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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Environmental-perturbation balance training group | Experimental | 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. |
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| Conventional rehabilitation training group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Environmental-perturbation balance training | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 90 days post-stroke |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 90 days post-stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Wang, bachelor's degree | Contact | 02431956718 | 13464039936@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenyang First People's Hospital | Shenyang | Liaoning | 110041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 中华医学会神经病学分会, 中华医学会神经病学分会神经康复学组, 中华医学会神经病学分会脑血管病学组. 中国脑卒中早期康复治疗指南 [J]. 中华神经科杂志, 2017, 50(06): 405-12. | ||
| 31662037 | Background | Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30. | |
| 30121600 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 19, 2026 | Jul 9, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Conventional rehabilitation training | Behavioral | Participants 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. |
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| 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. | At 90 days post-stroke |
| 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. | Baseline and 90 days post-stroke |
| 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. | At 90 days post-stroke |
| Trunk Impairment Scale | Trunk function will be assessed using the Trunk Impairment Scale (TIS), which consists of three subscales: static sitting balance, dynamic sitting balance, and coordination. The total score ranges from 0 to 23, with higher scores indicating better trunk control. | Baseline and 90 days post-stroke |
| Scale for Contraversive Pushing | The presence of pusher syndrome will be evaluated using the Scale for Contraversive Pushing (SCP). The SCP comprises the following three items: (1) asymmetry of posture, (2) abduction or extension of the non-paretic limb, and (3) resistance to passive correction of posture. Pusher syndrome is considered to be present when the score for each of the three SCP items is > 0. | Baseline and 90 days post-stroke |
| Timed Up and Go Test | The TUG will record the time (in seconds) required for the participant to rise from a chair, walk 3 meters, turn around, return, and sit down again. Shorter times indicate better mobility. The use of assistive devices is permitted during the test, but physical assistance from others is not allowed. | At 90 days post-stroke |
| b) 6-Minute Walk Test | The 6MWT will record the total distance (in meters) that the participant can walk as far as possible within 6 minutes. If the test is terminated early due to fatigue or safety concerns, the actual distance walked and the reason for termination will be recorded. | At 90 days post-stroke |
| Fugl-Meyer Assessment for Lower Extremity | Lower extremity motor function will be assessed using the Fugl-Meyer Assessment for Lower Extremity (FMA-LE). The scale consists of 17 items, with a total score ranging from 0 to 34. Higher scores indicate better lower limb motor function. | At 90 days post-stroke |
| Background |
| Mansfield A, Aqui A, Danells CJ, Knorr S, Centen A, DePaul VG, Schinkel-Ivy A, Brooks D, Inness EL, Mochizuki G. Does perturbation-based balance training prevent falls among individuals with chronic stroke? A randomised controlled trial. BMJ Open. 2018 Aug 17;8(8):e021510. doi: 10.1136/bmjopen-2018-021510. |
| 37626565 | Background | Hu N, Piirainen JM, Kidgell DJ, Walker S, Avela J. Corticospinal Adaptation to Short-Term Horizontal Balance Perturbation Training. Brain Sci. 2023 Aug 15;13(8):1209. doi: 10.3390/brainsci13081209. |
| 30630753 | Background | Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7. |
| 32978705 | Background | Liu X, Bhatt T, Wang Y, Wang S, Lee A, Pai YC. The retention of fall-resisting behavior derived from treadmill slip-perturbation training in community-dwelling older adults. Geroscience. 2021 Apr;43(2):913-926. doi: 10.1007/s11357-020-00270-5. Epub 2020 Sep 25. |
| 30195219 | Background | Yang F, Cereceres P, Qiao M. Treadmill-based gait-slip training with reduced training volume could still prevent slip-related falls. Gait Posture. 2018 Oct;66:160-165. doi: 10.1016/j.gaitpost.2018.08.029. Epub 2018 Aug 25. |
| 36501958 | Background | Ferreira RN, Ribeiro NF, Figueiredo J, Santos CP. Provoking Artificial Slips and Trips towards Perturbation-Based Balance Training: A Narrative Review. Sensors (Basel). 2022 Nov 28;22(23):9254. doi: 10.3390/s22239254. |
| 30616984 | Background | Wang Y, Bhatt T, Liu X, Wang S, Lee A, Wang E, Pai YC. Can treadmill-slip perturbation training reduce immediate risk of over-ground-slip induced fall among community-dwelling older adults? J Biomech. 2019 Feb 14;84:58-66. doi: 10.1016/j.jbiomech.2018.12.017. Epub 2018 Dec 14. |
| 35910084 | Background | Alayat MSM, Almatrafi NA, El Fiky AAR, Elsodany AM, Shousha TM, Basuodan R. The Effectiveness of Perturbation-Based Training in the Treatment of Patients With Stroke: A Systematic Review and Meta-Analysis. Neurosci Insights. 2022 Jul 23;17:26331055221114818. doi: 10.1177/26331055221114818. eCollection 2022. |
| 22494388 | Background | Batchelor FA, Mackintosh SF, Said CM, Hill KD. Falls after stroke. Int J Stroke. 2012 Aug;7(6):482-90. doi: 10.1111/j.1747-4949.2012.00796.x. Epub 2012 Apr 12. |
| 34785599 | Background | Saini V, Guada L, Yavagal DR. Global Epidemiology of Stroke and Access to Acute Ischemic Stroke Interventions. Neurology. 2021 Nov 16;97(20 Suppl 2):S6-S16. doi: 10.1212/WNL.0000000000012781. |
| 32389061 | Result | Grimley RS, Rosbergen IC, Gustafsson L, Horton E, Green T, Cadigan G, Kuys S, Andrew NE, Cadilhac DA. Dose and setting of rehabilitation received after stroke in Queensland, Australia: a prospective cohort study. Clin Rehabil. 2020 Jun;34(6):812-823. doi: 10.1177/0269215520916899. Epub 2020 May 11. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |