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StrokeE-PBTNCT07697794

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

A study testing Environmental-perturbation balance training and Conventional rehabilitation training in people with Stroke, run by First People's Hospital of Shenyang at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Environmental-perturbation balance training and Conventional rehabilitation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
20 Jul 2026to 1 Dec 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenyang First People's Hospital

    Shenyang, Liaoning, 110041

Other trials in China

About this study

Official title: Environmental-Perturbation Balance Training Improves Functional Outcomes in Patients With Subacute Stroke: A Prospective Randomized Controlled Trial

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
Being tested
Environmental-perturbation balance training, Conventional rehabilitation training
Keywords
Stroke, Subacute stage, Functional prognosis, Environment-perturbation balance training, Randomized controlled trial, Modified Rankin Scale
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Environmental-perturbation balance trainingBehavioural

    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.

  • Conventional rehabilitation trainingBehavioural

    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.

Study groups in NCT07697794
Study groupRoleWhat they receive
Environmental-perturbation balance training groupExperimentalParticipants 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.
Receives: Behavioral: Environmental-perturbation balance training
Conventional rehabilitation training groupActive comparatorParticipants 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.
Receives: Behavioral: Conventional rehabilitation training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 90 days post-stroke

Secondary outcomes (9)

  1. 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.

    Measured: At 90 days post-stroke

  2. 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.

    Measured: At 90 days post-stroke

  3. 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.

    Measured: Baseline and 90 days post-stroke

  4. 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.

    Measured: At 90 days post-stroke

  5. 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.

    Measured: Baseline and 90 days post-stroke

  6. 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.

    Measured: Baseline and 90 days post-stroke

  7. 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.

    Measured: At 90 days post-stroke

  8. 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.

    Measured: At 90 days post-stroke

  9. 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.

    Measured: At 90 days post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start20 Jul 2026 (estimated)
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Why it stopped: Principal Investigator decided to withdraw the study prior to enrollment based on internal strategic review

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07697794
Sponsor's protocol ID
RehaWang-2026-01
Acronym
E-PBT
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

  • 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.

    PubMed 31662037

  • 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.

    PubMed 30121600

  • 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.

    PubMed 37626565

  • 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.

    PubMed 30630753

  • 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.

    PubMed 32978705

  • 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.

    PubMed 30195219

  • 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.

    PubMed 36501958

  • 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.

    PubMed 30616984

  • 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.

    PubMed 35910084

  • 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.

    PubMed 22494388

  • 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.

    PubMed 34785599

  • 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.

    PubMed 32389061

Questions about this trial

What is this clinical trial studying?

A study testing Environmental-perturbation balance training and Conventional rehabilitation training in people with Stroke, run by First People's Hospital of Shenyang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of good functional outcomes after treatment (mRS) (time frame: At 90 days post-stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07697794, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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