Synergistic effects of early sequential enhanced external counterpulsation and electric tilt table training on functional recovery in ischemic stroke: study protocol of a randomized controlled trial.

Background: Ischemic stroke remains a leading cause of disability worldwide. Early rehabilitation is crucial for functional recovery. Electric tilt table (ETT) training improves motor and balance function and facilitates early mobilization in bedridden patients, but its use is often limited by orthostatic hypotension (OH). Enhanced external counterpulsation (EECP), a noninvasive circulatory support technique, has shown benefits in cardiovascular and cerebrovascular diseases by improving vascular function and cardiac output. Given its hemodynamic effects, EECP may enhance tolerance to verticalization. However, whether early sequential application of EECP followed by ETT training improves functional recovery after ischemic stroke remains unclear. This study aims to determine whether this sequential strategy improves neurological and functional recovery while reducing symptomatic orthostatic hypotension in patients with ischemic stroke. Methods: This single-center, randomized controlled clinical trial will be conducted at Beijing Rehabilitation Hospital, Capital Medical University. A total of 104 participants with ischemic stroke within 3 months of onset will be enrolled and randomly allocated in a 1:1 ratio to either the ETT training group (conventional rehabilitation plus once-daily 30-min ETT training) or the sequential EECP - ETT training group (conventional rehabilitation plus once-daily 60-min EECP immediately followed by 30-min ETT training). Both interventions will be delivered 5 days per week for 7 weeks. The primary outcome is overall neurological function at week 7, assessed by the National Institutes of Health Stroke Scale (NIHSS). Secondary outcomes include the incidence of symptomatic OH during ETT training sessions, motor function (Fugl-Meyer Assessment, FMA), balance (Berg Balance Scale, BBS), swallowing (Modified Mann Assessment of Swallowing Ability, MMASA), activities of daily living (Barthel Index, BI), and noninvasive hemodynamic parameters (cardiac index, stroke volume, systemic vascular resistance index) assessed at week 7. Outcome assessments will be performed by blinded evaluators. Safety will be monitored throughout the study period. Discussion: This study will evaluate the sequential application of EECP and ETT in early ischemic stroke rehabilitation. The findings will clarify whether this strategy safely alleviates symptomatic orthostatic hypotension and promotes overall functional recovery, potentially offering an effective and integrative approach for early stroke intervention. Trial registration: http://www.chictr.org.cn, Chinese Clinical Trial Registry, ChiCTR2400083761. Registered on April 30, 2024.