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Набор скоро начнётся NCT07494357

Effects of Dual Task-Oriented Circuit Training on Walking Recovery in Sub-acute Stroke

Без фазы С лечением Stroke, Cerebrovascular

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dual task oriented circuit training, Task Oriented Circuit Training, Dual task training.
Кому может быть актуально
Состояния в реестре: Stroke, Cerebrovascular. Базовые параметры: 40 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индонезия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Dual Task-Oriented Circuit Training on Neuroplasticity and Walking Adaptability in Subacute Stroke Patients: A Pilot and Feasibility Study

Обзор

This pilot study aims to assess the feasibility, safety, and initial efficacy of an integrated Dual Task-Oriented Circuit Training (DTOCT) program for individuals in the subacute phase of stroke recovery. Although numerous patients recover the capacity to walk in a regulated hospital environment, they frequently encounter difficulties with "community ambulation," the capability to traverse real-world settings while multitasking (e.g., walking while conversing or circumventing barriers). This study will examine if the integration of high-intensity circuit training with cognitive difficulties can promote neuroplasticity and enhance the patient's capacity to safely traverse intricate daily settings.

Подробное описание

Cognitive-Motor Interference (CMI) makes it challenging for stroke survivors to reintegrate into their communities. Walking is an automatic subcortical process in a healthy brain. After a stroke, however, the brain often has to "consciously" control walking, which takes away mental resources from other tasks. This "functional gap" is why almost 80% of survivors can walk house-hold, but only 30% can safely get around in the community. This study examines the "Golden Window" of recovery (2 weeks to 5 months post-stroke), a timeframe characterized by optimal physiological conditions for neuroplasticity. The DTOCT protocol functions as a synergistic intervention: the circuit training induces cardiovascular intensity to stimulate systemic Brain-Derived Neurotrophic Factor (BDNF) release, while concurrent cognitive tasks (e.g., memory recall or the Stroop test) focus on localized neurotrophic support within the prefrontal cortex and hippocampus. This three-arm pilot study (DTOCT vs. pure task-oriented training vs. pure dual-tasking) will give us important information about how easy it is to recruit participants, how well they stick to the plan, and how big the initial effects are. These results will constitute an essential basis for an upcoming comprehensive Randomized Controlled Trial (RCT) designed to enhance the standard of neurorehabilitation in Indonesia.

Вмешательства

  • Поведенческое Dual task oriented circuit training
    1\. Experimental Arm: Dual Task-Oriented Circuit Training (DTOCT) Intervention Name: Behavioral: Dual Task-Oriented Circuit Training (DTOCT) Description: Participants will undergo an integrated 60-minute rehabilitation session, 3 times per week for 4 weeks (total 12 sessions). Each session includes 25-50 minutes of active circuit training across five specialized stations: Dual-Task Walking: Straight walking (3-8m) while performing forward/backward number sequencing. Obstacle Walking: Steppin
  • Поведенческое Task Oriented Circuit Training
    2\. Active Comparator Arm: Task-Oriented Circuit Training (TOCT) Intervention Name: Behavioral: Task-Oriented Circuit Training (TOCT) Description: Participants will focus exclusively on functional motor relearning and cardiovascular endurance through 6 circuit-based stations: Standing and Reaching: Multidirectional reaching to targets while standing. Sit-to-Stand: Transitions using chairs of various heights to strengthen extensors. Anterior/Posterior Stepping: Stepping onto blocks of various
  • Поведенческое Dual task training
    3\. Active Comparator Arm: Pure Dual-Task Training (DT) Intervention Name: Behavioral: Pure Dual-Task Training (DT) Description: Participants will perform standard, non-circuit walking at a self-selected comfortable speed while executing simultaneous cognitive demands. The protocol includes: Backward Counting: Continuous subtraction from a random 3-digit number. Stroop Task: Identifying font colors or semantic meanings of incongruent words. Memory Tasks: Sequential recall of shopping lists (3

Первичные конечные точки

  • Adherence Rate [Срок оценки: 4 weeks]
  • Retention Rate [Срок оценки: 4 weeks]
  • Incidence of Adverse Events [Срок оценки: 4 weeks]
  • Mean Exercise Heart Rate [Срок оценки: During each of the 12 training sessions (4 weeks)]
  • Mean Systolic and Diastolic Blood Pressure [Срок оценки: Pre-and post-each training session (4 weeks)]
  • Mean Borg Rating of Perceived Exertion (RPE) Score [Срок оценки: At the end of each circuit station during all 12 sessions (4 weeks)]
Вторичные конечные точки (6)
  • Change from Baseline in 6-Minute Walk Test (6MWT) [Срок оценки: Baseline and 4 weeks]
  • Change from Baseline in 10-Meter Walk Test (10MWT) [Срок оценки: Baseline and 4 weeks]
  • Change from Baseline of Completion Time in Standardized Walking Obstacle Course (SWOC) [Срок оценки: Baseline and 4 weeks]
  • Change from Baseline in Standardized Walking Obstacle Course (SWOC) Step Count [Срок оценки: Baseline and 4 weeks]
  • Change of number of errors in Standardized Walking Obstacle Course (SWOC) [Срок оценки: Baseline and 4 weeks (Post-intervention)]
  • Change from Baseline in Serum BDNF Concentration [Срок оценки: Baseline and 4 weeks]

Критерии участия

Критерии включения

  • Diagnosed with a first-ever subacute stroke (defined as 2 weeks to 5 months post-onset) with anterior circulation involvement.
  • Diagnosis confirmed via neuroimaging (CT or MRI).
  • Men and women aged 40 to 65 years.
  • Motor recovery in the lower limbs corresponding to Brunnstrom stages 4 to
  • Functional Ambulation Category (FAC) score of at least grade 3.
  • Ability to walk independently, with or without walking aids.
  • Montreal Cognitive Assessment Indonesian version (MoCA-INA) score of ≥20, demonstrating the capacity to collaborate and follow multi-step instructions.
  • Medically stable with controlled comorbidities.

Критерии исключения

  • Expressive or receptive aphasia that impedes task comprehension
  • Unstable cardiovascular or medical conditions (e.g., severe hypertension, congestive heart failure) for which moderate exercise is contraindicated.
  • Moderate to severe depression, indicated by a Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Индонезия · 1 центр
  • RS Dustira Bandung — Bandung

Идентификаторы

NCT: NCT07494357 · IKFR-202603.01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗