200 Section - Early clinical trail of Dual-Knowledge-based decision support systems and intelligent clinical pathway for stroke critical-Care rehabilitation: a multi-center real-world study

We aimed to evaluate the early clinical impact of a dual-knowledge-driven intelligent decision support system (IDSS) and clinical pathway for critical-care rehabilitation in patients with stroke.

Design:

This prospective, multi-center, real-world study was conducted across nine hospital rehabilitation medicine departments in China from April to November 2025. The study comprised two parts: 1) A cross-sectional survey of healthcare providers using the system to assess their experience, satisfaction, and its impact on clinical decision-making (n=74). 2) Eligible patients with severe stroke were randomized to either the IDSS-guided rehabilitation group (n=205) or the conventional rehabilitation decision-making group (n=206). The groups were compared across functional outcomes, including consciousness, motor function, and swallowing function. The primary outcome was the change in the modified Rankin Scale (mRS) score, alongside a safety evaluation.

Results:

Clinical efficacy data revealed no statistically significant difference in the primary outcome (change in mRS score) between the two groups (p >0.05). Among the secondary outcomes, the Berg Balance Scale showed a significant improvement favoring the intervention group (p< 0.05). Although differences in other functional scales did not reach statistical significance, overall trends consistently favored the intervention group. The user survey indicated high overall satisfaction among healthcare providers (mean score >4.2/5), who perceived the system as scientific, practical, and well-integrated into clinical workflows. The system's recommendations altered the clinical decision-making process for 44.59% of users.

Conclusion:

Under real-world conditions, the rehabilitation pathway guided by IDSS demonstrated comparable effectiveness to conventional pathways in improving short-term functional outcomes for stroke critical-care patients. The system achieved widespread acceptance among healthcare providers in its early clinical application, showing promising user acceptance and potential for clinical integration. As an assistive tool, it holds substantial value for further implementation and application in the field of stroke critical-care rehabilitation.