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Environmental-perturbation Balance Training Improves Functional Outcomes in Patients With Subacute Stroke (E-PBT)

9. juli 2026 opdateret af: Hong Wang, First People's Hospital of Shenyang

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

148

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Liaoning
      • Shenyang, Liaoning, Kina, 110041
        • Shenyang First People's Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Beskrivelse

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[11] and the Chinese Guidelines for Early Rehabilitation of Stroke[12], 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 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Environmental-perturbation balance training
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.
Aktiv komparator: 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.
Adfærdsmæssigt: Conventional rehabilitation training
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The incidence of good functional outcomes after treatment (mRS)
Tidsramme: 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.
At 90 days post-stroke

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shift analysis of the modified Rankin Scale (mRS)
Tidsramme: At 90 days post-stroke
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
Modified Barthel Index
Tidsramme: At 90 days post-stroke
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
Tidsramme: Baseline and 90 days post-stroke
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
Tidsramme: At 90 days post-stroke
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
Tidsramme: Baseline and 90 days post-stroke
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
Tidsramme: Baseline and 90 days post-stroke
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
Tidsramme: At 90 days post-stroke
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
Tidsramme: At 90 days post-stroke
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
Tidsramme: At 90 days post-stroke
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First People's Hospital of Shenyang

Publikationer og nyttige links

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Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

31. oktober 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RehaWang-2026-01

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