Environmental-Perturbation Balance Training Improves Functional Outcomes in Patients With Subacute Stroke: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The incidence of good functional outcomes after treatment (mRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stroke according to the International Symposium on Cerebral Vascular Disease criteria, with definite confirmation by imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI).
- •First-ever or recurrent cerebral hemorrhage or cerebral infarction. According to the Guidelines for the Early Management of Patients with Acute Ischemic Stroke: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association and the Chinese Guidelines for Early Rehabilitation of Stroke, rehabilitation can be initiated once the patient's condition is stable (vital signs are stable and no further progression of symptoms and signs).
- •Total NIHSS score between 5 and 20 (inclusive) prior to randomization, with a lower limb motor score ≥
- •Presence of balance dysfunction, with a miniBESTest total score ≤
- •Good compliance with rehabilitation therapy and no contraindications to active training.
- •Age between 18 and 85 years.
- •The subject or their legal representative is able and willing to provide written informed consent.
排除标准
- •History of prior cerebral hemorrhage or cerebral infarction with residual significant limb dysfunction.
- •Severe cognitive impairment or sensory aphasia that precludes communication and cooperation with treatment.
- •Concomitant severe cardiopulmonary, hepatic, or renal insufficiency, or other serious medical diseases.
- •Presence of neurological or musculoskeletal disorders affecting balance function prior to stroke onset.
- •Uncontrolled severe hypertension or diabetes mellitus.
- •Active bleeding or deep vein thrombosis.
- •Current participation in another clinical trial or rehabilitation program that may affect the results of this study.
- •Any other condition that may interfere with the outcomes of this study.
- •History of limb amputation affecting bilateral coordination or independent walking ability.
- •Pregnancy.
研究组 & 干预措施
Environmental-perturbation balance training group
Participants in the experimental group will receive environmental-perturbation balance training, at a frequency of 5 sessions per week for 8 weeks (±1 week). Each training session will be structured as follows: 30 minutes in total, consisting of a warm-up, environmental-perturbation balance training, and a cool-down period.
干预措施: Environmental-perturbation balance training (Behavioral)
Conventional rehabilitation training group
Participants in the control group will receive conventional rehabilitation training at a frequency of 5 sessions per week for 8 weeks (±1 week). Each session will be structured as follows: 30 minutes in total, consisting of a warm-up, conventional rehabilitation training, and a cool-down period.
干预措施: Conventional rehabilitation training (Behavioral)
结局指标
主要结局
The incidence of good functional outcomes after treatment (mRS)
时间窗: At 90 days post-stroke
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.
次要结局
- Shift analysis of the modified Rankin Scale (mRS)(At 90 days post-stroke)
- Modified Barthel Index(At 90 days post-stroke)
- mini-BESTest(Baseline and 90 days post-stroke)
- Overall Stability Index(At 90 days post-stroke)
- Trunk Impairment Scale(Baseline and 90 days post-stroke)
- Scale for Contraversive Pushing(Baseline and 90 days post-stroke)
- Timed Up and Go Test(At 90 days post-stroke)
- b) 6-Minute Walk Test(At 90 days post-stroke)
- Fugl-Meyer Assessment for Lower Extremity(At 90 days post-stroke)
研究者
Hong Wang
Director of the Neuro-intelligent Rehabilitation Center
First People's Hospital of Shenyang