emilia.biffi@lanostrafamiglia.it
Giorgia Malerba, PhD Candidate, +39 031 877645, giorgia.malerba@lanostrafamiglia.it
About this study
Official title: Studio Dell'Embodiment In Ambienti Di Realtà Virtuale Immersiva
Embodiment is an important aspect of virtual reality because it affects how natural and engaging the experience feels and can influence performance and learning in VR-based applications, including rehabilitation [McAnally \& Wallis, 2022]. In VR, embodiment refers to the extent to which a person feels that a virtual body (avatar) is their own and under their control. It is typically described as having three components: sense of agency (feeling that one is causing the avatar's actions), body ownership (feeling that the avatar's body is one's own), and self-location (feeling located where the avatar is) [Kilteni, Groten, \& Slater, 2012]. While many VR systems aim to increase embodiment, there is limited evidence on which specific techniques are most effective-especially in people with acquired neurological injuries, in whom central nervous system damage may alter body perception and multisensory integration [Guy, Normand, Jeunet-Kelway, \& Moreau, 2023].
This study will compare several VR techniques that may enhance embodiment, including synchronized visual and tactile stimulation, heart-rate-based visual biofeedback, increased possibilities to actively control the avatar, and familiarity with the performed action. Participants will include healthy volunteers and individuals with acquired neurological injuries (spinal cord injury or stroke). Across three study days, participants will complete multiple short VR conditions while wearing physiological sensors, and after each VR condition, participants will complete questionnaires about their VR experience. The goal is to identify which VR techniques most effectively increase embodiment and whether embodiment-related responses differ between healthy participants and clinical groups.
Read the detailed description
This is a prospective, single-center, non-profit interventional study conducted at IRCCS Eugenio Medea (Bosisio Parini, Italy) in collaboration with CNR-STIIMA. The aim is to investigate factors that influence embodiment during immersive virtual reality (VR), in healthy volunteers and in individuals with acquired neurological injuries (spinal cord injury or stroke). The study evaluates the effects of: (1) visuo-tactile stimulation, (2) VR biofeedback synchronized with the participant's heart rate, (3) the degree of active control over the avatar and virtual environment, and (4) familiarity with the performed action.
Each participant completes three experimental days. On Day 1, participants experience multiple short VR conditions, including a baseline condition (no additional stimulation), visuo-tactile stimulation, heart-rate-synchronized biofeedback, and active hand control of the avatar using motion tracking and data gloves. After each condition, participants perform a brief reaction-time task used in the literature as an objective, performance-based measure related to embodiment [Haggard, 2017; Scandola et al., 2019]: brief light stimuli are presented either on the avatar's body or in the surrounding virtual environment, and participants respond as quickly as possible when a light appears. Reaction times to body versus environment stimuli are compared, and the task is repeated after each condition to examine whether performance changes depending on the preceding VR experience.
On Day 2, participants complete immersive VR cycling tasks designed to probe sense of agency and body ownership by manipulating the match between visual feedback and the participant's actual movements (matched vs mismatched feedback) and by comparing active versus passive movement conditions. During Day 2, electroencephalography (EEG) is recorded to investigate neural correlates associated with embodiment and agency under the different VR manipulations [Estevers et al., 2025].
On Day 3, participants complete first-person VR mobility scenarios (walking or wheelchair) to evaluate embodiment in relation to task familiarity, comparing passive versus active exploration, with and without heart-rate-synchronized biofeedback.
Across all study days, participants wear wearable sensors to record electrodermal activity (EDA) [Hägni et al, 2008; Giangualano et al, 2025], cardiac activity for heart rate variability (HRV) [Ronca et al, 2024; Marìn-Morales, 2021; Hassard 2022] , and skin temperature [Salomon et al, 2013; Crivelli et al, 2021], providing objective physiological measures that may vary with embodiment-related experiences. After each condition on each study day, participants also complete the Virtual Embodiment Questionnaire (VEQ) [Roth \& Latoschik, 2020)].
Planned analyses will compare experimental conditions and participant groups (within each study day) using both subjective outcomes (VEQ scores) and objective measures (reaction-time task performance, physiological signals, and EEG metrics).
- Conditions
- Spinal Cord Injury, Stroke, Healthy
- Being tested
- Immersive Virtual Reality Embodiment Manipulations
- Keywords
- embodiment, virtual reality, Sense of agency, body ownership, Self-location, virtual avatar
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality Embodiment ManipulationsBehavioural
Participants undergo multiple immersive virtual reality conditions designed to modulate embodiment. Conditions include synchronized visuo-tactile stimulation, heart-rate-synchronized visual biofeedback, varying degrees of active control of the avatar, and tasks with different levels of familiarity. Conditions are presented as short VR scenarios across three study days, with randomized order within each day.
| Study group | Role | What they receive |
|---|---|---|
| Immersive VR Embodiment Conditions (Within-Subject) | Experimental | Participants complete multiple immersive virtual reality conditions across three study days. Conditions manipulate factors expected to influence embodiment. The order of conditions is randomized within each study day. Subjective embodiment is assessed after each condition using questionnaire, together with objective physiological measures. Receives: Behavioral: Immersive Virtual Reality Embodiment Manipulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Embodiment Questionnaire (VEQ) Subscale Scores (Ownership, Agency, Perceived Change in Body Representation)
Embodiment-related self-report assessed with the Virtual Embodiment Questionnaire (VEQ). Three subscale scores are computed: Ownership, Agency, and Perceived Change in Body Representation. Each subscale score is calculated as the mean of 4 items rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Higher scores indicate stronger perceived ownership of the virtual body (Ownership), greater sense of control over the virtual body/actions (Agency), and stronger perceived change in body representation during VR (Perceived Change in Body Representation).
Measured: Immediately after each VR condition on Day 1, Day 2, and Day 3.
Secondary outcomes (5)
Virtual Environment Light Test: Mean Reaction Time by Body vs Environment Locations
Participants perform a VR reaction-time task in which brief light stimuli are presented at predefined locations: on the avatar's right upper limb, left upper limb, right lower limb, left lower limb, or in the virtual environment outside the avatar. Stimuli occur at randomized intervals (1-5 seconds). Participants respond as quickly as possible when a light appears. The outcome is the mean reaction time (milliseconds) computed separately for each stimulus location category. Location-specific averages are used to capture potential asymmetries relevant to the clinical groups (e.g., right/left differences in stroke due to hemiparesis, and upper vs lower limb differences in spinal cord injury due to predominant lower-limb impairment).
Measured: Immediately after each VR condition on Day 1.
Electrodermal Activity (EDA) during VR conditions
Electrodermal activity (EDA), a measure of sympathetic arousal, includes a tonic component (skin conductance level, SCL) and a phasic component (skin conductance responses, SCR). EDA is recorded during the VR sessions. For each VR condition, EDA metrics are computed relative to the baseline. The tonic component is summarized as the mean SCL during the condition. Phasic activity is summarized by SCR measures, including the number of SCR peaks and the mean SCR peak amplitude during the condition. Baseline-referenced values are computed as change from baseline for each metric.
Measured: During each VR condition (60 seconds on Day 1 and Day 3; 120 seconds on Day 2)
Skin Temperature During Virtual Reality Conditions
Chest skin temperature will be analyzed as a slow physiological indicator that may vary with embodiment-related experiences in VR; based on prior findings, decreases in peripheral skin temperature have been reported with stronger embodiment. For each VR condition, skin temperature will be summarized as the mean value and condition values will be expressed relative to the baseline period (change from baseline).
Measured: During each VR condition (60 seconds on Day 1 and Day 3; 120 seconds on Day 2)
Heart Rate Variability (HRV) From ECG During VR Conditions
Electrocardiogram (ECG) is recorded continuously during each study session; on Day 1 and Day 3, the ECG-derived heart rate is also used to provide real-time heart-rate visual biofeedback in VR. R-peaks are detected to derive the RR-interval time series, with artifact beat correction prior to analysis. Heart rate variability (HRV) is quantified for each VR condition and compared with baseline. Planned HRV metrics include standard time-domain indices (e.g., mean RR, SDNN, RMSSD) and frequency-domain indices (e.g., LF and HF power and LF/HF ratio). In the literature, HRV frequency components have been reported as sensitive to embodiment-related manipulations, with higher LF activity associated with lower embodiment and higher HF activity associated with moderate/high embodiment.
Measured: During each VR condition (60 seconds on Day 1 and Day 3; 120 seconds on Day 2)
EEG Spectral Power and Derived Cognitive Indices During VR Cycling Tasks (Day 2)
Electroencephalography (EEG) is recorded during the second study day using the eego mylab system with a 32-channel cap. EEG data will be pre-processed and analyzed in MATLAB using EEGLAB and custom scripts to remove artifacts and restrict the frequency content to the bands of interest. Power spectral density is computed and summarized within standard EEG bands (Delta, Theta, Alpha, and Beta). From band-power features, indices reflecting cognitive state are derived. For each VR condition, EEG-derived indices are compared with the preceding resting baseline segment to quantify condition-related deviations. In prior VR research, spectral features-particularly in the alpha and beta bands, including spatio-spectral patterns-have been investigated as potential correlates of embodiment-related processes.
Measured: During each VR condition on Day 2 (120 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Feb 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant completes three study days in a fixed sequence. Within each day, participants complete multiple VR conditions with the order randomized to minimize order effects.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Responsible party
- Sponsor
- Investigators
- Emilia Biffi, PhD Eng, Principal investigator, IRCCS Eugenio Medea (Associazione La Nostra Famiglia)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870044
- Sponsor's protocol ID
- 189-24
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McAnally K, Wallis G. Visual-haptic integration, action and embodiment in virtual reality. Psychol Res. 2022 Sep;86(6):1847-1857. doi: 10.1007/s00426-021-01613-3. Epub 2021 Oct 28.
PubMed 34709463Guy, M., Normand, J. M., Jeunet-Kelway, C., & Moreau, G. (2023). The sense of embodiment in virtual reality and its assessment methods. Frontiers in Virtual Reality, 4, 1141683.
Kilteni, K., Groten, R., & Slater, M. (2012). The sense of embodiment in virtual reality. Presence: Teleoperators and Virtual Environments, 21(4), 373-387.
Giangualano, A., Boffi, P., Osimo, S. A., Yavari, M., Gabbiadini, A., Lanzi, P. L., & Gallace, A. (2025, October). Embodiment in Nature: How Avatar Choice Shapes an Underwater Virtual Reality Experience. In 2025 IEEE International Conference on Metrology for eXtended Reality, Artificial Intelligence and Neural Engineering (MetroXRAINE) (pp. 506-511). IEEE.
Esteves D, Valente M, Bendor SE, Andrade A, Vourvopoulos A. Identifying EEG biomarkers of sense of embodiment in virtual reality: insights from spatio-spectral features. Front Neuroergon. 2025 May 12;6:1572851. doi: 10.3389/fnrgo.2025.1572851. eCollection 2025.
PubMed 40420994HASSARD, A. (2023). The Sense of Embodiment in Virtual Reality Explored Through Presence, Narrative Immersion and Physical Effort.
Marin-Morales J, Higuera-Trujillo JL, Guixeres J, Llinares C, Alcaniz M, Valenza G. Heart rate variability analysis for the assessment of immersive emotional arousal using virtual reality: Comparing real and virtual scenarios. PLoS One. 2021 Jul 1;16(7):e0254098. doi: 10.1371/journal.pone.0254098. eCollection 2021.
PubMed 34197553Crivelli D, Polimeni E, Crotti D, Bottini G, Salvato G. Bilateral skin temperature drop and warm sensibility decrease following modulation of body part ownership through mirror-box illusion. Cortex. 2021 Feb;135:49-60. doi: 10.1016/j.cortex.2020.11.015. Epub 2020 Dec 3.
PubMed 33360760Salomon R, Lim M, Pfeiffer C, Gassert R, Blanke O. Full body illusion is associated with widespread skin temperature reduction. Front Behav Neurosci. 2013 Jul 25;7:65. doi: 10.3389/fnbeh.2013.00065. eCollection 2013.
PubMed 23898244Ronca, V., Ricci, A., Capotorto, R., Di Donato, L., Freda, D., Pirozzi, M., Palermo, E., Mattioli, L., Di Gironimo, G., Coccorese, D., Buonocore, S., Massa, F., Germano, D., Di Flumeri, G., Borghini, G., Babiloni, F., & Aricò, P. (2024). How Immersed Are You? State of the Art of the Neurophysiological Characterization of Embodiment in Mixed Reality for Out-of-the-Lab Applications. Applied Sciences, 14(18), 8192. https://doi.org/10.3390/app14188192
Hagni K, Eng K, Hepp-Reymond MC, Holper L, Keisker B, Siekierka E, Kiper DC. Observing virtual arms that you imagine are yours increases the galvanic skin response to an unexpected threat. PLoS One. 2008 Aug 28;3(8):e3082. doi: 10.1371/journal.pone.0003082.
PubMed 18769476Haggard P. Sense of agency in the human brain. Nat Rev Neurosci. 2017 Apr;18(4):196-207. doi: 10.1038/nrn.2017.14. Epub 2017 Mar 2.
PubMed 28251993Scandola M, Togni R, Tieri G, Avesani R, Brambilla M, Aglioti SM, Moro V. Embodying their own wheelchair modifies extrapersonal space perception in people with spinal cord injury. Exp Brain Res. 2019 Oct;237(10):2621-2632. doi: 10.1007/s00221-019-05618-8. Epub 2019 Aug 2.
PubMed 31375863Roth D, Latoschik ME. Construction of the Virtual Embodiment Questionnaire (VEQ). IEEE Trans Vis Comput Graph. 2020 Dec;26(12):3546-3556. doi: 10.1109/TVCG.2020.3023603. Epub 2020 Nov 10.
PubMed 32941148