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Идёт набор NCT07631182

Action Observation Therapy in Chronic Stroke Via Telerehabilitation

Без фазы С лечением Chronic Stroke

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: Conventional physiotherapy.
Кому может быть актуально
Состояния в реестре: Chronic Stroke. 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

Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients

Обзор

Stroke, a leading cause of disability worldwide, particularly affects upper extremity function, rendering individuals dependent on others for daily living activities and reducing their quality of life. To mitigate these effects, Action Observation Therapy (AOT), which has gained prominence in recent years, activates the mirror neuron system, triggering learning processes in the motor cortex and supporting functional recovery through the imitation of observed movements. Furthermore, telerehabilitation offers a significant advantage in facilitating access to rehabilitation services for these patients requiring long-term treatment, eliminating barriers such as transportation and cost. The absence of studies in the literature comparing the effectiveness of combining these two methods on hand skills and quality of life in individuals with chronic stroke with conventional physiotherapy makes investigating the clinical value of this approach academically unique and necessary.

Подробное описание

Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.

Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.

Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.

Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.

A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.

Вмешательства

  • Другое Conventional physiotherapy
    All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic. These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.

Первичные конечные точки

  • Spasticity [Срок оценки: Baseline]
  • Stage of hemiplegia [Срок оценки: Baseline]
  • Motor function [Срок оценки: Baseline, five week later (after intervention)]
  • Dominant side [Срок оценки: Baseline]
  • Upper extremity function [Срок оценки: Baseline, five week later (after intervention)]
  • Functional Independence [Срок оценки: Baseline, five week later (after intervention)]
  • Cognitif Function [Срок оценки: Baseline]
  • Neglect [Срок оценки: Baseline]
  • Life Quality [Срок оценки: Baseline, five week later (after intervention)]

Критерии участия

Критерии включения

  • Being over 18 years of age,
  • Diagnosis of left hemiparetic stroke,
  • Having passed between 6 months since the onset of stroke,
  • Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
  • Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
  • Scoring 24 or more points from the Mini Mental Test

Критерии исключения

  • Unwillingness to participate in the study,
  • Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
  • Having a contracture in any of the affected upper extremity joints,
  • Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
  • Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
  • Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
  • Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
  • Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 2 центра
  • Karabuk University — Karabük
  • Mustafa KAVAK — Karabük

Публикации

  • Mancuso M, Tondo SD, Costantini E, Damora A, Sale P, Abbruzzese L. Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Brain Sci. 2021 Feb 26;11(3):290. doi: 10.3390/brainsci11030290. PMID 33652680
  • Shamili A, Hassani Mehraban A, Azad A, Raissi GR, Shati M. Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial. Neural Plast. 2022 Sep 16;2022:5284044. doi: 10.1155/2022/5284044. eCollection 2022. PMID 36160327

Идентификаторы

NCT: NCT07631182 · Karabuk-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗