An interventional study of Immersive Virtual Reality Embodiment Manipulations in Spinal Cord Injury, Stroke and Healthy, sponsored by IRCCS Eugenio Medea. Recruiting at 1 site in Italy. Open to participants aged 12 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Basic science
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.
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).
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's planned enrollment of 90 is above the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 55 are open to participants now.
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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.
Behavioral: Immersive Virtual Reality Embodiment Manipulations
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.
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).
Time frame: Immediately after each VR condition on Day 1, Day 2, and Day 3.
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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: During each VR condition on Day 2 (120 seconds)
Plan to share: Undecided
Started Feb 2026 (actual). Primary completion is estimated for Aug 2028, 30 months after the start.
Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 30 months is below that.
Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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