This study innovatively proposes an "environment-perturbation balance training (E-PBT)" intervention, which delivers stable, graded environmental perturbations to keep the challenges within the manageable range. This approach can significantly reduce fear, align with the psychological characteristics of subacute stroke patients, and improve training engagement and safety, thereby filling the current research gap that has insufficiently addressed subacute patients and those with moderate-to-low functional levels. By altering the size and angle of the support surface, this training heightens patients' alertness and psychological adaptability, prompting them to actively integrate sensory information and adjust motor strategies. In turn, this can more effectively reshape internal model of balance control and facilitate genuine neuroadaptive learning in the brain. Moreover, this training more closely mimics real-life fall scenarios, with the aim of directly cultivating the proactive postural control and strategic decision-making abilities required in daily living.
This study aims to systematically evaluate the efficacy of this E-PBT intervention on functional recovery in patients during the subacute stage of stroke through a prospective randomized controlled trial, and to explore its potential effects on balance ability, activities of daily living, and overall functional outcomes, thereby providing a more effective and clinically translatable new strategy for post-stroke rehabilitation.
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Parallel
Environmental-perturbation balance training
BehavioralThe core principle of this training is to deliver standardized, controllable environmental perturbations tailored to the patient's functional level. All perturbations will be administered under safe conditions, following a stepwise "challenge-adapt-rechallenge" progression principle, with the aim of maximizing the patient's active postural control strategies and neuromuscular adaptation, thereby improving balance function and ultimately facilitating the patient's return to home and community life.
Conventional rehabilitation training
BehavioralParticipants in the control group will receive conventional rehabilitation training based on the principles of neuro-developmental therapy (NDT) and motor relearning programme (MRP). The training will include static and dynamic sitting and standing balance, weight shifting, single-leg stance, weight-bearing exercises, core stabilization training, straight-line walking on firm, level ground, and step up and down exercises.
The incidence of good functional outcomes after treatment (mRS)
The primary outcome of this study is the improvement in neurological functional outcome at 90 days post-stroke, as measured by the modified Rankin Scale (mRS). The mRS is a 7-level ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. For clinical interpretability and statistical analysis, the mRS will be dichotomized as follows: a favorable outcome is defined as an mRS score of ≤ 3 (indicating the ability to walk independently or with minimal assistance), and an unfavorable outcome is defined as an mRS score of ≥ 4 (indicating inability to walk independently and requiring assistance in daily activities). At 90 days (±7 days) after stroke, the mRS score will be assessed by trained evaluators who are blinded to group allocation, through face-to-face interviews or telephone follow-ups. The primary comparison will be the difference in the proportion of favorable outcomes (i.e., mRS ≤ 3) between the two groups.
Shift analysis of the modified Rankin Scale (mRS)
In contrast to the primary binary outcome, the shift analysis will be able to capture the treatment effect of E-PBT on the functional prognosis of post-stroke patients more sensitively, by avoiding information loss associated with the use of a fixed dichotomization threshold.
Modified Barthel Index
Activities of daily living will be assessed using the Modified Barthel Index (MBI), which consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate greater independence in daily living. The assessment will be administered through a structured interview to capture the patient's actual performance during the preceding week.
mini-BESTest
Balance function will be assessed using the mini-Balance Evaluation Systems Test (mini-BESTest), which consists of 14 items with a total score ranging from 0 to 28. Higher scores indicate better dynamic balance ability. This scale has been demonstrated to have good responsiveness to changes in balance function in stroke patients.
Overall Stability Index
The Overall Stability Index will be measured using the balance function training and assessment system (XY-PH-V) to quantify the displacement of the center of pressure (COP) during static standing. A lower OSI value indicates better postural control ability. Since the majority of participants are unable to stand independently at baseline, this outcome will only be collected after the completion of the intervention.
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