Protocol for a multicenter prospective sequential intervention study: the effect of adaptive closed-loop postural...

Stroke often leads to hemiparetic gait, which negatively affects the quality of life and increases socioeconomic burdens. Conventional therapies have limited effectiveness in improving gait. Postural regulation deficits are a key factor contributing to gait disorders. The Gusu Constraint Standing Training (GCST), a novel posture adjustment approach, shows promise in improving central gait disorders. We hypothesize that GCST optimizes gait in hemiparetic stroke patients by enhancing their postural adaptation criticality and improving gait control through the common neural pathways and nodes shared by posture and gait. However, the specific effects and underlying mechanisms of GCST require further study.

This multicenter, prospective, sequential study will recruit 180 hemiparetic stroke patients (recovery phase: 3-6 months; chronic phase: ≥6 months post-stroke) across four hospitals, along with 30 healthy controls. GCST is divided into a structured, stepwise intervention (steps A-E) implemented sequentially based on predefined performance criteria. Assessments will be conducted at baseline, after the completion of each intervention step, and at follow-ups. The primary outcome is the minimal knee flexion angle of the hemiparetic limb during the swing phase, quantified using the three-dimensional gait analysis. Secondary outcomes include gait, postural, neuromuscular, and functional measures. Outcome assessors will be blinded to participants' stroke phase. Longitudinal data will be analyzed using linear mixed-effects models. Healthy controls will provide normative reference values.

Approved by each hospital's ethics committees, the study will require informed consent from participants. The results will be shared through academic conferences and peer-reviewed journals while ensuring participant confidentiality.

https://www.chictr.org.cn/showproj.html?proj=235182, Identifier ChiCTR2400094903.