Environmental-perturbation Balance Training Improves Functional Outcomes in Patients With Subacute Stroke

NCT07697794 | Not Yet Recruiting

• 1 other identifier: RehaWang-2026-01
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Subacute stage; Functional prognosis; Environment-perturbation balance training; Randomized controlled trial; Modified Rankin Scale

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

Study Arms (2)

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.

Behavioral: Environmental-perturbation balance training

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.

Behavioral: Conventional rehabilitation training

Interventions

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.

Environmental-perturbation balance training group

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.

Conventional rehabilitation training group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Shenyang: lead

Study Sites (1)

Shenyang First People's Hospital

Shenyang, Liaoning, 110041, China

Location

Related Publications (13)

• 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.

  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.

  PMID: 31662037 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.

  PMID: 30121600 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.

  PMID: 37626565 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.

  PMID: 30630753 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.

  PMID: 32978705 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.

  PMID: 30195219 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.

  PMID: 36501958 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.

  PMID: 30616984 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.

  PMID: 35910084 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.

  PMID: 22494388 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.

  PMID: 34785599 BACKGROUND

• 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.

  PMID: 32389061 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hong Wang, bachelor's degree

CONTACT

02431956718; 13464039936@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neuro-intelligent Rehabilitation Center

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

CN (1)