Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

9 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

148

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Hong Wang, bachelor's degree
  • Numero di telefono: 02431956718
  • Email: 13464039936@163.com

Luoghi di studio

  • Cina
    • Liaoning
      • Shenyang, Liaoning, Cina, 110041
        • Shenyang First People's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The incidence of good functional outcomes after treatment (mRS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Shift analysis of the modified Rankin Scale (mRS)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

First People's Hospital of Shenyang

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

20 luglio 2026

Completamento primario (Stimato)

31 ottobre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RehaWang-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Macedonia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi