Immersive virtual reality with synchronous neurostimulation for upper-limb recovery after stroke: a randomized...

Stroke affects 15 million people annually and leaves 5 million permanently disabled. In the chronic phase (>3 months after stroke), patients often experience persistent sensorimotor deficits and altered body representation, yet rehabilitation delivery remains partial and inconsistent, highlighting an unmet clinical need. Immersive technologies and noninvasive neurostimulation offer potential for scalable, intensive rehabilitation, but clinical evidence supporting multimodal approaches and objective outcome assessments remains limited. In this study, we evaluate the feasibility, clinical efficacy and assessment capabilities of a multimodal platform (MultiSensy) integrating virtual reality with synchronous transcutaneous sensory neurostimulation. Thirty-four patients with chronic stroke were enrolled in a combined pilot study (n = 9) and randomized, 33-day-long feasibility study (n = 25), where MultiSensy intervention was evaluated against conventional rehabilitation. Primary endpoints included motor function assessed by Fugl-Meyer Assessment Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) and self-body representation assessed by the Body Landmark Test. Secondary outcomes included sensory and functional independence evaluation. Continuous kinematic data were collected to derive objective performance markers. Compared to conventional rehabilitation, MultiSensy resulted in greater motor improvement, reflected by higher FMA-UE (13.17 ± 1.30 versus 7.54 ± 1.48; P = 0.01) and ARAT (8.25 ± 1.96 versus 2.44 ± 1.08; P = 0.029) scores. MultiSensy further improved body self-representation and hand tactile acuity. The platform enabled continuous performance monitoring and extraction of objective kinematic markers that tracked rehabilitation progress. These findings pave the way for larger trials and highlight the potential treatment of multiple patients with fewer physiotherapist visits needed or even home-based sensorimotor rehabilitation. ClinicalTrials.gov identifier: NCT06400823 .