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

9. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

148

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Hong Wang, bachelor's degree
  • Telefonní číslo: 02431956718
  • E-mail: 13464039936@163.com

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Aktivní komparátor: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The incidence of good functional outcomes after treatment (mRS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Shift analysis of the modified Rankin Scale (mRS)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

First People's Hospital of Shenyang

Publikace a užitečné odkazy

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Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. července 2026

Primární dokončení (Odhadovaný)

31. října 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

2. července 2026

První předloženo, které splnilo kritéria kontroly kvality

9. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

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