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Идёт набор NCT07546864

Comparative Effects of Mirror Therapy and Cognitive Orientation to Daily Occupational Performance in Stroke: A Randomized Controlled Trial

Без фазы С лечением Stroke Stroke Rehabilitaion

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: Mirror Therapy, Cognitive Orientation to Daily Occupational Performance (CO-OP), Conventional Occupational Therapy, Robotic Balance Training.
Кому может быть актуально
Состояния в реестре: Stroke, Stroke Rehabilitaion. Базовые параметры: от 18 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Effects of Mirror Therapy, Cognitive Orientation to Daily Occupational Performance, and Conventional Occupational Therapy in Individuals With Stroke: A 3-Month Follow-Up Randomized Controlled Trial

Обзор

This study aims to compare the effectiveness of three rehabilitation approaches in individuals with stroke: mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), and conventional occupational therapy (COT), all combined with robotic balance training. A total of 45 individuals with subacute and chronic stroke will be randomly assigned to one of three groups. Each group will receive 4 weeks of intervention (5 sessions per week), followed by a 3-month follow-up period. Outcomes related to motor function, somatosensory function, activities of daily living, participation, and quality of life will be assessed at baseline, after intervention, and at follow-up. The study aims to determine which intervention approach is more effective in improving functional outcomes in individuals with stroke.

Подробное описание

Stroke is one of the leading causes of disability worldwide, often resulting in motor, sensory, and cognitive impairments. Rehabilitation approaches that enhance neuroplasticity are essential for improving functional recovery.

This randomized controlled trial aims to compare the effectiveness of mirror therapy (MT), cognitive orientation to daily occupational performance (CO-OP), and conventional occupational therapy (COT), all combined with robotic balance training (RBT), in individuals with stroke.

Participants will be recruited from a physical therapy and rehabilitation unit and will be randomly assigned into three groups: MT, CO-OP, and COT. All groups will receive robotic balance training as a priming intervention prior to therapy sessions.

Each intervention will be administered for 4 weeks, 5 days per week. In addition, a transfer package will be applied to enhance the generalization of therapeutic gains to daily life activities.

Outcome measures will include motor function, somatosensory function, occupational performance, activities of daily living, participation, self-efficacy, and quality of life. Assessments will be conducted at baseline, post-intervention, and at a 3-month follow-up.

The findings of this study are expected to provide evidence for the comparative effectiveness of different rehabilitation approaches in stroke and contribute to clinical decision-making.

Вмешательства

  • Поведенческое Mirror Therapy
    Mirror therapy involves the use of a mirror to create a visual illusion of movement of the affected limb by observing the reflection of the unaffected limb. Task-oriented activities are performed to improve motor function and sensory integration in individuals with stroke.
  • Поведенческое Cognitive Orientation to Daily Occupational Performance (CO-OP)
    CO-OP is a client-centered, performance-based approach that uses cognitive strategies to enable skill acquisition. Participants identify meaningful goals and use guided discovery and problem-solving strategies to improve task performance.
  • Поведенческое Conventional Occupational Therapy
    Conventional occupational therapy includes task-oriented interventions such as reaching, grasping, coordination training, strengthening exercises, and activities aimed at improving functional independence in daily living.
  • Другое Robotic Balance Training
    Robotic balance training is used as a priming intervention before therapy sessions. It includes repetitive, task-specific movements involving weight shifting, postural control, and balance training to enhance motor responses.

Первичные конечные точки

  • Fugl-Meyer Motor Assessment (FMA) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
Вторичные конечные точки (6)
  • Revised Nottingham Sensory Assessment (rNSA) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
  • Canadian Occupational Performance Measure (COPM) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
  • Modified Barthel Index (MBI) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
  • Stroke Impact Scale (SIS) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
  • Stroke Self-Efficacy Questionnaire (SSEQ) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]
  • Community Integration Questionnaire (CIQ) [Срок оценки: Baseline, post-intervention (4 weeks), and 3-month follow-up]

Критерии участия

Критерии включения

  • \- Individuals diagnosed with ischemic or hemorrhagic stroke
  • Age 18 years and older
  • Subacute (3-6 months post-stroke) or chronic stage (6-12 months post-stroke)
  • Brunnstrom Motor Recovery Stage ≥3 for upper extremity, ≥4 for hand, and ≥4 for lower extremity
  • Mini-Mental State Examination (MMSE) score ≥24
  • No severe visual, orthopedic, or additional neurological impairments
  • Not participating in another study during the research period
  • Voluntary consent to participate in the study

Критерии исключения

  • \- Poor motor coordination or major medical problems that would prevent participation
  • Presence of Wernicke's aphasia
  • Botulinum toxin injection within the last 3 months
  • Psychiatric conditions that may interfere with participation (e.g., depression, ongoing psychiatric treatment, low motivation)

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
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bayburt State Hospital — Bayburt

Идентификаторы

NCT: NCT07546864 · MT_COOP_STROKE_2026_NB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗