Environmental-perturbation Balance Training Improves Functional Outcomes in Patients With Subacut… (NCT07697794) | Clinical Trial Compass
WithdrawnNot Applicable
Environmental-perturbation Balance Training Improves Functional Outcomes in Patients With Subacute Stroke
Stopped: Principal Investigator decided to withdraw the study prior to enrollment based on internal strategic review
China0Started 2026-07-20
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 ≥2.
* Presence of balance dysfunction, with a miniBESTest total score ≤12.
* 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.
Exclusion Criteria:
* 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 musc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of good functional outcomes after treatment (mRS)